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Merck & Co., Inc. (MRK)

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87.20 +0.56 (+0.65%)
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  • C
    Cured
    $SLS conversation
    Shares are Cheap: 8 PR’s in 90 days - $20 per share followed by the FDA Green Light for AML $2B in Proj Rev.
    1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
    Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    $7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations. The Joint Analysis can only improve on what is already better given Gps pristine safety profile.

    - Median Overall Survival not reached at a median follow-up of 43.1 weeks -

    2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
    https://www.mskcc.org/cancer-care/clinical-trials/17-654

    3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
    Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.

    4. $MRK Partnership / potential Upfront Money

    5. $BMY Partnerhip / potential upfront Money

    6. 3D Med Trial Initiation (s)

    7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
    Gps MRD+ Post ACST Trial Planned

    8. GFH009 Preliminary Trial Result / ( before the final Safety reading) - CDK9 agents have proven very efficacious albeit with significant, insurmountable side affects. GFH009 will be the first to achieve a safety profile that can be useful in practice.

    GPS Phase 3 is a Registrational trial - meaning the parameters are pre approved by the fda - if their is a positive read at The Midpoint interim - and its powered to do so - the fda approval could happen in as little as 3 months from now along with a $100 share price.

    Ceo stated Fda review Q1Q2 Multibillion dollar Phase 3 Fda Review and Triple digits Just about 3 months out NOW - Shares are cheap. The primary endpoint of the REGAL study is overall survival, and the study's powered at 90%, with assumptions of a median overall survival of only 10 months inthe GPS arm, versus 5.4 months in the best available treatment arm.

    To declare statistical significance, i.e., a positive study for efficacy, one would need either a hazard ratio of less than 0.6 at interim analysis, or a hazard ratio of less than 0.675 at final analysis. ( <-- Approval at Interim)

    Interim analysis will consist of one single readout for efficacy by the independent data monitoring committee after the first 80 deaths. Both the independent data monitoring committee and the study steering committee have been established and consist of internationally renowned leukemia and biostatistical experts, including Dr. Tom Fleming, the global principle investigator; Dr. Hagop #$%$arjian, Chief of the Leukemia Department at the MD Anderson Cancer Center, and the world renowned clinical trialist in AML responsible for the successful delivery of several agents currently FDA approved for this malignancy.
  • C
    Cured
    $SLS conversation
    Shares are Cheap: 8 PR’ in 90 days - $20 per share followed by the FDA Green Light for AML $2B in Proj Rev.
    1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
    Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    $7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations. The Joint Analysis can only improve on what is already better given Gps pristine safety profile.

    - Median Overall Survival not reached at a median follow-up of 43.1 weeks -

    2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
    https://www.mskcc.org/cancer-care/clinical-trials/17-654

    3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
    Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.

    4. $MRK Partnership / potential Upfront Money

    5. $BMY Partnerhip / potential upfront Money

    6. 3D Med Trial Initiation (s)

    7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
    Gps MRD+ Post ACST Trial Planned

    8. GFH009 Preliminary Trial Result / ( before the final Safety reading) - CDK9 agents have proven very efficacious albeit with significant, insurmountable side affects. GFH009 will be the first to achieve a safety profile that can be useful in practice.

    GPS Phase 3 is a Registrational trial - meaning the parameters are pre approved by the fda - if their is a positive read at The Midpoint interim - and its powered to do so - the fda approval could happen in as little as 3 months from now along with a $100 share price.

    Ceo stated Fda review Q1Q2 Multibillion dollar Phase 3 Fda Review and Triple digits Just about 3 months out NOW - Shares are cheap. The primary endpoint of the REGAL study is overall survival, and the study's powered at 90%, with assumptions of a median overall survival of only 10 months inthe GPS arm, versus 5.4 months in the best available treatment arm.

    To declare statistical significance, i.e., a positive study for efficacy, one would need either a hazard ratio of less than 0.6 at interim analysis, or a hazard ratio of less than 0.675 at final analysis. ( <-- Approval at Interim)

    Interim analysis will consist of one single readout for efficacy by the independent data monitoring committee after the first 80 deaths. Both the independent data monitoring committee and the study steering committee have been established and consist of internationally renowned leukemia and biostatistical experts, including Dr. Tom Fleming, the global principle investigator; Dr. Hagop #$%$arjian, Chief of the Leukemia Department at the MD Anderson Cancer Center, and the world renowned clinical trialist in AML responsible for the successful delivery of several agents currently FDA approved for this malignancy.
  • C
    Cured
    $SLS conversation
    8 PR’s within 90 days - imo $20 per share followed by the FDA Green Light for $2B in AML Rev.
    1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
    Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    $7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations. The Joint Analysis can only improve on what is already better given Gps pristine safety profile.

    - Median Overall Survival not reached at a median follow-up of 43.1 weeks -

    2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
    https://www.mskcc.org/cancer-care/clinical-trials/17-654

    3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
    Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.

    4. $MRK Partnership / potential Upfront Money

    5. $BMY Partnerhip / potential upfront Money

    6. 3D Med Trial Initiation (s)

    7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
    Gps MRD+ Post ACST Trial Planned

    8. GFH009 Preliminary Trial Result / ( before the final Safety reading) - CDK9 agents have proven very efficacious albeit with significant, insurmountable side affects. GFH009 will be the first to achieve a safety profile that can be useful in practice.

    GPS Phase 3 is a Registrational trial - meaning the parameters are pre approved by the fda - if their is a positive read at The Midpoint interim - and its powered to do so - the fda approval could happen in as little as 3 months from now along with a $100 share price.

    Ceo stated Fda review Q1Q2 Multibillion dollar Phase 3 Fda Review and Triple digits Just about 3 months out NOW - Shares are cheap. The primary endpoint of the REGAL study is overall survival, and the study's powered at 90%, with assumptions of a median overall survival of only 10 months inthe GPS arm, versus 5.4 months in the best available treatment arm.

    To declare statistical significance, i.e., a positive study for efficacy, one would need either a hazard ratio of less than 0.6 at interim analysis, or a hazard ratio of less than 0.675 at final analysis. ( <-- Approval at Interim)

    Interim analysis will consist of one single readout for efficacy by the independent data monitoring committee after the first 80 deaths. Both the independent data monitoring committee and the study steering committee have been established and consist of internationally renowned leukemia and biostatistical experts, including Dr. Tom Fleming, the global principle investigator; Dr. Hagop #$%$arjian, Chief of the Leukemia Department at the MD Anderson Cancer Center, and the world renowned clinical trialist in AML responsible for the successful delivery of several agents currently FDA approved for this malignancy.
  • C
    Cured
    $SLS conversation
    8 PR’s in the next 90 days - $20 per share followed by the FDA Green Light for AML $2B in Rev.
    1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
    Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    $7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations. The Joint Analysis can only improve on what is already better given Gps pristine safety profile.

    - Median Overall Survival not reached at a median follow-up of 43.1 weeks -

    2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
    https://www.mskcc.org/cancer-care/clinical-trials/17-654

    3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
    Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.

    4. $MRK Partnership / potential Upfront Money

    5. $BMY Partnerhip / potential upfront Money

    6. 3D Med Trial Initiation (s)

    7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
    Gps MRD+ Post ACST Trial Planned

    8. GFH009 Preliminary Trial Result / ( before the final Safety reading) - CDK9 agents have proven very efficacious albeit with significant, insurmountable side affects. GFH009 will be the first to achieve a safety profile that can be useful in practice.

    GPS Phase 3 is a Registrational trial - meaning the parameters are pre approved by the fda - if their is a positive read at The Midpoint interim - and its powered to do so - the fda approval could happen in as little as 3 months from now along with a $100 share price.

    Ceo stated Fda review Q1Q2 Multibillion dollar Phase 3 Fda Review and Triple digits Just about 3 months out NOW - Shares are cheap. The primary endpoint of the REGAL study is overall survival, and the study's powered at 90%, with assumptions of a median overall survival of only 10 months inthe GPS arm, versus 5.4 months in the best available treatment arm.

    To declare statistical significance, i.e., a positive study for efficacy, one would need either a hazard ratio of less than 0.6 at interim analysis, or a hazard ratio of less than 0.675 at final analysis. ( <-- Approval at Interim)

    Interim analysis will consist of one single readout for efficacy by the independent data monitoring committee after the first 80 deaths. Both the independent data monitoring committee and the study steering committee have been established and consist of internationally renowned leukemia and biostatistical experts, including Dr. Tom Fleming, the global principle investigator; Dr. Hagop #$%$arjian, Chief of the Leukemia Department at the MD Anderson Cancer Center, and the world renowned clinical trialist in AML responsible for the successful delivery of several agents currently FDA approved for this malignancy.
  • C
    Cured
    $SLS conversation
    Let’s see where we are in 90 days / 8 PR’s
    1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
    Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    NKTX added $500M on the strength of a 5 patient cohort, P1 trial. We’ll see the market considering the value of an effective safe treatment for Dying Ovarian and Mesothelioma cancer patients.

    $7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations.

    Metastatic ovarian cancer patients are at the end, cancers returned after multiple rounds of surgery, radiation chemo and platinum based chemo - run through the mill and exhausted,

    GPs Keytruda Patients have survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    This Phase 2 data will be world wide as a potential new therapy offering hope for these dying patients.
    Anecdotally, we know from prior pr, just the first patient survived for over 2 years - Avg PROC life expectancy is 9 / 10 months. 24+ months vs 9/10 --- And for those patients whose immune system respond strongly will potentially be cured like many other trials.

    The Joint Analysis can only improve on what is already better given Gps pristine safety profile.

    Anyone interested can find the List of Press Releases Here
    - Median Overall Survival not reached at a median follow-up of 43.1 weeks -

    2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
    https://www.mskcc.org/cancer-care/clinical-trials/17-654

    3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
    Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.

    4. $MRK Partnership / potential Upfront Money
    5. $BMY Partnerhip / potential upfront Money
    6. 3D Med Trial Initiation (s)
    7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
    Gps MRD+ Post ACST Trial Planned
    8. GFH009 Preliminary Trial Result / ( before the
  • C
    Cured
    $SLS conversation
    1. of 8 Known Data Hits coming within the next 90 days, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference. Prelim $MRK combination trial data from last July sent shares up to $15 ... At the Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    $7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in JUST a PHASE 1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations. The Joint Analysis can only improve on what is already better given Gps pristine safety profile.

    - Median Overall Survival not reached at a median follow-up of 43.1 weeks - for Plat Refractory Ovarian cancer patients,
  • C
    Cured
    $SLS conversation
    8 PR’s in the next 90 days followed by a FDA Green Light for AML $2B in Proj Rev.
    1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
    Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    $7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations. The Joint Analysis can only improve on what is already better given Gps pristine safety profile.

    - Median Overall Survival not reached at a median follow-up of 43.1 weeks -

    2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
    https://www.mskcc.org/cancer-care/clinical-trials/17-654

    3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
    Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.

    4. $MRK Partnership / potential Upfront Money
    5. $BMY Partnerhip / potential upfront Money
    6. 3D Med Trial Initiation (s)
    7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
    Gps MRD+ Post ACST Trial Planned
    8. GFH009 Preliminary Trial Result / ( before the final Safety reading) - CDK9 agents have proven very efficacious albeit with significant, insurmountable side affects. GFH009 will be the first to achieve a safety profile that can be useful in practice.
  • C
    Cured
    $SLS conversation
    A Great time to get in on the DIP Before the MRK and BMY results launch this baby bio. SLS traded up to $15 ahead of the last read. NKTX added $500M on the strength of a 5 patient cohort, P1 trial. We’ll see the market considering the value of an effective safe treatment for Dying Ovarian and Mesothelioma cancer patients.

    $7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations.
    Metastatic ovarian cancer patients are at the end, cancers returned after multiple rounds of surgery, radiation chemo and platinum based chemo - run through the mill and exhausted,

    GPs Keytruda Patients have survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    The Joint Analysis can only improve on what is already better given Gps pristine safety profile.

    This Phase 2 data will be heralded world wide as a potential new therapy offering hope for these dying patients.
    Anecdotally, we know from prior pr, just the first patient survived for over 2 years - Avg PROC life expectancy is 9 / 10 months. 24+ months vs 9/10 --- And for those patients whose immune system respond strongly will potentially be cured like many other trials.

    Do not get scammed by the short spammers obfuscating valuable facts.
    Joint Merck Analysis Data incoming Q4 - last year SLS traded up to 15 ahead of a PreLim readout.

    Now we are on the verge of larger, mature results - Gps is worth billions and Big Pharma will be Paying up Bigly. $MRK or $BMY May decide its time to Guppy this baby BIO

    Merck has zero agents for PROC, Keytruda is ineffective as a single agent - they need Gps.
  • C
    Cured
    $SLS conversation
    8 Known Massively Valuable catalysts in Q4 including $MRK $BMY CDK9 trial Data followed the FDA Green Light for worth billions in Q1/Q2, unless the IDMC halts the trial early For Efficacy. Jazz Paid $1.5B for CPXX when it released its P3 results. SLS shares are cheap.
  • C
    Cured
    $SLS conversation
    Market selloff, a great time to get invested, just sayin' Shares are Cheap compared to where they'll be in the next 90 days - 8 PR’s IMO $20 per share followed by a FDA Green Light for AML $2B in Proj Rev.
    1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
    Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    $7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations. The Joint Analysis can only improve on what is already better given Gps pristine safety profile.

    - Median Overall Survival not reached at a median follow-up of 43.1 weeks -

    2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
    https://www.mskcc.org/cancer-care/clinical-trials/17-654

    3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
    Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.

    4. $MRK Partnership / potential Upfront Money

    5. $BMY Partnerhip / potential upfront Money

    6. 3D Med Trial Initiation (s)

    7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
    Gps MRD+ Post ACST Trial Planned

    8. GFH009 Preliminary Trial Result / ( before the final Safety reading) - CDK9 agents have proven very efficacious albeit with significant, insurmountable side affects. GFH009 will be the first to achieve a safety profile that can be useful in practice.

    GPS Phase 3 is a Registrational trial - meaning the parameters are pre approved by the fda - if their is a positive read at The Midpoint interim - and its powered to do so - the fda approval could happen in as little as 3 months from now along with a $100 share price.

    Ceo stated Fda review Q1Q2 Multibillion dollar Phase 3 Fda Review and Triple digits Just about 3 months out NOW - Shares are cheap. The primary endpoint of the REGAL study is overall survival, and the study's powered at 90%, with assumptions of a median overall survival of only 10 months inthe GPS arm, versus 5.4 months in the best available treatment arm.

    To declare statistical significance, i.e., a positive study for efficacy, one would need either a hazard ratio of less than 0.6 at interim analysis, or a hazard ratio of less than 0.675 at final analysis. ( <-- Approval at Interim)

    Interim analysis will consist of one single readout for efficacy by the independent data monitoring committee after the first 80 deaths. Both the independent data monitoring committee and the study steering committee have been established and consist of internationally renowned leukemia and biostatistical experts, including Dr. Tom Fleming, the global principle investigator; Dr. Hagop #$%$arjian, Chief of the Leukemia Department at the MD Anderson Cancer Center, and the world renowned clinical trialist in AML responsible for the successful delivery of several agents currently FDA approved for this malignancy.
  • C
    Cured
    $SLS conversation
    News Galore in Q4: Followed by FDA Green light to $2B in rev - List of 8 Data hits below
    Share price will double quadruple or more in Q4 IMO Prior to the FDA APPROVAL GREEN LIGHT
    1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
    Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    NKTX added $500M on the strength of a 5 patient cohort, P1 trial. We’ll see the market considering the value of an effective safe treatment for Dying Ovarian and Mesothelioma cancer patients.

    $7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations.

    Metastatic ovarian cancer patients are at the end, cancers returned after multiple rounds of surgery, radiation chemo and platinum based chemo - run through the mill and exhausted,

    GPs Keytruda Patients have survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    This Phase 2 data will be world wide as a potential new therapy offering hope for these dying patients.
    Anecdotally, we know from prior pr, just the first patient survived for over 2 years - Avg PROC life expectancy is 9 / 10 months. 24+ months vs 9/10 --- And for those patients whose immune system respond strongly will potentially be cured like many other trials.

    The Joint Analysis can only improve on what is already better given Gps pristine safety profile.

    Anyone interested can find the List of Press Releases Here
    - Median Overall Survival not reached at a median follow-up of 43.1 weeks -

    2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
    https://www.mskcc.org/cancer-care/clinical-trials/17-654

    3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
    Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.

    4. $MRK Partnership / potential Upfront Money
    5. $BMY Partnerhip / potential upfront Money
    6. 3D Med Trial Initiation (s)
    7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
    Gps MRD+ Post ACST Trial Planned
    8. GFH009 Preliminary Trial Result / ( before the FINAL Safety ) + New Trial Initiation(s)
    REGAL Enrollment Completion / Jan - This catalyst is worth $500M in MC value.
  • G
    Gary
    Come on MRK + SGEN, everyone on Wallstreet has blessed this deal as being needed, smart and strategic. MRK stock will also go up on the announcement. Both your stocks will be in the doldrums for years without this deal. Do it over the weekend.
  • J
    Joe
    $SLS conversation
    PT $75 CEO set the table for shareholders Sept Gps symposium starts the run, 4/5 Q4 Massive data Hits $mrk $bmy followed by FDA Green Light in AML.
  • C
    Cured
    $SLS conversation
    $MRK $BMY CdK9 Final - 4 or 5 Massive trial readouts from now til the end of the year followed by GPS FDA APPROVAL Q1/2. The GPS Phase 3 is FDA REGISTRATIONAL Trial - Registrational process is Straightforward: Pre Authorized FDA approval, IF - 10 months of OS, a HR.06 and its achieved statistical efficacy for approval. Its the only requirement for FDA Approval. Its automatic. - A truly Binary Billion dollar Readout in 1 or 2 quarters.
  • C
    Cured
    $SLS conversation
    Let's see Where we R in 90 days - List of 8 Data hits followed by a FDA Green light for the first Immunotherapy to treat AML patients --- Share price will double quadruple or more in Q4 IMO
    1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
    Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    NKTX added $500M on the strength of a 5 patient cohort, P1 trial. We’ll see the market considering the value of an effective safe treatment for Dying Ovarian and Mesothelioma cancer patients.

    $7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations.

    Metastatic ovarian cancer patients are at the end, cancers returned after multiple rounds of surgery, radiation chemo and platinum based chemo - run through the mill and exhausted,

    GPs Keytruda Patients have survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    This Phase 2 data will be world wide as a potential new therapy offering hope for these dying patients.
    Anecdotally, we know from prior pr, just the first patient survived for over 2 years - Avg PROC life expectancy is 9 / 10 months. 24+ months vs 9/10 --- And for those patients whose immune system respond strongly will potentially be cured like many other trials.

    The Joint Analysis can only improve on what is already better given Gps pristine safety profile.
    - Median Overall Survival not reached at a median follow-up of 43.1 weeks -

    2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.

    https://www.mskcc.org/cancer-care/clinical-trials/17-654

    3. CDK9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
    Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.

    4. $MRK Partnership / potential Upfront Money

    5. $BMY Partnerhip / potential upfront Money

    6. 3D Med Trial Initiation (s)

    7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
    Gps MRD+ Post ACST Trial Planned

    8. GFH009 Preliminary Trial Result / ( before the FINAL Safety ) + New Trial Initiation(s)

    REGAL Enrollment Completion / Jan - This catalyst is worth $500M in MC value.
  • S
    Stanley
    Hope MRK is paying attention what overpaying for an acquistion could do to their share price. Check out the ADBE 20 billion deal on the table and see how much they have lost in share price in just 2 days. MRK if planning on paying 40 billion for SGEN (currrently on hold) for a company who has never made a profit in 25 years. Insiders have robbed it blind. MRK bought shares of SGEN for $200.00 and now the stock is below 140. There are better deals out there is they want to expand in the cancer sector.
  • C
    Cured
    $SLS conversation
    Gps symposium re Commercialization - Expectations- Compounded Evidence of EFFICACY - For funds who have determined approval is likely, a Definitive scope of market with drug pricing could cause some serious investment. - 200M in annual rev is worth $2b to big pharma, all day.
    Expectations:
    - The 10Q update, that the Phase 3 timeline is on track, set the clock ticking for New and Accumulating Institutional investors.
    - More $$ Paying attention and getting more interested, fullest definition of the term 'interested' applies.

    - no material data, per sec regs
    - CCo

    - Analysts appreciate clarity for investment return analysis

    - Gps combination w Opdivo:
    - $MRK Joint analysis Gps combination w Keytruda for Pr/rOC ovarian cancer patients.

    - EAP - Gps investigators, the Chair of MD Anderson, sees 34 month old open label trial and has requested expanded access to Gps for ASCT patients.
    Expanding the label potential to 50% of all AML patients MRD, Cr1
    - 5X Cr2
  • S
    Stanley
    Just wait and see what happens to Merck's stock price if they over pay 40 billion for SGEN. ADBE over paid 20 billion for their latest acquisition and it totally tanked the stock. Take a look at ADBE's share price the day it was announced. SGEN has never made a profit after 25 years as the insiders have been robbing it blind taking millions out from stock options given to them for next to nothing. MRK paid $200.00 a share for millions in SGEN stock only to watch it dive to $140.
  • C
    Cured
    $SLS conversation
    Let’s see where we are in 90 days / 8 PR’s followed by a FDA Green Light For Aml. 1. Ceo posted, Gps Keytruda joint analysis Final Results at an Upcoming Medical Conference
    Prelim MRK combination trial data from last July sent shares up to $15 ... Final Data / A joint analysis conducted with Merck ' is now imminently due. Last update, GPs Keytruda Patients had survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    NKTX added $500M on the strength of a 5 patient cohort, P1 trial. We’ll see the market considering the value of an effective safe treatment for Dying Ovarian and Mesothelioma cancer patients.

    $7 to $20 in a day $NKTX is a good example of the Markets reaction to a potential meaningful therapy for End Stage Cancer patients who have exhausted all options, + $500M in MC based on a 5 patient cohort in a P1 - because these patients were dying, had no other options, exactly the same kind of patients in BOTH of the GPS combinations.

    Metastatic ovarian cancer patients are at the end, cancers returned after multiple rounds of surgery, radiation chemo and platinum based chemo - run through the mill and exhausted,

    GPs Keytruda Patients have survived already for as long as the Current best available therapy and "median Overall Survival has not yet been reached".

    This Phase 2 data will be world wide as a potential new therapy offering hope for these dying patients.
    Anecdotally, we know from prior pr, just the first patient survived for over 2 years - Avg PROC life expectancy is 9 / 10 months. 24+ months vs 9/10 --- And for those patients whose immune system respond strongly will potentially be cured like many other trials.

    The Joint Analysis can only improve on what is already better given Gps pristine safety profile.

    Anyone interested can find the List of Press Releases Here
    - Median Overall Survival not reached at a median follow-up of 43.1 weeks -

    2. $bmy Gps + Opdivo Mature data for Advanced Mesothelioma Patients. Earlier Data has been the most promising of any treatment in trial for this significant unmet need. Opdivo + Yervoy, extended OS 3 months for front line patients and rec;d FDA approval. Gps + opdivo extended OS 4 months for second, 3rd and 4th line patients, So far, in a much sicker patient setting - without the significant black box side affects typically associated with advanced trial agents.
    https://www.mskcc.org/cancer-care/clinical-trials/17-654

    3. cdk9 agents have a strong track record of Efficacy in multiple indications. GFH 009 is the first Highly selective, on target, less sa's for AML front line and several other indications. A FINAL Safety Analysis is incoming in Q4. A Truly Safe CdK9 Agent is a Huge Deal. Can't stress enough.
    Keep in mind Dr. Kadia at MD A is running point for SLSs P3, and ALSO coincidentally for Genfleet.

    4. $MRK Partnership / potential Upfront Money
    5. $BMY Partnerhip / potential upfront Money
    6. 3D Med Trial Initiation (s)
    7. License Money from the $191M milestones remaining - 2 Separate Milestones in Q4 totaling appx. $12.5M
    Gps MRD+ Post ACST Trial Planned
    8. GFH009 Preliminary Trial Result / ( before the final Safety reading)
  • C
    Cured
    $SLS conversation
    Gps symposium re Commercialization - Expectations- Compounded Evidence of EFFICACY - For funds who have determined approval is likely, a Definitive scope of market with drug pricing could cause some serious investment. - 200M in annual rev is worth $2b to big pharma, all day.
    Expectations:
    - The 10Q update, that the Phase 3 timeline is on track, set the clock ticking for New and Accumulating Institutional investors.
    - More $$ Paying attention and getting more interested, fullest definition of the term 'interested' applies.

    - no material data, per sec regs
    - CCo

    - Analysts appreciate clarity for investment return analysis

    - Gps combination w Opdivo:
    - $MRK Joint analysis Gps combination w Keytruda for Pr/rOC ovarian cancer patients.

    - EAP - Gps investigators, the Chair of MD Anderson, sees 34 month old open label trial and has requested expanded access to Gps for ASCT patients.
    Expanding the label potential to 50% of all AML patients MRD, Cr1
    - 5X Cr2

    Upcoming Investor Symposium

    The Company will host a virtual investor symposium on Thursday, September 15, 2022, from 1:00 p.m. to 2:00 p.m. ET. The event will focus on the Company’s lead clinical asset, GPS, including the potential commercial opportunity for GPS in AML patients.

    Event: Galinpepimut-S Update Call
    Date: Thursday, September 15, 2022
    Time: 1:00 p.m. Eastern Time
    Live Call: +1-877-407-9716 (U.S. Toll Free) or +1-201-493-6779 (International)
    Fund Analysts will have sharp pencils at the Gps symposium re commercialization: Sept 15.
    - Currently Cantor Fitz Estimates GPs rev $200M for Cr2 + and growing to include CR1, a market 5 x the size. identical to the Cpxx revenue est prior to its buyout.

    - Funds already invested are paying attention will be listening closely for the company plans to cash in on the potential.
    - a fact SLS shares will instantly triple or quadruple : If SLS does a license deal with $bmy $mrk for ovarian cancer or mesothelioma ( two trial readouts imminent )

    $Jazz paid $1.5B for CPXX right when it Released P3 data --> " Celator previously projected sales between $200 million and $270 million in the U.S. and European markets; although sales could top out between $690 million and $780 million if Vyxeos is approved to treat AML patient populations outside of the subset used in the Phase-3 study." Wall St Journal article