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Avadel Pharmaceuticals plc (AVDL)

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7.54-0.21 (-2.71%)
As of 11:13AM EDT. Market open.
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  • L
    Larry
    Is impossible to not share this one, everyone should find the full transcript of recent bofa report 06/11

    Jason Gerberry: Yep. Okay. So it sounds like- just to sort of, kind of wrap it up on this topic, it sounds like low odds of getting 30-month stay, low odds of getting a PI.
    Shashank Upadhye: Jason zero odds on 30-month stay. We have to keep repeating it.
  • P
    Patc
    Larry, was this in the 10k or the annual report, I can't find it in the 10k
    thx

    Jazz’s words in a 2015 10-K which states Jazz is “also
    pursuing other activities related to the potential development of options for
    narcolepsy patients that would provide clinically meaningful improvements
    compared to Xyrem, including once-nightly dosing.” Even Jazz
    acknowledges here the unmet need for a once-nightly formulation
  • L
    Larry
    Granting of Preliminary Injunction is Unlikely. A temporary injunction is
    highly unlikely due to the established unmet need for FT218, differentiating it
    from a simple convenience play. When a new drug addresses an unmet need,
    Courts are typically not inclined to block access to the drug and thus deny
    patients its clinical benefits. Avadel greatly weakens Jazz’s footing on this
    argument by pointing to Jazz’s own once-nightly formulation pursuit,
    reminding the Court of Jazz’s words in a 2015 10-K which states Jazz is “also
    pursuing other activities related to the potential development of options for
    narcolepsy patients that would provide clinically meaningful improvements
    compared to Xyrem, including once-nightly dosing.” Even Jazz
    acknowledges here the unmet need for a once-nightly formulation.
  • M
    Mathew Fuji
    So Larry are you saying …. Our group of expert retail sue diligence folks were right all along???
    Kudos to Trin DP and others who contributed heavily!!!
  • L
    Larry
    Jason Gerberry: How about on PI? How about on PI?
    Shashank Upadhye: On the PI, again, not knowing exactly what the Avadel product is knowing that Avadel is well aware of it, knowing that Avadel probably has all the opinions that they need on potential ability and experts. I think that the PI will be denied and therefore that will give Avadel the ability to launch from a court perspective, whether they choose to launch or not obviously is a commercial decision when they read the decision on the PI, how strong it is.
    Jason Gerberry: If they were found to infringe the patent, do you think that PI has a chance or no?
    Shashank Upadhye: So is your question if in the factorial test, if the judge says, I think there was an infringement of patents, do you think the judge will then just basically say, okay, PI granted? Is that what you were asking?
  • M
    Mathew Fuji
    Don’t say you did not get an opportunity to add OK. Use anything they present!!!
    Derisk your money by averaging down. Hopefully you will hear some great news far more reinforcement than the secondary data readout because it involves Xyrem switch patients!!!! So hold strong and add folks!!! Don’t fall for the market gimmicks here or elsewhere. Ultimately NEVER put even a dime where you really cannot put your foot down and call the market bluffs!!!
    If you reach that level of integrity in your investment decisions then the market moves will not matter unless you are in a buying mode!!!
    Key item TK remember: Many of you are far more intelligent and capable of due diligence than these analysts at firms who often are limited and biased.
    My PT for AVDL was $17.5 but has gone up considerably since now I am focused NOT on a BO but the patients!!!! If my product can bring a good nights sleep (better night sleep) to a suffering patient then my money is well invested. SO FAR MY INVESTIGATIONS ARE PROVING ME RIGHT!!!!
    More to come hopefully soon 😉
    Enjoy the weekend folks!!
  • T
    Trin
    The sooner patient switch from xyrem to xywav, the faster AG will enter. When AG enter, in the presence of ft218, it will have to reduce the price in order to compete with ft218. if AG's price reduction still has no effect on ft218 sales, then right away that will prove a moat for ft218 in 2025 when multisource generics will come. This mean investors will value Avadel is a much more bond like manner with stable cash flow each year and low discount rate. I personally see Jazz is unintentionally giving value to Avadel's investors.

    So please jazz, convert your patient to use xywav as fast as possible, i want avadel to be proven as soon as possible that generics have no impact, that way the valuation will be much higher.

    Unless we are granted orphan drug exclusivity..

    Let me know what you guys think
  • M
    Mathew Fuji
    Around 300K increase in short interest between 05/14 through 05/28. Insignificant total open short positions (<9% of total) but still worth noting the volume and $$ that’s being used to play. Low volume daily trades make it important to note that as we move closer to the PDUFA
  • P
    Patc
    Don't know if there is a link to the JAZZ KOL call, but here is part of their report

    Avadel recent Answer alleges inventor-ship issue w/ JAZZ formulation IP: On 6/3, Avadel filed its Answer, effectively responding to Jazz’s infringement allegations. While the expert didn’t express a view on the merits of Avadel’s argument that JAZZ’s form patents may suffer from lack of inventor-ship, he noted that a PI hearing could (based on his experience) serve as a mini-trial that adjudicates such issues. However, since it is still unknown whether Avadel’s FT-218 includes key formulation polymers described in JAZZ’s formulation patents, the expert believes the case could easily swing in Avadel’s favor if their formulation incorporates different polymers; Avadel’s ‘062 patent does mention other polymers, which opens the possibility its commercial product does in fact use a different polymer. Last, if Jazz can show FT-218 does infringe its formulations patents (with no apparent validity issues), the expert believes Jazz may be able to secure a PI but the expert was cautious on Jazz satisfying the other elements of the PI legal test, including proving irreparable harm.

    anyone who wants full report email me at vigaits

    @

    aol
  • T
    Trin
    I made my own summary of Avadel's response, i hope it may be some use:

    For patent 963, Avadel explained why 963 cannot be included in orange-book listed patent, and hence cant be used for permanent injunction [page 18, 31]. It did not explain why ft218 didn't infringe it, I think that's because it is baseless (they haven't seen Avadel's REMS) so Avadel just denied it. Although Avadel did referred to 2018's litigation with amneal that claim 24, 26, 27 of 963 patent is invalid, Avadel has not shown why it did not infringe independent claim 1 and 23 [page 17].

    For patent 488, 885, 956, 931 Avadel went at it with three arguments. First, Avadel explained that the claim related to methacrylate has not been shown in the specification, and hence are granted a priority date of July 2018, which is later than ft218's patent, so no infringement [page 37 paragraph 11, page 43]. Second, Avadel explained that Jazz's invention is limited to a compressed tablet only [page 37 paragraph 11]. Third, Avadel shows that upon ft218's patent publication on jan 2018, Jazz removes all details such as “compressed tablet controlled release core”, “providing a time dependent release”, “pore former,” out and include a claim about methacrylate specifically in lieu of Avadel's patent [page 37 paragraph 12].

    My view

    I think the explanation is very clear and leaves no room for further investigation to not invalidate patent 488, 885, 956, 931. Patent 963 is just baseless, and with ft218 being a 505b2 as well. I personally see this as an overkill, why did bruce set the volleyball such a way only to be smashed into his own face?

    References

    From page 17: "Defendants admit that the remaining claims of the ’963 patent have not yet expired, although several of its claims and all claims of the six related Jazz patents that purportedly cover Jazz’s REMS process were invalidated by the Patent Trial and Appeals Board in Inter Partes Reviews. Those invalidity decisions were affirmed by the Federal Circuit. Jazz Pharms., Inc. v. Amneal Pharms., LLC, 895 F.3d 1347 (Fed. Cir. 2018)."

    From page 18: “Defendants admit that Jazz brought a claim of infringement of the ’963 patent under 35 U.S.C. § 271(e)(2)(A). Defendants deny any and all remaining allegations and/or legal conclusions set forth in Paragraph 49, because, inter alia, 35 U.S.C. § 271(e)(2)(A) applies solely to NDAs for “a drug claimed in a patent or the use of which is claimed in a patent.” The ’963 patent covers neither a drug nor a method of using a drug”

    From page 31: “Paragraphs (A)-(K) set forth Jazz’s prayer for relief to which no response is required. To the extent that responses to these paragraphs are required, Defendants deny any allegations set forth therein and deny that Jazz is entitled to any relief, including a permanent injunction pursuant to 35 U.S.C. § 271(e)(4)(B) as, inter alia, this action does not implicate that statute, the ’963 patent was not appropriately listed in the Orange Book, and Jazz otherwise would not be entitled to relief under said provision.”

    From page 37 paragraph 11: “Further, the Jazz ’369 application had no claims or teachings of dissolution testing or the release profiles resulting from such testing of formulations containing methacrylic acid-methyl methacrylate co-polymers in deionized water using apparatus 2 at a temperature of 37°C and a paddle speed of 50 rpm, as described in the ’062 application. After the ’062 application was published, Jazz let its ’369 application become abandoned on November 2, 2018”

    From page 37 paragraph 11: "Claim 1 of the Jazz ’369 application was originally directed to “a controlled release dosage form for oral administration,” but the applicant narrowed claim 1 first to a “compressed tablet” and later to include a “compressed tablet controlled release core,” in response to rejections finding that claim 1 was obvious over a prior art patent application to Liang et al."

    From page 37 paragraph 12: "Jazz canceled all 108 original claims that generally recited the four components described supra – namely a “compressed tablet” controlled release dosage form, comprising at least one polymer comprising ethylcellulose, at least one polymeric “pore former,” and reciting “providing a time dependent release” measuring release of the drug from time of administration. In stark contrast to its prior set of claims, Jazz deleted each of those four attributes, and replaced them with claims directed to a generic formulation (rather than a compressed tablet) comprising specifically methacrylic acid-methyl methacrylate co-polymers (rather than one polymer comprising ethylcellulose and at least one polymeric “pore former”), and recited a specific dissolution profile defined by tests performed “in a dissolution apparatus 2 in deionized water at a temperature of 37°C and a paddle speed of 50 rpm” (rather than reciting attributes following administration)."

    From page 43: “Alternatively, because the claims of the ’488 pate
  • M
    Mathew Fuji
    By the way- Just to engage while we wait for the PDUFA and subsequent launch here, any other interesting stocks you guys concurrently invested in or seriously investigating?
    I see folks like Ouch in some but curious to know what others are upto. Forget AVDL for some time. Let it mature through the regulatory pathway and get into revenue stage.
    Unless you had something pressing to discuss it would be interesting to see the other interests if you are ok sharing 😊
  • M
    Mathew Fuji
    I think there is a desperate attempt by the now anonymous handle to bring some irritation to this board? Sodium intake and dehydration? This is a very immature argument that has been debunked by KOLs (physicians). Remember that daily sodium intake can be easily controlled. All the patients need to do is to skip the pack of lays or fries or anything else they consume with excess salt in there. It’s a very simply nutritional management system. Patients have been doing this for two decades now including folks who already have hypertension and narcolepsy concomitantly. Peer review publications have analyzed effect of decades long Xyrem intake on HT and CV. In addition we have interacted with numerous major KOLs (actual prescribers) who have categorically denied the concerns try have or the importance they place on sodium content of a narcolepsy therapeutic. Xywav had to be offered for free for months before folks decided to shift.
    Now with regards to high salt at bedtime. It is likely you will sweat and feel thirsty so they would have a protocol similar to what was used for Xyrem about water consumption.
    I can tell you that based on first hand information directly from restore trial participants- They DO NOT HAVE ANY ISSUE getting up for a pee break and go back to sleep (deep) after that.
    More significant information on the totality of benefit that FT218 brings will be presented at the sleep conference next week.
    World renowned sleep neurologists will be presenting the information.

    The boat is nearing the shore. Throwing tiny pebbles at it will not work. It is bigger and stronger than it looks from the shore. In fact…… It is a big one!!!!!

    We encourage any concerns folks have to be discussed here. But let me assure you that sodium isn’t a concern at all. And this is directly from physicians and patients!!! It simply isn’t. End of story.

    FT218 market is way bigger than what many here think and that’s a great thing. Remain humble and underdog till the day we launch.
    Remember these
    1- Reston Ph3 was projected NEVER to enroll fully and AVDL to bankrupt
    2- Reston Ph3 was projected NEVER to achieve primary clinical endpoints
    3- Avadel was NEVER supposed to be with $213M cash in hand!!!!
    4- FT218 was NEVER projected to be more clinically meaningful that the 2X
    5- Para 4 certification and 30-month review block was guaranteed by sell side analysts?
    6- Jazz was supposed to have a strong legal point of attack?

    Only the PDUFA and launch remains hahaha 🤣 With a bit of patience and Grace we will get this important therapeutic to many (30-50% existing and ALL NEW) SO eligible patients!!!!!!
    Price target will move to $35+ for many here as time goes by. We are in the $8s now 😉
  • R
    Russell
    Might be old news but I just saw this post on twitter.

    Avadel Pharmaceuticals has bolstered its leadership team in advance of the anticipated regulatory approval of FT218, a narcolepsy drug, later this year. The additions include VP, sales Jeff Cruikshank, VP, marketing and new product strategy Denise Strauss and VP, people and culture Angela Woods. “We believe once-nightly FT218 has the potential to truly impact the way people with narcolepsy are able to live their lives. As we accelerate our launch preparations and commercialization strategy ahead of the anticipated U.S. regulatory approval, we are thrilled to welcome these three biopharma leaders to our growing team,” said Avadel CEO Greg Divis in a statement.
  • A
    Andras
    I bought 1000 shares today. Total is 8000, below $4 average. Wanted to do this final purchase before the new data reveal, though such good news usually don't move the share price for AVDL. Anyway, I'm lomg for 3 years, only buying, never selling, and I can wait a few more months to see how this plays out. Payday is coming folks!
  • A
    Andy
    Hello Avadel family. New data just released. I only have 2 minutes to read before jumping into a meeting but it looks like:

    - FT218 works well for both NT1 and NT2
    - FT218 works well for both patients using stimulants & not using stimulants
    - Cherry on the cake, FT218 makes patients lose a little bit of weight

    Is it correct? Do you see other points? Thanks
  • a
    alex
    Ok I just visited the AASK sleep conference page. Strong presence for AVDL. I’m really glad they are obvious to any visitor not like last year. Data look awesome.
  • M
    Mathew Fuji
    May have been JefMN or somebody else that asked the rationale for Wakix ad FT218 synergy. Well in a way I was wrong but in a positive way. Take a look at the post-hoc analysis abstract comparing efficacy between patients who were on some daytime stimulants vs those that didn’t use any daytime stimulants!! If there isn’t much additional benefits for EDS by adding a stimulant it is possible FT218 could be a standalone for a lot of folks. I think it all goes down to catching the patients before getting habituated to the disruptive dosing regimen is available SO options. Get the patients directly onto FT218 and they develop a nice sleep routine around appropriate dosage of FT218 and it could be way less than Xyw if started early on FT218!!!
    My 2 cents
  • A
    A16
    Do you hear that? I don’t hear that Jazz in the middle of the night after 4 hours. That’s the null sound of sleeping through the night. Goodbye Jazz effect... All IMHO
  • a
    alex
    So guys. Yesterday I was evaluating my holdings and looked deeper into here. Even by my standards , I should trim but I told myself. Waited that long, witnessed ups (very little) and downs (so many) but we always recover and now we are on the last leg. Will not make any moves unless something drastically change. I just hope the options market picks up a little but with no interest or volume it’s a waste. So enjoy the summer
  • A
    A16
    125 days....tick............tock....so hard to feign disinterest soon will be impossible....all IMHO