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Avadel Pharmaceuticals plc (AVDL)

NasdaqGM - NasdaqGM Real-time price. Currency in USD
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8.12+0.23 (+2.92%)
At close: 4:00PM EDT
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  • A
    Andras
    It's understood that FT218 will be much more convenient than Xyrem (putting other aspects aside for now). Although both are oral, having to wake up during the night to take 2nd dose of X just to get a better sleep is just insane.
    Let me give you an ongoing example, that fuels my bullish opinion on AVDL. I'm also invested in BCRX. For HAE, the current market leader is Takhzyro, which is a self administered injection, just like every other available treatment for this condition. BCRX got approval of Orladeyo worldwide in the past 1 year and launched recently, having 1Q of revenue already - and they blasted off the roof, exceeding all analyst expectation. The key: Orladeyo is 1x day oral pill, much more convenient than injections.
    I don't want to advertise BCRX, but there's an even bigger prize ahed for them, against PNH, they're developing a pill, while available treatments are administered as infusions in hospital, and they cost 500k/year. No brainer to switch (if approved).
    So all I'm trying to say: hard to estimate the convenience factor. At least in case and Orladeyo, the market underestimated it, and BCRX had a better than expected ramp up of sales in the 1st Q. I hope we will experience the same with AVDL.
  • J
    John
    You can never be 100% of approval with the FDA until you get the approval… but things are looking good. Will be interesting to see if Divis mentions having started labeling talks in his presentation tomorrow. That doesn’t guarantee approval, but it would be another good sign that could boost the odds to 95%+ that we get approved.
  • D
    Daren
    Why doesn't Jazz just buy this company for $1 Billion and save themselves Billions in lost sales when this drug hits the market. They already have a build in sales force that could easily transfer to the new drug.
  • K
    King W
    Avadel Recognizes World Narcolepsy Day and Announces New Data Presentations from Pivotal Phase 3 REST-ON Trial of FT218 at Upcoming Conference

    https://investors.avadel.com/news-releases/news-release-details/avadel-recognizes-world-narcolepsy-day-and-announces-new-data
  • O
    Oblio
    $1.8B SO market that the Tesla will easily steal well over 50% from the buggy whip company and we still sit with a sub $500M MC. If 218 does so poorly to only do $500M in sales then at MC valuation of 3 to 5 times sales puts us around $25 at the low end of the value range.

    What's WS waiting on? Still afraid of Brucie's frivolous lawsuit? Uncertain if Divis and Co will be able to sell Teslas at the same price of buggy whips? Makes very little sense to me.
  • O
    Oblio
    For a small company we sure have a lots of analysts following the stock:

    Craig Hallum
    Robin Garner
    H.C. Wainwright & Co. LLC
    Oren Livnat
    ISS-EVA
    Casey Lea
    Jefferies
    Christopher Howerton
    Ladenburg Thalmann & Co. Inc.
    Matthew L. Kaplan
    LifeSci Capital
    David Sherman
    Oppenheimer & Co. Inc.
    Francois Brisebois
    Piper Sandler & Co.
    David Amsellem
    Stifel
    Paul Matteis
    SVB Leerink
    Marc Goodman
  • P
    Petr
    How is it possible that Axsome may enroll “just” approx 90 patients? When Avadel had to do more? And the treatment is only for 5 weeks?
  • M
    Mathew Fuji
    Exactly 4 weeks left to PDUFA date. Keeping fingers crossed as always in humility!! GLTALs!!!
  • L
    Larry
    Lol mrbignews, got the wrong board, we talked about the caught syrop multiple times.
  • A
    A16
    30 days….to company notification…tick…tock…tick…tock…..so hard to feign disinterest….soon will be impossible…. All imho
  • M
    Mathew Fuji
    Happy Labor Day folks. Those familiar with the review process would know that AVDL at this point has passed two major events. One is the mid-cycle review meeting. This is basically and internal discussion that FDA has with all reviewing divisions and they communicate mostly by phone with the sponsor of any issues. Then sometime before the PDUFA they have a f2f or telecon late-stage review meeting with the sponsor. This is another opportunity for the sponsor to understand and gauge the direction the division is taking. Generally most outstanding deficiencies are discussed and we get an opportunity to present our case strongly at this meeting. All sections including CMC would be covered. There may also be a final labelling discussion which also should have already happened or is happening any day now. If anyone took the pain to attend FDAs public WebEx highlighting the modified approaches they have been using for the PAI of offshore manufacturing sites you will know how they are handling that.
    So we are now getting closer to the one month to PDUFA date. Divis as I can see has stepped up the investors outreach and marketing team hiring process. The company has now no relationship to its revenue potential. It’s now only held by those who trust it has a path forward to market. Actual revenue-related valuation should happen as clarity emerges at PDUFA and then quashing of the expected JAZZ PI.
    We already know what Jazz has and how extremely tough the barrier is to get a TRO/PI.
    So with Grace all invested now will prevail and be happy!!!!
  • B
    Bernard
    Looks like Glass transferred (not sold) 42k shares to a trust.
    "On September 16, 2021, the reporting person transferred 42,000 options to a family trust of which the reporting person is trustee. The reporting person and members of his immediate family are the sole beneficiaries of the trust."
    I wonder if this is may be to reduce tax burden when it triples or something?
  • F
    Fosco
    At this point (1 month prior PDUFA) there is no PIV request from the FDA
    The investment community who had doubts about this should begin to wake up
    All the other aspects seem positive too. Divis is 1000% focused
    I think prior this 10/15 date, some should realize the potential it has. So far it's been stable
    GL all
    Fosco
  • B
    Bernard
    @Larry - thanks! Here is the sleep study reference and Stanford University article that highlights significance.
    ON-SXB (FT-218) Study: https://academic.oup.com/sleep/advance-article/doi/10.1093/sleep/zsab200/6343406#300066786

    https://med.stanford.edu/news/all-news/2021/09/narcolepsy-drug.html:
    "Waking in the middle of the night to take the medication can be highly disruptive, especially considering that patients typically already experience fragmented sleep and poor sleep quality."
    "A study in Europe showed that 27% of patients with narcolepsy did not take sodium oxybate on the recommended time schedule. When patients need to take medications more than once daily, they tend to miss doses: This problem has been seen with other conditions, including depression, schizophrenia, epilepsy, Type 2 diabetes, cardiovascular disease, chronic obstructive pulmonary disease and HIV."
  • L
    Larry
    Fascinating the next options are on 10/15, common FDA don't make us wait, let's get ft218 approved, the patients need it.
  • L
    Larry
    As Marc corrected me yesterday, the presentation is must watch for everyone who is invested here, except anphony, he won't be able to process the data.
    My boy Gregory answered a lot of important questions, inspection, litigation schedule, discussions with payers, so if you care about your investment go watch the webcast.
  • P
    Patc
    somebody wanted out of JAZZ in a big way. 100,000 shs traded at 130 going into the close, (a new one year low) Wonder where that 13 mil will find a home ?
  • K
    King W
    Someone was eager to buy some Avadel shares thuis morning

    10:58:57 - $ 8.00 - 300,000
  • P
    Petr
    I read on twitter some observatiom about slow onset of that approved product of Jazz that they bought with GW. They have capsules/tablets? while there are drugs, probably not approved yet (Tetra pharma?) that have quick effect after inhaling.

    May this be another reason why Jazz may reconsider shelling out much more for Avadel’s FT-218 if it is approved and free to operate?

    Just my opinion.
  • L
    Larry
    Another stellar presentation, really good answer on the upcoming pdufa and litigation schedule, go watch it, don't be like anphony.