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Avadel Pharmaceuticals plc (AVDL)

NasdaqGM - NasdaqGM Real Time Price. Currency in USD
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8.44-0.02 (-0.30%)
At close: 4:00PM EDT
8.40 -0.04 (-0.41%)
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  • O
    Ouch
    Ouch may decide to buy some cases of the finest Napa wine in advance anyway, since supply chains are cutting off his supplies(check "the drudge report" right now for wine supply chain shortage articles corroboration).

    AVDL is an investment, not a binary event trade.....FT-218 has the potential to entirely disrupt a currently already existing nearly ~$2B sodium oxybate market space($1.8B/Y to be exact). This is potentially a 9.0 earthquake kind of disruption, potentially shattering the current, IMO, soon to be obsolete 20-year old twice-a-night S.O. therapy...

    Oh, how I absolutely LOVE this situation in the making and do feel as if AVDL(NOT JAZZ) is in the catbird's seat!!!
  • O
    Oblio
    It's just a waiting game now for the FDA to give that final stamp of approval and assign ODE. I'm thinking no longer than 4 weeks after Friday's pdufa.

    Very much doubt even the shorter speculators jumping in at +$10 before the pdufa are gonna take +15% losses if they have done their DD unless it was a small number of shares and they need the $.
  • A
    A16
    Well a few things from the PACER - looks like a submission yesterday was sealed (presumably Jazz position on PI - not sure why that was sealed). And then today it looks like the AVDL request for tossing out the Jazz REMS orange book was denied…at least for now….as it does look like the door was left open to revisit during later phase in claim construction maybe???…. As a big disclaimer I am no legal expert but would be interested to hear interpretations on it . All IMHO.
  • M
    Mathew Fuji
    Please don’t forget or ignore the significance of the filing that we saw yesterday regarding DDI OK. Today’s update is great but don’t ignore yesterday’s. One major issue with Xyrem and Xywav is the extreme spike and related serious mental confusion and almost horrible experiences patients go through if they don’t time the 2nd dose timely. Few folks that are on Xy have personally told me what they go through. Well NONE OF THAT with FT218!!! These folks sleep more consistently, wake up way way more alert and also the afternoon alertness is really significantly different which is a major benefit for driving.

    For younger folks living in college dorms with others can you imagine the disruption with the nightly alarm and the safety issues with handling insecure doses left out??
  • J
    John
    The key to understanding what the FDA news on Friday might mean is to consider all the other things the FDA could have done but didn’t do. The FDA could have issued a CRL, but didn’t. The FDA could have issued a deficiencies that preclude labeling discussions but didn’t. The FDA could have issued a tentative approval with the final approval conditioned on determining the ODE status of FT218 vis a vie Xywav, but didn’t. In the face of these three things not having happened, I conclude that the FDA just needed more time to finalize its labeling talks with AVDL. I presume from what we know this will take 2-4 weeks. Odds of a favorable outcome are very high… higher than they were before Friday’s news in fact as these developments are incrementally positive to odds of ultimate approval.
  • M
    Mathew Fuji
    I am with the balanced investors here (Petre, Kirk and JeffMN): So this is a call to dear friends like Ouch and Oblio to stay grounded TILL we see this through full approval and ODE. I totally ignore the lawsuit (both for PI and other) as every long here KNOWS (not guessing) for sure that they DO NOT have even have a 1% chance to prevail. Challenge us if anyone has questions on that.
    So friends in humility we wait!!! GBALs!!
  • F
    Fosco
    - No CRL
    - No PAI
    - No additional questions
    - No negative points raised
    - No date in October but also no 3 or 6 Months delay announced

    All this is implicitly positive

    Market can see a delay as negative but the only negative in reality is that we need to wait more,

    The positive is that the probability of success has raised, I would say from 90% to 95%

    JMO of course
  • P
    Patc
    All 10 analysts following AVDL are out with new reports today. They all keep their buy or outperform. 3 lowered their price target by 1, and Oppenheimer went from 19 to 16. Price targets range from 14 to 23 Average being in the 17-18 range.
  • M
    Mathew Fuji
    Folks this is a game changer and JAZZ knows it. Even the fictional novel by Jazz speaks to it.
    For those that have followed AVDL it has been really a thrill all along. Like reading a thrill packed novel. The script took you through really really really traumatic moments but then the sun shines through.
    I have to admit - I had a toast planned for Monday but hopefully I will be able to do one but maybe slightly differently.
    The delay notification is unfortunate but read through carefully and compare with other events in 2021. Hopefully our Sherlockhomes Petre will enlighten us with a comparative analysis of such events. What drove the delays (reasons cited) and timelines. The most important factor is not the time but the reason!! So do t lose sight of that.
    This is a therapeutic improvement with significant clinical superiority over existing SO options (both low and high sodium). FDA have surveyed the patients, caregiver (including family) and physicians directly. It was a long day of direct audience survey Q&A session. Clearly the issues with twice nightly both for patients and the caregivers were brought out. Add to that Avadels NDA is packed with hard data supporting the clinical benefit of once at bedtime and data-based evidence of the dangers with the twice nightly formulation.
    So don’t lose sight of all of that because of this event.
    The therapeutic will steal most if not all of JAZZs SO business!!
  • M
    Mathew Fuji
    As Cedric posted UCB got notified but specifically informed that PAI pending which is typically what happens.
    Now we do know that they were in labelling discussions and always back and forth happens during that stage. As I had indicated before this is a multi division process. So after each modification there is a process across groups. So I personally am very much confident that they WILL NOT be ascribed a new PDUFA of say 3-month but it is going to be as soon as early November
    This is my assessment of the situation. For very obvious reasons short sellers will differ with me haha
  • P
    Petr
    United-Mannkind received their CRL (due to open inspection issue at a third-party analytical testing facility) same day as Avadel received the delay news.

    Interestingly, FDA already discusses the labeling for United-Mannkind drug.

    MNKD -17.88% at the moment, shedding $227M from their market cap.
    UTHR -1.16% at the moment, shedding $97M from their market cap.
    AVDL -14.01% at the moment, shedding $82M from their market cap.

    I see it as positive sign for Avadel.

    Just my personal opinion.
  • A
    Allen
    I’m adding to my position. No CRL. ‘Not likely in October’ means to me early November. They’ll announce date very soon. I have no worries.
  • J
    John
    As crazy as it sounds, I think AVDL could trade UP on Monday as the market can be very efficient with biotech stocks in looking past the headline to the essence of what a development means… and in many ways, despite the delay, the odds of an Approval for FT218 appear higher today than they did before Friday as we now know there have been no deficiencies identified and no requests for a P4 certification. Market can be pretty smart and the smart thing to do here is to be more confident in ultimate success than you might have been a week ago. Bad news if you were playing with Oct options. Nov options may or may not be okay (probably will be ok IMO). But anybody playing with stock or options that expire after Nov should feel even better (as long as they don’t have anxiety issues).
  • S
    Satoshi
    Not sure what’s taking so long for the market to react. I think I may just be early. I’m buying here.
  • C
    Chaplin
    Here is the abstract book from this weeks American Neirological Association 2021. There are 3 abstracts for FT218 posters 279, 285 and 286. These are sub-analyses of the REST-ON trial and all look positive to me. Perhaps someone with a more scientific leaning could read them too. Remember that they can’t promote the drug yet and so have to use the phrase ‘the result suggest that FT218 might treat …’.
    Just load the document and search for FT218:

    https://2021.myana.org/sites/default/files/images/2021/2021_publication_final_-_oct_8_embargo_0.pdf
  • A
    Andras
    And here is the first class action lawsuit announced by one of the law firms. Against AVDL, and because the FDA failed to meet its deadline. Why don't they sue the FDA?
  • G
    Gary
    Barrons has an article on the FDA and some big decisions coming before year end. Avadel is listed but not discussed. The list shows two other decisions past their deadlines (for Pfizer and Abbvie). To me, it looks like the FDA is somewhat overwhelmed given Covid and everything else in the queue. I am a long time holder with a significant position who will be holding through any new decision date as I believe FT218 will be approved.
  • C
    Chaplin
    Well this was a nice bit of news to wake up to... Avadel shares new data for narcolepsy candidate from pivotal trial https://seekingalpha.com/news/3754969-avadel-shares-new-data-for-narcolepsy-candidate-from-pivotal-trial
  • P
    Petr
    My 2 cents about the delay:

    Oblio stated "Minor labeling issue involved here." Where is THAT stated? I mean, this can be CMO issue - look at VRCA. In their CRL PR they stated, that they were not notified by the FDA of any deficiencies at CMO prior to CRL. This can be labeling issue. This can be covid backlog. This can be almost anything.

    My point is - we don't know. FDA apparently has its ways and as much as it may seem as suspicious, it concerns other drugs under review as well. Look at SLGL: NDA for EPSOLAY still pending due to COVID-19-related restrictions... since April 26th target date.

    So until we know what the issue is, we cannot speculate about scope of the delay. If it is something that needs broad amendment, this may result in CRL and year of delay. If it is CMO issue, this may resolve quickly depending on how good the manufacturing facility is. Example: CRMD - CRL for CMO issues 1st of March, in September corporate update "the timeline to address deficiencies uncertain at this time".

    I personally believe that this will be not some big issue and new target date will be 3 months from now and the decision may come anytime between end of November and mid December. If something like this happens, I think the downside will be pretty limited. If any hint of big delay comes out, this really may drop 40-50% or more.

    All just my opinions.
  • M
    Mathew Fuji
    I think we need to atleast spend some time discussing the impact of the new IP on other potential once nightly like KWPh. This is something Trin had accurately predicted based on analysis of all published PK profiles (valproate, Xyrem and FT). I had brought this to Divis and obviously he wouldn’t say anything for the rightful reasons. But now the news is out and Jazz also knows that (potential) aspect of the FT218 label.
    Bruce we have still not out a name to this baby so don’t waste more time. Walking in the corridors of the FDA with whoever Jack spotted in his dreams ain’t in reality going to work.
    They should have at the worst case around $180M in cash. FDA hasn’t said anything other than we are still completing the review and may not be done in October but don’t need anything more from you at this point.

    If I was a fund that shorted to keep this below $10 on the expiry day I am already heavy in short position. I may still use some $$ to short in an attempt to cover low on the backs of hapless retails. Just my 2 cents
    6 analysts including BOA is out with their position on this. We have also seen responses others have got so do your own DD