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Avadel Pharmaceuticals plc (AVDL)

NasdaqGM - NasdaqGM Real Time Price. Currency in USD
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9.99+0.65 (+6.96%)
At close: 4:00PM EDT
8.56 -1.43 (-14.31%)
After hours: 07:59PM EDT
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  • O
    Oblio
    I propose a new rule. For every day the FDA does not make a decision when they typically get 10 months unless it is an expedited approval, the sponsor gets some of the application fee refunded. Avadel paid to have 218 reviewed in a timely manner. Considering the nature of the drug/application, 10 months was way more than enough time to do their job.
  • E
    Erin R.
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  • 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.
    Bullish
  • T
    Trin
    I think the reason why this is delayed is due to the fact that fda has to determine an orphan drug exclusivities by the pdufa, which takes time and wasnt taken into account when they scheduled the whole review on february 2021 when the nda was accepted.

    I dont think this will be delayed for greater than the length of time it usually requires to determine whether one should be granted ode.
  • F
    Fosco
    Well, well
    While news is disappointing as we were all expecting a decision today, situation is far from being the end of the world. Some positive titbits can even be deduced from the communication. Look what happened to AXSM when they announced FDA delayed decision, it skyrocketed because no bad news was incorporated in the press release.
    Just a little more wait.
    Longs will stay longs, traders will trade, and I will buy more on the cheap if some weak hands sell, and life will go on.
    GL all
    Fosco
  • O
    Oblio
    What we have here is a $35 stock still trapped in a $10 body. The metamorphosis has just begun.

    Two years from now patients will be driving around in their Teslas with great satisfaction. The Jazz warehouse will be filled with low salt buggy whips nearing expiration dates. Divis should send Brucie a nice present.....an expired drug incinerator.
  • P
    Petr
    I looked at target dates for Friday for other companies this year and two of them I found issued their PR (approvals) Friday after market closed, but as far as I see not after 4PM, but later around 7-8 to 10 PM. Not sure why - guess it is up to each company to choose the timing and some maybe didn't want to create after-market frenzy?

    So probably the decision whatever it is will be communicated after the market close, the possibility I see to get the PR in the pre-market today is if the FDA made the decision yesterday.

    All just my opinion.
    Bullish
  • O
    Oblio
    Avadel has the "secret recipe" from France that Brucie could not figure out how to make despite his $1.8 BILLION annual windfall from selling his buggy whips.

    Just wait until Avadel announces their intention to formulate a ONCE NIGHTLY low sodium product.

    Avadel is gonna completely take over the SO market!

    Twice nightly = buggy whip
    Once nightly = Tesla
  • P
    Petr
    Quick question to you guys: are you holding to all your shares you have or are you selling before EOD portion/everything?

    I am considering selling 25% of my position, just in case we get CRL, because I have no access to options and my position is in full risk at the moment and there is no other way for me to protect the profits. Still reluctant to do so though.

    Just my personal opinion.
    Bullish
  • a
    alex
    Guys. If you believe in the company and have $10 calls with cash available. Call your trader and exercise the calls. People will be crying later for those shares.
  • J
    Joe
    Nobody said the delay will be 3 months. The article said the FDA will announce when as soon as possible. So that could mean the new PDUFA date will be set for November
  • O
    Ouch
    What this appears to be is that the FDA still a bit backlogged, but there is good news here:...no additional data requested & no CRL....AND, according to Fuji, they are at the point of appropriate labeling discussion(ALWAYS the very last stage)...I am guessing one or two months for Brucie to milk his "dead twice-a-night sodium oxybate-man walking" drug....
  • J
    Jeff
    Petr your another nervous Nellie! Frigging relax as this will be approved sooner rather than later if you don’t believe that sell and move on! All of these retail investors on here who think they have any idea of what is going on? Move on and good riddance! I and many others will make a lot of money! I never post but I know this will work as I have deep faith and believe!
  • t
    tony
    This stock could truly explode on approval. Price runs hard and fast on even minimal volume as is the case this morning in premarket. With float of about 45M and 56% of that float owned by Tutes, that leaves about 20M for public consumption, and over 3M of the remaining float being shorted, this could get very interesting in a hurry today or Monday.
    Bullish
  • K
    Kirk
    From the press release:
    "...a new target action date will be provided as soon as possible".

    Why would they say that if this delay was anything other than FDA workload overload?
  • O
    Ouch
    I am soon either going to be celebrating and ordering Japanese Wagyu beef, porter steaks & ribeye's, fillets of tenderloin, & lobsters paired with the finest Napa wine ALL week...or.. will be swigging a lot of Pepto Bismal....What's it gonna be, Sweet Avadel?!?!?
  • P
    Pickens
    DUBLIN, Ireland, Oct. 15, 2021 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administration (FDA) notified the company that the review of the New Drug Application (NDA) for FT218 is still ongoing, and action will likely not be taken in October. The FDA informed the company that there are no information requests at this time and a new target action date will be provided as soon as possible.
  • A
    Andras
    I'm not happy because of the delay, though I will hold all my shares, or even add some if price goes below 6. I hope Divis will organize a conf call explaining the situation, and what to expect based on what is known.
    Few questions to the experts on this board:
    - Will AVDL be compensated in any way by FDA?
    - Does the delay affect whatever is scheduled to happen on court in Nov? Wasn't it tied to FDA approval?
    - Can we assume that market launch will be delayed by 1 Q?
  • t
    tony
    Don't forget if they want to announce the approval during market hours, expect a halt. A halt is required for such a material event. Remember a halt will not mean approval or denial either way. We will only know when shares resume trading. So if you see a halt in trading do not panic.
    Bullish
  • T
    Tom
    Always remember that the FDA has the right to issue a three month delay. That is always a good buying opportunity because retail investors are not that smart and immediately assume it's bad news (most of the time it isn't).
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