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The nearest potential negative catalysts:

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MedResCollab   Wednesday, 07/10/19 01:49:14 PM
Re: None
Post # of 339961 
The nearest potential negative catalysts:

There are a few key points in time in which the FDA will inform an applicant whether it plans to hold an AdComm meeting or not. The most common being the day-74 letter. And so we expected it to reveal to Amarin FDA's preliminary plans to hold one or not. When the CEO emphasized as late as June 25th that they have been told absolutely nothing either way about it, then it became clear the FDA was waiting until the mid-cycle internal review to discuss and finalize plans for an AC meeting (meaning one is likely), and planned to convey that to the sponsor in their mid-cycle communication (within two weeks after review). Otherwise, in their day-74 letter they would have very succinctly stated to Amarin, "FDA does not currently plan to convene an Advisory Committee meeting."

The market, and numerous posters/investors do not seem to realize the events up until now actually make the possibility of an AC meeting much more likely than not. We've read 95%, 90%, 99% etc chance of no AdComm. In our view, it is probably more like >80% chance there will be one now.

So the AC meeting announcement is one catalyst. A negative catalyst if it occurs because by far and away the most common reason for FDA to request one is:

There are significant issues regarding safety and/or effectiveness of the drug or biologic. --FDA

Another potential catalyst that would be highly negative, but has a much smaller chance of occurring, is a clinical hold on EVAPORATE. And still another catalyst is the potential for an out of the blue extension of the PDUFA date. Though this usually occurs much closer to the planned PDUFA date, an extension can be decided earlier:

...Solicited amendments [requested by FDA; i.e. blood pressure data from REDUCE-IT?] are usually reviewed during the current cycle provided they are received early enough. The RPM processes the amendment and distributes it to the review team.

Extending the Review Clock: A major amendment (e.g., a significant amount of new information, new analyses, new study or trial report) can extend the review clock (PDUFA goal date) three months. The review team decides whether to extend the review clock and review the information or defer review to a subsequent review cycle. This decision should be based, in part, on whether the amendment has the potential of bringing the application into condition for approval. If there are deficiencies that cannot be addressed by the amendment, the division should generally defer review of the amendment until a subsequent review cycle without extending the review clock. If the review clock is extended, the RPM sends an Extension Letter to the applicant to notify them of the new goal date. If the planned date for discussion of labeling and PMRs/PMCs is changed, the RPM will notify the applicant. (See MAPP 6010.8)

For PDUFA V [and VI] “Program” applications [including current Vascepa sNDA], the new planned review timeline will include a new planned date for the internal mid-cycle review meeting, if appropriate, depending on when during the course of review the major amendment(s) is accepted for review. All other milestones are adjusted to the new goal date

FDA could tell Amarin via an Extension Letter that they are pushing back the PDUFA date, and also mid-cycle review. Although this usually occurs later on in the review cycle, after the mid-cycle review had already taken place, with the applicant notified much closer to PDUFA date. It still exists as a significant overhang to an investment in AMRN (as does the AC meeting announcement, and, though less likely, a clinical hold on EVAPORATE) at any time before Sept 28th.

So, either:

-mid-cycle internal review occurred, and the mid-cycle communication with Amarin will occur soon, with FDA clarifying whether or not AdComm meeting will be convened, and if it will, when. Amarin will then notify the market yea or nay on AC meeting promptly thereafter.


-FDA is sending instead an Extension Letter to Amarin, notifying them of a push back to the PDUFA date and mid-cycle review (this can also happen later). They may also inform Amarin of plans to hold an AC meeting therewith, or wait until the pushed back mid-cycle communication to inform them.

These are the current regulatory risk/overhangs facing Amarin.


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