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rafunrafun,There are a few key points in time

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MedResCollab   Wednesday, 07/10/19 07:46:05 AM
Re: A deleted message
Post # of 339267 
rafunrafun,

There are a few key points in time in which the FDA will inform an applicant whether it plans to hold an AC 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 CEO really should have said nothing about it.

The market, and numerous posters/investors do not 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. No, it is probably more like >80% chance there is one now.

Regards,
-MRC

...
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