Replies to post #197785 on Amarin Corp Plc (AMRN)

[HDGabor]

Seriously …

(i) FDA intends to convene AC meetings
(ii) July 31 means they miss the 2 months by 4 days … well above 6 weeks ...

[MedResCollab]

Sts66,

You do raise a pertinent point that FDA can decide to convene an AdComm meeting at an unpredictable moment during review. It’s best to plan for one early in the review cycle, and that is by far most common, but they are not prevented from deciding later on to hold one. Sometime in late July for this review you could suddenly hear of one being decided. Although rare, it is certainly possible.

We think it is likely we’ll hear of the decision to hold one over the next two weeks, and for the following reason (which was also the reason behind the ANCHOR AC):

The application raises significant issues on the safety and/or effectiveness of the drug or biologic... -FDA Guidance