HDGabor,
You may be helped by reviewing the 21st Century Review Process Desk Reference Guide, which review staff themselves use for reference from time to time. Though we caution against interpreting anything in it without the assistance of a regulatory specialist. There will always be a gap in knowledge for those without real-world experience in a matter, whose knowledge can only be incomplete by doing Google searches and attempting to self-teach from the outside looking in. This is why consultants are key to have. We recommend you find a consultant that has served in regulatory affairs, perhaps as a representative liaison (as our member has). They can help quickly answer such question that are difficult to "prove" by quoting online guidance documents.
We reassert, the Filing Communication (day-74 letter) is always sent to the applicant regardless of whether or not the application is given Priority Review (P) or Standard Review (S). The "Priority Review Determination" letter due on or by day 60 referenced by you in guidance documents for industry does not preclude the "day-74 letter," also known as the "Filing Communication." Your suggestion that the possibility of an AdComm must be communicated to the applicant by day 60 for P applications, because there is no day-74 letter for P applications, is misinformed.
The Filing Communication, which is always sent on day 74 of the review (goal, it may be a bit late) is not only used to communicate to the applicant the review designation (for S apps) and "Filing Issues Identified" or "No Filing Issues Identified" letter (which, if ready is sent to the sponsor of P applications along with the "Priority Review Designation" letter- if not ready it is sent as part of the "Filing Communication" aka "day-74 letter"), but for other purposes. These include the following:
-the planned timeline for review activities, including, at a minimum the target dates for transmitting initial labeling and PMR/PMC comments;
-the planned date for the internal mid-cycle review meeting;
-preliminary plans on whether to hold an Advisory Committee (AC) meeting to discuss the application; if no plans, they will advise they are not currently planning to hold an AC meeting.
At the internal mid-cycle meeting (~ 30 days into review for P apps), management reviews the progress made thus far by the review team, including confirmation of decision to hold AC meeting (of which the sponsor was advised in the day-74 letter) and timeline. This is then conveyed to the applicant no more than two weeks following the meeting.
And so, yes, an AC meeting is still very much on the table and could be reported late June/early July. But also, if during review, say in mid July an issue arises that informs FDA it is pertinent to hold an AC meeting then they will at that time plan one and once plans are finalized will inform the applicant. As an investor if you are concerned of an AC you really cannot let down your guard, as surprise announcement could also occur (though admittedly is rare). With the Vascepa efficacy supplement that could potentially occur into August.
Our view is the most likely outcome is an AC meeting, and announced late June/early July.
Regards,
-MRC Team
