”Biobillionaire,” (by far our favorite handle)
Your example is faulty/relates to Standard Review; an AdComm (AC) meeting may take place up to six weeks prior to PDUFA date for Priority Review applications.
Notice of preliminary plan to hold AC meeting, or the notice that FDA is not planning one at this time, is sent in the day-74 letter. Evidently, by the GS conf (June 12th) Amarin had not yet received the day-74 letter. The notice of Priority Review Designation came late to Amarin, and it appears the day-74 letter did too (they will almost certainly have received it by now). This notice of intent or non is not information that needs to be publicly disclosed, and is confidential between the FDA and the sponsor (much as ongoing buyout negotiations would be). At the internal mid-cycle meeting (~ 3 months from receipt of app if granted Priority Review) the FDA will reintroduce the matter of an AC and if it’s a go will plan a date. Within two weeks after that, the sponsor is informed. And soon thereafter you will see the date publicly appear. It is this last point that makes disclosure necessary, and the sponsor will then have to issue a press release to that fact if the company is publicly traded and if the info is deemed material (an immaterial app by PFE given an AC date is not required reporting).
A couple of interesting things here. An AC is even more likely now. The reason being that it is very likely they received the day-74 letter telling yea or nay to an AC at this point, and if it was nay, we feel the sponsor would have reported the FDA told them no current plans to hold an AC, to, well, relieve those investors that are tense about it and hope there isn’t one. So the odds of an AC are even higher now, in our view.
The most likely window in which the FDA will inform the applicant (Amarin) of an AC date is between June 26 - July 10, based on precedent. Sooner is less likely and so is later (but later is more likely than sooner). The fact that other trials have AC dates that extend into July (or later) is of no consequence, and are pertinent to those trials only.
Regards,
-MRC Team
