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rafunrafun,Why would you conclude "the time for an

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MedResCollab   Thursday, 07/11/19 09:57:03 AM
Re: rafunrafun post# 201001
Post # of 339267 

Why would you conclude "the time for an AdCom has expired" when the FDA specifically states in guidance the following:

-mid-cycle review for Priority Review apps: ~3 months into review timeline
-mid-cycle communication: within 2-weeks of mid-cycle review

and further states that one of the purposes of the mid-cycle communication is to tell the applicant of finalized plans to hold an AC meeting or not, and if plans to hold one, communicate the date (and also tell them when that will go live on FDA.gov).

As HDGabor pointed out, the CEO stated that the mid-cycle review occurred--or he was informed it was planned to occur--on June 28th. Two weeks from 6/28 is 7/12, or tomorrow. And knowing how FDA usually handles timelines, that will probably mean the mid-cycle communication will occur exactly on 7/12, or on 7/14, though it could be today, and could even be somewhat later than 7/14. These are "goals," not guarantees.

The mid-cycle comm is a "communication," meaning they actually talk, usually on the phone (CC). The applicant can and should ask questions. Although it's highly likely that FDA will tell them "no current plans to hold an AC meeting" if there are no current plans to, the applicant (Amarin) can and very probably will outright ask them if not given an answer, and will (as promised) report the answer by PR. And, of course, if there will be one, FDA will communicate that directly (and the date).

So, in actuality, the most likely time you will hear of the content of the mid-cycle comm, including on whether there will be an AdComm and the date, is after hours tomorrow, or Monday morning, with somewhat less probability after hours today, and less probability each day after the 14th. The "window" is not closed, it is not "expiring," and if anything we've finally come into the most likely time an AC meeting and the date will be reported regarding AMRN.

If/when the AC meeting comes, keep an eye out for the stated "Agenda."



The committee will discuss supplemental new drug application (sNDA) 205832 for nintedanib capsules (drug name OFEV), sponsored by Boehringer Ingelheim, for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). The focus of the discussion will be whether the application provides substantial evidence of efficacy for the proposed indication.



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