Home > Boards > US Listed > Biotechs > Amarin Corp. PLC ADS (AMRN)

rafunrafun,Why would you conclude "the time for an

Public Reply | Private Reply | Keep | Last ReadPost New MsgNext 10 | Previous | Next
MedResCollab Member Profile
 
Followed By 2
Posts 211
Boards Moderated 0
Alias Born 01/18/19
160x600 placeholder
Clinical Data and Other Research Results Regarding VASCEPA® (Icosapent Ethyl) and Its Unique Active Ingredient to Be Present... GlobeNewswire Inc. - 5/4/2021 7:00:00 AM
Amarin reports decline in Q1 revenue ahead of European launch of VAZKEPA Seeking Alpha - 4/29/2021 7:31:32 AM
Quarterly Report (10-q) Edgar (US Regulatory) - 4/29/2021 6:36:55 AM
Amarin EPS beats by $0.07, misses on revenue Seeking Alpha - 4/29/2021 6:16:54 AM
Amarin Reports First Quarter 2021 Financial Results and Provides Business Update GlobeNewswire Inc. - 4/29/2021 6:10:00 AM
Amarin Announces Planned Retirement of Joseph T. Kennedy, EVP, General Counsel GlobeNewswire Inc. - 4/29/2021 6:00:00 AM
Amarin Q1 2021 Earnings Preview Seeking Alpha - 4/28/2021 1:06:54 PM
UK approves Amarin's Vazkepa for cardiovascular risk reduction Seeking Alpha - 4/22/2021 11:22:31 AM
Amarin Receives Great Britain Marketing Authorization for VAZKEPA from the Medicines and Healthcare Products Regulatory Agenc... GlobeNewswire Inc. - 4/22/2021 10:53:02 AM
Amarin to Report First Quarter Results and Host Conference Call on April 29, 2021 GlobeNewswire Inc. - 4/20/2021 6:05:00 AM
VASCEPA® (Icosapent Ethyl) Reported to Impact Vulnerable Coronary Plaque Features in New Analyses of EVAPORATE Study Present... GlobeNewswire Inc. - 4/17/2021 9:50:00 AM
Amarin: Could the New CEO Help Vazkepa’s European Push? TipRanks - 4/13/2021 3:05:37 PM
Amarin falls as new CEO may mean M&A less likely in the near term Seeking Alpha - 4/13/2021 8:08:18 AM
Amarin CEO John Thero to retire Seeking Alpha - 4/12/2021 4:36:21 PM
Amarin Announces CEO Succession Plan GlobeNewswire Inc. - 4/12/2021 4:30:00 PM
Amarin Commences Commercial Initiatives for VAZKEPA in European Union Following Recent Regulatory Approval for Cardiovascular... GlobeNewswire Inc. - 4/6/2021 6:05:00 AM
Amarin wins EU approval for icosapent ethyl to treat cardiovascular patients Seeking Alpha - 3/30/2021 7:42:41 AM
Amarin Receives European Commission (EC) Approval for VAZKEPA to Reduce Cardiovascular Risk GlobeNewswire Inc. - 3/30/2021 6:24:23 AM
Amarin announces clinical recommendations for Vascepa in Canada and Egypt Seeking Alpha - 3/29/2021 10:33:15 AM
Fifteen Medical Societies Now Recommend Icosapent Ethyl to Reduce Cardiovascular Risk, Further Supporting that VASCEPA® is R... GlobeNewswire Inc. - 3/29/2021 7:00:00 AM
Nextech AR (OTCQB: NEXCF) Doubling Sales - Emerging Growth Report InvestorsHub NewsWire - 3/24/2021 6:45:37 AM
HLS Therapeutics highlights promising VASCEPA data analysis Seeking Alpha - 3/17/2021 11:55:39 AM
VASCEPA® (Icosapent Ethyl) Found in Prespecified and Post Hoc Analyses to Significantly Reduce Stroke in At-Risk Patients in... GlobeNewswire Inc. - 3/17/2021 11:30:00 AM
Amarin Q4 results led by strong Vascepa sales Seeking Alpha - 2/25/2021 9:48:43 AM
Current Report Filing (8-k) Edgar (US Regulatory) - 2/25/2021 6:07:01 AM
MedResCollab   Thursday, 07/11/19 09:57:03 AM
Re: rafunrafun post# 201001
Post # of 339267 
rafunrafun,

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."

Ex.:

Quote:
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.



https://www.fda.gov/advisory-committees/july-25-2019-meeting-arthritis-advisory-committee-meeting-announcement-07252019-07252019

Regards,
-MRC


...
Public Reply | Private Reply | Keep | Last ReadPost New MsgNext 10 | Previous | Next
Follow Board Follow Board Keyboard Shortcuts Report TOS Violation
X
Current Price
Change
Volume
Detailed Quote - Discussion Board
Intraday Chart
+/- to Watchlist
Consent Preferences