Replies to post #201001 on Amarin Corp Plc (AMRN)

[jessellivermore]

raf...

I agree and have predicted no AdCom...IMO..FDA does not want the previous AdCom brought up...as FDA played fast and loose with the rules...Not because of anything Amarin did...but because FDA made a huge mistake in offering the ANCHOR SPA without requiring Amarin to do an outcomes trial.

They had to close ranks on Amarin and withold the label expansion..FDA now has the outcomes trial results...and R-I results are such that they answer all questions...Mary Park's famous question in 2013 was...(Paraphrasing).."Considering the ANCHOR Trial...how confident do you feel that Vascepa will lower CVD event risk?"....The answer had to be...I don't feel very confident"...because all ANCHOR showed was Vascepa would lower trigs....and not raise LDL-C...But there was no proof V would reduce CVD events because ANCHOR only measured trigs and other blood levels...but it did not measure V's effect on reducing CVD events..

REDUCE-IT was the outcomes trial that sanctified Vascepa...All of us including FDA (well maybe there is a guy out there that doesn't understand the R-I trial results)...But believe me the FDA does...

Thank you Amarin, Dr. Bhatt, Dr. Miller and all the patients in RI..and the doctors that monitored them...They have helped us financially and more importantly saved a lot of lives...

":>) JL

[marzan]

Agree Raf, I think FDA is going to surprise us approving the sNDA straight way earlier. BB predicts could happen sooner than 7/24, the day ICER draft report is scheduled to be out. Very possible! JL explained real well on why there will be no Adcom. Crystal clear as all the evidence FDA was asking for is already made available. FFS is predicting the reversal on the 3rd Day as the Street might be loading more cheap shares on top of the 60M+ they scooped in the last few days. Best Wishes!

[MedResCollab]

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.:

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