The exact wording in the 8-K: "Amarin is working with the FDA to schedule a Type A meeting to discuss with the FDA, as permitted by applicable FDA guidance."
"T(t)o schedule" implies that the request of the meeting has been filed -- just waiting for a schedule. So, the meeting would take place around Nov 29.
"One-sided" story is easy to tell hard to accomplish. And reading the transcript carefully, I don't think the company weighed too much on reinstalling SPA.
I don't think that FDA will reinstall SPA (almost zero chance in my view -- SPA leads to an unconditional approval on ANCHOR), but willing on compromising at a lower issue.
Are you sure of "company officially requested meeting on 11/7"? In my memory, 11/7 was the CC date, and the request of Type A Meeting was filed on 10/29.
Everyone on this board with high triglyceride should ask Doctor for Vascepa. If Doc doesn't know it then educating the Doc.
It will be an appeal to higher leader of FDA. Supposing the case was handled by Divisional level, there are several levels ahead: office level, center level and top administration level, and it will be one step at a time.
Reading the transcript of last CC carefully, found that the company is wildly open to a range of options:
Inserting ANCHOR data to MARIN label without any CVD language; (easiest one, if FDA nods on it)
ANCHOR label without CVD language; (small probability)
ANCHOR label without CVD language and with contingent of REDUCE-IT; (mid probability)
Removing the rescission on SPA. (very hard)
The distinguish of an "FDA approved prescription drug" from an "FDA regulated medical food" is huge. Patients have confidence on the former, but "a try" to the later. Particularly, Doctors, primarily, are prescribing former with guidance from, say, American Heart Association.
I, perhaps, know that you just provide an alternative way for Vascepa. However, that may be not a passing-thro.
To AMRN MGMT:
Dealing with FDA, don't be stiff. Be flexible and compromiseable. You may not get all you want, but getting something you want is good enough.
I've been in Bio/Pharma long enough, followed many AdComs, Appeals, Approvals and Rejections. What I have never seen is the reaction to this AdCom. E.g., a CP with more than 1,000 signatures. Someone would say "FDA doesn't care." May be or may be not. Some companies lost with Appeal, and some companies got what they appealed for. We have to wait and see. In nowadays, anything could happen. E.g., FDA broke SPA ;)
"Pending upon REDUCE-IT" is not a rejection. Thus, there won't be a NO on Dec 20, in my humble opinion, given the safety and efficacy of ANCHOR. FDA is "creative" -- they always have set something "historically". I couldn't wait for Dec 20 coming to see what is it, in the "hat" or "pants".
Any media coverage, liberal or conservative, would be much helpful to bring the case under sunshine.
Prior to vote, Colman conclude: "If there are no further comments, I will endeavor to summarize what this group has said and after that, I will ask you to amend and correct my summary. I think with the view expressed is that the consensus there has been concern expressed about the placebo group against this was measured regarding the potential for overstatement of the triglyceride lowering effects that is a concern but not a conclusion that is that an appropriate placebo group."
In fact, the doubt about "placebo inertness" was "Made in FDA" by omitted most relevant data in their Briefing. I have a research note: " A Research Note on Placebo Inertness in Vascepa's ANCHOR Study" to point out FDA's wrong doings on the "Placebo Inertness" issue.
Vote Under Influence, it is INVALID.
Accordance with this Law, I have emailed EMDAC to order a copy of the transcript of Oct 16 AdCom Meeting. Whenever the transcript be received, I will post some details.
Contingent fee firm, the two major class action firms are Bernstein Litowitz and Robbins Geller.
Other firms that might take this on some non-hourly basis are Boies Schiller ( Jon Sherman) and Quinn Emanuel ( Jen Barrett)
November 16th in Dallas, new guidance will be published. Mark your calendar! That is important much more than those studies on fen fibrates and niacines.
Law: Federal Advisory Committee Act
The Federal Advisory Committee Act became law in 1972 and is the legal foundation defining how federal advisory committees operate. The law has special emphasis on open meetings, chartering, public involvement, and reporting. This version is from the House web site, complete with all Amendments and annotations.
Sec. 11. Availability of transcripts; ''agency proceeding''
(a) Except where prohibited by contractual agreements entered into prior to the effective date of this Act, agencies and advisory committees shall make available to any person, at actual cost of duplication, copies of transcripts of agency proceedings or advisory committee meetings.
(b) As used in this section ''agency proceeding'' means any proceeding as defined in section 551(12) of title 5, United States Code.