Thanks, good to see your still around. This is a fight worth staying in...the science is strong and FDA has crossed the line.
Monday isn't the normal FDA due date...ignored due to "complex regulatory issues requiring" time to circle jerk. They post the regulatory letter or they #$%$ off Federal Judge that set the tightest most restrictive schedule possible for FDA. Guessing he's heard the "complex regulartory issue" BS numerous times.
Nothing yet filed on ECF
No new Regulation announced by FDA.
Past Pharma that where fined Billions, broke the law that's the line. Amarin has been through all administrative means to get truthful info on label, the injustice is clear. The excuse the FDA will lose the ability to regulate is laughable, they have proven time after time they have no ability to regulate in a fair or safe manner. The examples don't even start at Vioxx, but it's the one most are familiar with.
Granting Anchor narrows scope of suit, the scientific evidence that EPA reduces cardiac events is vast and has been ignored by FDA.
The FDA promised a Federal Judge, to issue Amarin a "regulatory" letter by Friday to Amarin. This "regulatory" letter would narrow the argument and scope, allegedly, of Amarin First Amendment claims.
Last night the Federal Registry contain no new "policy" in regards to "off label marketing". So the "regulatory" letter must be a regulatory label change.
The FDA used this carrot, to lure a Federal Judge into changing the already preset schedule...
You do not anger a Federal Judge by lying to them. He saw through the FDA BS and ORDERED them to post this "regulatory" letter by Monday to PACER.
FDA can either negotiate a final label with Amarin or lie to Federal Judge and lose this case out of the starting block.
Just my opinion...but I was correct with NCE...took 3 years to get that Justice.
Correct. 2011 Vascepa is NCE, Months later after tox studies FDA is unsure will decide at approval, exclusivity held 18 Months, Anchor SPA rescinded, FDA assigned 3 NME.
That's just the public stuff...
Wrong....the move yesterday was a filing to postpone Generic Lawsuit, should see an order from the Judge soon. All parties seem to agree, when NCE is granted this case is over.
remember this regulatory letter will be posted to PACER on Monday per Judge order. I believe this was the move we saw at 1:30 yesterday.
I feel the sites have two purposes, IHUB contains sophisticated longs with knowledge of the science...but most bury their head deep in the sand when it comes to the legal, regulatory and political aspects that has made AMRN a very poor investment choice. The investors that where right about investing in Amarin in 2012, betting that it would tank, where correct. Adam & Matt Herper knew the FDA had plans to take Amarin down, this is easily seen in both their writing styles leading into all catalysts. Forbes and The Street has been used as a mouth piece to weaponize regulation.
This has steam rolled into a huge antitrust issue, FTC is attempting to quell the situation. I intend to show them they will make it worse if they continue. FTC should step in and prosecute this for what it is.
The steam is building in both the House and Senate, it cannot be contained.
Yahoo contains some of the seedy elements that should be warned, this is not the "ordinary" bio tech take down and we aren't a bunch of loud mouth "donkey's" sitting in our mom's basement. I don't want to prosecute the stupid, just the players pulling the strings.
Sentiment: Strong Buy
Complaint: Misuse and abuse of Regulatory Scheme, delaying exclusivity for an FDA approved drug, Incorrectly assigning exclusivity, and delay in assigning exclusivity after a Federal Judge issued Order
FDA, Office of CDER & Amarin Pharma Inc.
Amarin Pharma filed a NDA with FDA; it was approved 7-26-2014, but not assigned exclusivity with approval. The regulatory scheme of the FDA, guided by an official MAPP, is to assign exclusivity at the date of approval. In October of 2012 I contacted Virginia Behr, CDER Ombudsman, we had numerous email communications and two phone conversations involving the exclusivity process scheme FDA was currently applying to Amarin. In February 2013 FDA (CDER) accepted a Citizen Petition from former FDA Attorney John Fuson. I requested a conflict of interest and also statutory review of the eligibility of a FDA former employee to file such a Petition within the time frame of employment. I also requested a statutory review inquiring if this particular Citizen Petition was delaying the completion of Amarin’s NDA, assignment of exclusivity.
In an email communication, Ms. Behr confirmed there’s been no violation of law or regulation; but labeled the communication as “unofficial”. Communications regarding Vascepa exclusivity continued for 18 Months until the FDA assigned Vascepa 3 years of NME. At this juncture the FDA accepted 8 generic drug applications that are currently trying to discredit Amarin’s Patents. This lawsuit has progressed into discovery phase and the damages done are inconceivable.
After the FDA assigned NME 2-21-2014, Amarin Pharma Inc. due to the fiduciary responsibility of being a publicly traded company, filed for a summary Judgment.
This Judgment was granted 5-28-2015, and found the FDA grossly not complying to the law.
FDA has 60 days to appeal a decision they delayed for 18 months, against their own rules.
They have killed more American's than all War's combined. The only solution is to eliminate them...your welcome to join in on the process.
1) Document facts
2) Report those facts to Congress
3) Hold Congress to their sworn Constitutional Oath
NIH can take over the simplistic duties of FDA.
Technically you would be correct, with the center of the Earth bulging out with centrifugal force, more than the poles. I'm sure Swalchie's got a smarter friend with an opinion though.
Interesting timing. Amarin needs both a US & Europe partner. Kowa dropped Fibrates when signing deal with Amarin. Those are facts. Anyone know how much $$$ LIPTRUZET pulled in?
Guidance out by Friday, means nothing to Amarin or stakeholders. The FDA is sending Amarin a letter, "to issue a regulatory letter to plaintiffs providing the agency's view as to the proposed communications about Vascepa discussed in the complaint."
Judge has ordered this to be part of record due 6-8-2015.
Somehow the FDA will have to unwind the damages to Amarin and stakeholders by next Monday for Amarin to drop this suit.
IMO, this is an impossible task.
Best FDA could due, immediately update OB with NCE for Anchor + Only (considered similar to Orphan carve outs) starting 6-3-2015 through 6-3-2020.
Reinstate Anchor SPA, grant conditional use in REDUCE-IT (may prevent CV events) after reviewing current REDUCEIT safety data.
All by Monday...Not going to happen.
Amarin filed suit May 7th, FDA didn't acknowledge case until May 27th...just after an extremely tight schedule was set by the Judge.
"ORDER: On May 22, 2015, plaintiffs filed a motion for a preliminary injunction, Dkt. 5, and a supporting memorandum of law, Dkt. 13. The Court hereby sets the following briefing schedule: Defendants' opposition to plaintiffs' motion shall be submitted no later than June 12, 2015; plaintiffs' reply shall be submitted no later than June 19, 2015. Oral argument is scheduled for Tuesday, July 7, 2015, at 9 a.m. Set Deadlines/Hearing as to  MOTION for Preliminary Injunction: (Responses due by 6/12/2015, Replies due by 6/19/2015.) (Oral Argument set for 7/7/2015 at 09:00 AM before Judge Paul A. Engelmayer.) (Signed by Judge Paul A. Engelmayer on 5/26/2015) (kko)"
Yesterday, FDA likely contacted Amarin...similar to the communication with Big Tobacco. Notifying Amarin FDA was coming out with new policy, FDA hoped Amarin would drop suit as Tobacco did. Two vastly different financial situations and circumstances. Amarin likely said, F&^%$ off. This trigger FDA to submit the request to alter the above schedule.
ORDER granting in part and denying in part  Letter Motion for Extension of Time to File Response/Reply re:  MOTION for Preliminary Injunction. Oral argument, currently scheduled for July 7, 2015, at 9 a.m., shall proceed as scheduled. See Dkt. 14. However, to give the Government time to thoughtfully address in its brief certain regulatory guidance which it states will be issued on June 5, 2015, the Court will modify the briefing schedule as follows: The Government's opposition to plaintiffs' motion for a preliminary injunction is now due June 18, 2015. Plaintiffs' reply is now due June 25, 2015. The Court further directs the Government to file on ECF the FDA's regulatory letter by June 8, 2015. The Clerk is directed to terminate the motion pending at Dkt. 21.
FDA will issue Guidance by Friday.
Sentiment: Strong Buy
sleep tight longs...shorts your pain is just beginning...FTC is all up in this trading