"Opting to not orally argue at a hearing and submitting on the briefs is no indication (ZERO) of the merits of the case."
I agree with you...except the FDA has no Merits to argue, Amarin has showed the FDA has played both sides of the fence. In 2009 it's definitely a NCE only to wax and wane after Marine and Anchor SPA's where successful...In addtion the FDA flat out denied the new NME/NCE policy it released the day after it's ruling on Amarin...
There's little doubt the FDA was "arbitrary and capricious", the Judge doesn't need to hear oral arguements but she does have to decide how far she wants to push her judgement.
IMO Amarin was calling attention to this ruling before Jenkins finalizes the FDA position on SPA rescinding.
The FDA has currently enacted a few new policy's related to NDA considered NCE, they are posted as new MAPPs at the FDA. One interesting change I would like to point out: NCE decisions have been moved to the priority list and up in the level they are decided. Also, There's a post approval review interview with an "outside company", interviewing both the company and the review team.
IMO Jenkins will also "rule" on NCE related to this new policy and perhapse our approval date will start at the date of the new policy 8-28-2014. Just hoping:) But the FDA needs a serious makeup call to put Amarin back on track to a justfied Marketshare.
Thanks for your opinion,
Today, NCE suit updated;
Simply an action by Amarin to highlight this is still open, wide open. The FDA doesn't want to argue in open court about this issue.
IMO FDA is actively attempting to negotiate SPA terms that are not up for negotiation. It's a SPA, Amarin fulfilled it's terms, the FDA broke the contract and materially damaged Amarin and stakeholders. In addition, the FDA ignored it's mission and withheld a safe effective treatment currently the NLA is proposing is a serious health risk for CVD and stroke risks.
" Notice of Availability for Oral Argument
The Court has pending before it the parties's cross-motions for summary judgement. Amarin has requested oral argument on it's motion. See L. Civ.R. 7(g). Defendants take the position that the motions can be decided without oral argument.
The parties have conferred regarding counsel's availability for oral argument and respectfully propose the following dates in the event that the Court elects to hear oral argument:
Monday Oct 27
Wednesday Oct 29
Thursday Oct 30"
The FDA is playing a very dangerous game with the wrong group of stakeholders.
Does nothing to assure FDA abides to REDUCEIT SPA...the FDA is arbitrary and capricious...nothing stops them from moving the bar. This is the point of SPA's, Congress needs to fix the FDA.
AZN has tested the IP waters...needed to be done to value the life cycle since the FDA has failed to act in a timely fashion.
I expect the rest of the week to be interesting.
It's a long holiday weekend;)
What about the Street?... SA, The Street, and Forbes have written agreements I believe to "share" the journalistic message. Anybody know?
Williams4076(Yahoo)BioBill (ihub) John Fuson and the FDA know me as Jason R Williams....really not hiding the facts.
Any truth to this? If so...I expect that a significant SEC investigation has turn over some rocks....finally. Yahoo would be liable for the damages perpetrated my these entities...including trade violations and Antitrust laws.
You need to get a brain transplant...please respond and wast your time...I'll never read it;). Ever!
Listen to me Linda....Without the FDA Standing 100% behind Anchor...REDUCE-IT is a waste of money!!! The FDA has to stand behind prior agreements...or future agreement can be consider nul. Do Not fall into the trap, well REDUCEIT will be respected!
Yet, I fear this is the driving force behind the American people being denied Vascepa/Icosapent Ethyl for the treatment of high triglycerides 200-500, for the past 2 years. Back in 2012 Vascepa should have been approved based on both the successful SPA studies Marine & Anchor. The FDA refused to consider Anchor data at the time of the Marine NDA review. The vial FDA attitude can be seen in the Marine NDA review.
Instead the FDA DEMANDED a multi $100 million dollar CVOT be undertaken and half enrolled before consideration of the Anchor data & Anchor sNDA application accepted.
We all are aware of what follows.
In a perceived victory Amarin and Investors "gained" the support of numerous politicians both Democrats and Republicans in both the House and the Senate. In the Markup and review of the FDA's 2015 budget both the House and the Senate demanded answers to the SPA rescission...Timeframe after the Fall Elections.
Cardiovascular disease isn't going to wait until the Fall elections to kill more Americans and spend Billions more in Health Care $$$'s. Americans want good, affordable, science based Health Care now!!!
Approve Anchor! Reinstate our SPA!
Americans for the ethical treatment of Cardiovascular Disease,
Williams/BB & All willing to send this message to every Congressional Member Today!
Join this fight, don't sit idle and let other fight this battle!
It's not exactly a secrete the FDA's "going" to through Amarin under the bus. Adam F was informed of this and how 2 years ago. If you really would like to know what's going on...is this FDA leak is getting exposed...that's what the birdie told me....someone's going to jail over this...
And if you think your anonymous posts can't be tracked... Light up another fatty and sit back and wait for it.
Starting yesterday, the FDA will be held accountable for increased Health Care costs related to CV events, HHS OIG needs to come up with a formula to fine the FDA for Medicare and Medicaid fraud, filing the complaint today.
By PDUFA law the FDA has no choice...they can delay...but I will make them pay.--Williams4076/BB/Jason
After the NEJM article, the FDA doesn't have a political or legal leg to stand on...yet they're standing.
Do we let the FDA soak on the "new science" or attack?