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Regarding Vascepa sNDA REDUCE-IT indication:

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Biobillionair Member Level  Tuesday, 02/12/19 08:32:12 AM
Re: None
Post # of 177258 
Regarding Vascepa sNDA REDUCE-IT indication:

The "delay" in filing the sNDA is on the FDA for not addressing the DS Omega industry at the time of Amarin's ITC case filing.

What's taking the Federal Circuit Court so long? Reading the history between Amarin and the FDA is a formidable task; after which the Court must render a just opinion. There is no way to frame a just opinion without the complete unraveling of the abuse of power directed at Amarin, Vascepa, and stakeholders.

I think it's vital for the FDA to paint themselves in the best light prior to the ITC coming forward with a just opinion regarding the FDA's choice of NOT following Code of Federal Regulations and controlling the supplement industry. Further, the involvement of Congressional meddling in the case likely warrants an independent HHS OIG investigation of Congressman Frank Pallone.

I'm not sure when we see the ITC ruling, but my gut tells me it's not going to favor two Agencies that refused to do their respective jobs. This is LITERALLY a breach of Constitutional "Due Process". The ITC case IMO opens a damages phase which at this point the FDA can't avoid. I think this phase will be organized and quiet with Amarin being justly awarded future drug accelerated program certificates...think AMR 103 drug development program.

BB

I do not pump Amarin stock. I am not an Amarin cheerleader. If I see something I don't like I make it known. Patients come first, always!!!
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