Wednesday, October 23, 2013 8:43:27 AM
JL, I've seen the light
Upon further review and consideration, I've concluded it is in the best interest of the firm to be aggressively seeking recourse through legal action - immediately.
There has indeed been material harm done to the company by the FDA
The move by Amarin to reduce expenses is not about survival, it to ensure there are sufficient funds to support the efforts of its counsel, which if you remember is very experienced in litigating matters pertaining to the FDA. I expect filings are being prepared without hesitation.
Amarin did everything it was asked of it by the FDA. The drug has met all the endpoints and its safety profile unmatched, even compared to OTC products such aspirin.
The FDA had so badly botched the ADCOM process and in doing so telegraphed its true intent, that consequence to Amarin was catastrophic and of measurable material harm.
The liability of the FDA at this juncture is significant. We as shareholders would be best served to help illuminate the disservice done by the FDA to the public it serves, the questionable grounds for its purposeful and obvious manipulation of the ADCOM process to force the only possible outcome by limiting rebuttals and crafting unanswerable questions, ignore current science, and in doing so negatively impacted the lives of millions of Americans who will suffer needlessly by being denied access to Vascepa.
Upon further review and consideration, I've concluded it is in the best interest of the firm to be aggressively seeking recourse through legal action - immediately.
There has indeed been material harm done to the company by the FDA
The move by Amarin to reduce expenses is not about survival, it to ensure there are sufficient funds to support the efforts of its counsel, which if you remember is very experienced in litigating matters pertaining to the FDA. I expect filings are being prepared without hesitation.
Amarin did everything it was asked of it by the FDA. The drug has met all the endpoints and its safety profile unmatched, even compared to OTC products such aspirin.
The FDA had so badly botched the ADCOM process and in doing so telegraphed its true intent, that consequence to Amarin was catastrophic and of measurable material harm.
The liability of the FDA at this juncture is significant. We as shareholders would be best served to help illuminate the disservice done by the FDA to the public it serves, the questionable grounds for its purposeful and obvious manipulation of the ADCOM process to force the only possible outcome by limiting rebuttals and crafting unanswerable questions, ignore current science, and in doing so negatively impacted the lives of millions of Americans who will suffer needlessly by being denied access to Vascepa.
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