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Friday, August 01, 2014 9:37:03 AM
This is a very positive letter. The FDA reiterates the fact that by federal law they can not discuss AMRN's pending application or the CPs.
Then comes the "meat" of the letter.
"Please know the FDA is aware of significant congressional and shareholder interest in th agencies (sp) decision on this matter. FDA is making every effort to resolve the matter as expiditiously as possible while also ensuring that the Agency's decision reflects a full consideration of issues brought to our attention in light of all available scientific evidence."
Wow..Rest assured congressional interest is not on how to reward the FDA for their actions regarding the SPA.
The letter states the FDA is making every effort to resolve the matter ensuring that the Agency's decision reflects a full consideration of issues brought to our attention in light of all available scientific evidence. What could be the "issues brought to our attention in light of all available scientific evidence?"
There is no recent evidence condemming EPA. What there is, is a tidal surge of scientific evidence that the FDA clearly ignorred in the Oct 2013 meeting..That is all the evidence regarding the anti inflammatory actions of EPA, the population studies, JELIS and the recent evidence provided by the NEJM APOc3 paper. What also is clear is that the FDA argued using twisted scientific evidence contained in flawed clinical trials using APIs which are only tangentially related to EPA. This is giving these drugs Niacin and Fen fibrate the most generous of interpretations. Actually these two drugs are toxic.
IMO the FDA will reinstate the SPA in the very near future...Going to court over this would be insane.
":>) JL
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