Janet Woodcock stated Vascepa should take DS route, and this is how CDER views the $250 million Amarin has spent on R-I clinical trial. It further adds injury to the insult of October 16th Ad Com which slandered R-I with mineral oil and foreshadowed the agencies intent to rescind ANCHOR creating the possibility of R-I rescindment. This destroyed the stock in case you haven't been paying attention.
B......The goal of DS is not to make outright lies, which could be easily dealt with..... but to make vague, unproven, and misleading statements, which are harder to deal with.....and which muddy up the waters and promote sales of their product to a confused public.
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