Lidopete: QUOTE " Once FDA and a sponsor enter into a SPA agreement, there are only two statutory bases for changes to the SPA: 1) written agreement between FDA and the sponsor or 2) where FDA finds a “substantial scientific issue essential to determining the safety or effectiveness of the drug” that is identified after the trial has begun."
The safety issue for Vascepa was never in question....IMO it was a stretch for the FDA to say that studies done on unrelated drugs with patient populations, unlike than the R-IT population, should be held up as a criterion to pre-judge a failure of efficacy in the case of Vascepa.....The FDA was wrong at the Adcom in 2013, both in the way they manipulated the Adcom with a predetermined goal to deny Anchor approval, and their flawed reasoning for the disapproval.
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