There's been all this talk about an unfavorable AMRN Anchor adcomm meeting next month based on a delay until Reduce It results become available in 2016. The shorts, bashers and likes of AF and SA have made this their "trump card" heading into October. This point of view forced me to do a little bit of research on these meetings. As most of you know, these are conducted by a group of subject matter experts in research, pharmacology, clinical setting and PhD level statisticians. Their goal is to review the merits of the application and evaluate the drug (Vascepa) for achieving endpoints, safety and efficacy - period.
My point is this: when did these individuals decide it's within their scope of review to render an opinion or recommendation on a previously agreed upon SPA between the drug manufacturer and FDA? I did some research and couldn't find a past example. This is beyond their scope. If anyone could provide an past example of when such a recommendation was made, please post the example: date of adcomm, drug, outcome.