Amarin Corp Plc (AMRN)

[KCSVEN]

It's mainly the 1 FDA reviewer and as an extension of her the review team. She goes into great detail analyzing the placebo group and the mineral oil.

Her job was to research the data and find anything that would suggest they should not approve the drug.

The only thing she stated is that the placebo group results are atypical. She also states she finds no evidence that mineral oil is not inert. However, she exhausts all other options and thus wonders if mineral oil is as inert as FDA and others thought, if it is not then the results may be overstated(IF AND MAY). I don't see that as some huge FDA manipulation. I mean it was brought up in AMRN's CC a few months ago, she'd have to be a pretty bad reviewer to not look at that and throw the question out there. She's hypothesizing with very little scientific backing which is why the panel will likely dismiss, even AF says they will ignore the mineral oil argument.
But for her to decide the placebo group, to her, seems like the numbers should not have increased, and then to ignore mineral oil would be bad work.

People forget the review panel does not represent the FDA's point of view on the subject. The review panel for Adcomm has a different job than the people that finally approve the drug at PDUFA.

If the FDA is bought and sold the Adcomm could be unanimous Yes and FDA still vote no, they could just have skipped the Adcomm and then said they want to wait for Reduce It.