Biotech Values

[biomaven0]

If the panel was only concerned with the size of the trial, then the FDA could indeed overrule and approve with a requirement for a Phase IV trial. Likely the company consulted with the FDA on the size of its trials, so such an approval wouldn't be out of the question.

I doubt the company could afford another big (5k) trial if that's what the FDA wants. At this point we still have European approval as a real possibility that could partially rescue the company.

I know of an analyst that suggested betting against the company prior to the panel because in his view the panel was full of GSK and Merck collaborators. I thought that was a paranoid view given the benign briefing document, but maybe he was in fact on to something.

Peter