Biotech Values

[DewDiligence]

Re: FDA wants more data on Xarelto

Hardly any FDA applications get outright approval by the PDUFA date these days, so a CR Letter with no demand for new trials is a good outcome for JNJ and Bayer, IMO.

Given the less than completely clean safety profile (#msg-36360107), the questioning of the efficacy endpoints by some panelists (#msg-36415556), and the way the advisory panel spent 45 minutes worrying about potential off-label use (#msg-36474892), the FDA might have requested additional safety data that would have delayed approval by a year or more.