Biotech Values

[DewDiligence]

I find it somewhat uncomfortable that these huge companies are not fulfilling the FDA data needs upfront.

The denosumab BLA is one of the most complex applications the FDA has ever had to consider (see the table in #msg-41722030), and hence the FDA’s not granting approval by the PDUFA date does not reflect badly on either the FDA or AMGN, IMO.

Based on today’s AMGN PR, FDA approval for treatment of osteoporosis appears to be in the bag, but approval for prevention of osteoporosis requires additional clinical trials. This split outcome is consistent with the advisory panel’s voting in August.