Replies to post #85215 on Biotech Values

[genisi]

Another one that got delayed by the FDA is ENDP's testosterone gel - fortesta:

http://www.reuters.com/article/marketsNews/idCNBNG50540420091019?rpc=44

[dewophile]

FDA climate

my overall impression is that until this recent spate of rulings the FDA's cautionary stance post-vioxx had actually ebbed somewhat. one thing to bear in mind is that all these drugs are for indications for which there are existing therapies - so the bar should be higher. as for MNTA specifically, if you think the FDA is getting more gunshy then it can cut both ways - on the one hand delay approval of any generic, and on the other set a higher bar that only MNTA can cross, leaving it as a sole generic

[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.