Replies to post #45002 on Biotech Values

[iwfal]

With a little effort, you should be able to answer your question—at least for the period from 1993 to the present.

You could have just said either "I don't know" or "it hasn't happened". I was asking hoping to bypass the 10 hours of work it would take to do it myself.

My guess is that it is an extremely rare event - in the 1 in 20 or less class - just as it is for other ACs.

[exwannabe]

>>This ODAC reference document goes back to 1993

Working my way backwards, out of the first 14 yes votes only 1 drug (UFT) was not approved.

Approvals were generally within 1-2 months. One drug (Bexxar) was delayed several months for more safety data that the company mentioned to the AC,. but had not previously supplied to the FDA.

The failed drug, UFT, was actually pulled by the company (Brystol Myers). The issue was some requested data concerning combination useage that the FDA had requested, but BMS supplied to late for the AC to review (so the FDA never even asked the AC about this concern). It was also the case that the SOC changed in the meantime, maybe this complicated the issue.