Biotech Values

[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.