Biotech Values

[DewDiligence]

>>I thought Pazdur opposed accelerated approval processes.....how can he possibly help cancer patients by fighting accelerated approval....?<<

Pazdur’s contention (#msg-4881843) is that Subpart H Accelerated Approval ought to be precluded if there is already an approved drug for a given indication. However, there is no statutory authority for this viewpoint.

In the case of DNDN, whether they get an AA or a full-fledged approval is almost irrelevant from a practical standpoint.