Biotech Values

[AlpineBV_Miller]

Pazdur already has gone beyond Congressional rules and requires a confirmatory trial be "substantially under way" before he will allow OOD/ODAC to consider accelerated approval.

For randomized trials, this usually now takes place in a very large single trial with a surrogate interim and OS as the final endpoint. Interestingly, this has resulted in two drug approvals where the 2-in-1 trials never generated prospective survival data (Nexavar and Sutent) because the trials were halted and drug was offered to placebo patients before the survival readout could be made.

For single-arm trials, the requirement is the confirmatory needs to be "substantially" under way. If a company decide to take him to court on this one, he'd lose. But I doubt any of them will.

This means in some way's ODAC was just blustering. More of his grandstanding.