Biotech Values

[biomaven0]

I agree caution is needed

Well, we are talking drug development and the FDA, so there will always be some measure of uncertainty.

But let me take you through how I see this as playing out:

They will come up with some endpoint for their randomized trial based on bone scan reduction/pain reduction with secondary endpoint OS. That primary endpoint is a clinical endpoint (unlike tumor progression) and so is enough for accelerated approval.

The trial will start and, assuming they get comparable results to these, will be quickly stopped early for efficacy. Nobody in the control arm who has already had docetaxel will show improvements on the primary endpoint, and so the DSMB will be quickly faced with a considerable favorable imbalance and will have little alternative but to stop the trial.

The FDA may be cautious, but they are not stupid, and I would expect a quick approval.

So there's my non-cautious take. :)

Peter