Biotech Values

[poorgradstudent]

SRPT:

Quote:
I do think there is a lot of emotional pressure being applied to all respects of this decision.


Yah think?! <g>

I like to state the obvious

I agree we've seen odd approvals. But this SRPT package breaks so many of the guiding principles for drug development that I don't see the FDA approving. If they did, they'd either have to take outright capricious stands with other rare disease drug developers (there are rules for SRPT, and there are rules for you), or simply trash significant parts of their standard.

*If* the company gets approval and jumps in share price, I think it is a great short. Small population, and I think very high odds that any subsequent post-marketing trial fails as the drug clearly does not achieve its MOA.