Biotech Values

[mcbio]

Re: ZIOP

Aren’t we saying essentially the same thing? If the FDA does not trust the PFS results from phase-2, they may be disinclined to issue an SPA for a phase-3 trial whose design is essentially a clone of phase-2.

I'm suggesting that given its skepticism with the open-label Phase 2 results, perhaps the FDA will still consider PFS as a primary endpoint in a SPA, but its requirements regarding PFS are much more robust (perhaps lower HR as turtle is suggesting) than what ZIOP originally anticipated.