RespireRx Pharmaceuticals Inc (RSPI)

[neuroinv]

I think I posted on this before, but here's one of several reasons I would not want to see Cortex take this on: To do the Phase IIb and Phase III trials to prove the worth of CX717 in acute/emergency RD, they'll have to prove it 'in the field', not in a controlled lab situation as Phase IIa was--and that turned out to be anything-but-controlled by the CRO. Given that the target event is relatively uncommon, and would become even less common in the more rigorously monitored climate of a clinical trial, waiting for enough cases to come through to generate enough of a database to establish superiority to naloxone will not be a rapid or inexpensive process. Maybe there'd be some alternative that the FDA would buy--one does not occur to me at the moment.

I don't think the FDA is corrupt. The problem is not corruption, it is finding the fine line between conservatism and cowardice.

NeuroInvestment