RespireRx Pharmaceuticals Inc (fka RSPI)

[neuroinv]

Getting Fast Track has no meaning at this stage whatsoever.

I'm sure that they've thought about Fragile X, since Berry-Kravis did the CX516 study. My guess is that they concluded Fragile X would be better served by a high-impact.

<<something rare, something baffling, something neurological!>>

Something they can be reasonably sure CX-1739 would work in is more to the point--and Fragile X is not yet in that category. Add in the fact that Novartis, Roche, and Seaside Therapeutics are running Phase II or III trials for Fragile X now: With a rare disorder like Fragile X, that would be pose an enrollment problem for Cortex. The largest Fragile X trial ever completed was only able to enroll 65 patients.

Other orphan disorders--e.g. Huntington's--would very likely need a high-impact. And they can't go for really ultra-rare disorders (most of which would also probably need high-impacts)--it has to be a big enough patient population that a larger company would care enough to partner the drug. Roche and Novartis are hoping Fragile X is the gateway to autism--while Seaside has a Fragile X family which has given them $60 million to fund the company. Please don't say something really dumb like--"Why can't Cortex find a family to give them $60 million?!!"

There is no disorder for which they have a higher probability of showing success in Phase II than ADHD. That's why they chose it.

NeuroInvestment