Replies to post #36014 on RespireRx Pharmaceuticals Inc (fka RSPI)

[sparkyone]

To add to my comments, she said she had never seen a more promising drug,but can't say anything more. My son is autistic, and she thinks ampakines are his best hope. Why not go after autism! So many subgroups they could certainly help.

[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