Replies to post #13916 on RespireRx Pharmaceuticals Inc (RSPI)

[ampakineman]

I know this is 20/20 hindsight, but has anyone wondered about the 'wisdom' of submitting a 6ft box of data to an understaffed FDA?

This, in hindsight, may cast some doubt on the 'quality' of the FDA consultants that COR used....and might point to a more cautionary approach the next time.

[madatid]

The reasoning (which I kick myself for not appreciating earlier) is that Psychiatry did not need to go through the entire 6 feet in order to reach what they believe is the right conclusion: i.e the tissue artefact, while only present after fixation, was never observed in untreated animals (Stoll's words in the post mortem CC) and therefore reflects some underlying, poorly understood biology which we are not willing to take a chance on in a non-life threatening disorder for which there are other at least somewhat effective therapies. Now if COR understood why there was this artefact after CX717 treatment and could say this innocuous change was responsible, that would have been a different story. Not so. End of CX717 in ADHD, imo.