One possibllity that strikes me as not-all-that-plausible-but-still-possible is that Psychiatry never even looked into the six-foot box or only had time (and resources) to look at it rather cursorily, hence the non-approval of the IND, hence the inactivation of the IND, hence continuing discussions between COR and the FDA (wherein COR does not want to embarrass the FDA for not doing its job adequately), hence the continuing need of COR to keep these discussions out of public view.
Perhaps Neurology took the same tack, but since the IND with neurology only required short-term dosing, they could approve an IND in AD while Psychiatry could not, even though Neurology was no more able to do a full review than Psychiatry.
I offer this explanation, because it has always struck me that it would have been an impossible task for the underfunded, understaffed and overworked FDA to analyze the incredible amount of data that must be contained in the six-foot box in such a short time period. Psychiatry may have had no choice, really, but to not approve the IND until further review was possible. Publicly, they didn't want to admit that they couldn't get the job done. But, at the same time, they couldn't approve an IND that could prove to have "toxic" consequences for them. Sure, they took the CYA position. But did they really have any choice? (I suppose there must be some way to extend the IND process, when something like this pops up, but realistically it might not have been possible. Hence, maybe it was the FDA that suggested the "inactivation," until all the data in the six-foot box could be reviewed and the questions resolved.)
I doubt we'll ever know if this explanation has any real plausability, UNLESS the IND is reactivated, in which case, you can be sure that COR and the FDA were discussing the data in the six-foot box all along.
(Or maybe Psychiatry just said, "Fuck this, we're not going through all this data; just bring us a clean molecule." This might support my conclusion that CX717 is just a "stalking horse" for CX701 in AD, because Neurology is not going out on a limb, when Psychiatry refuses to do so. If CX717 shows some positive effects in the surrogate marker trials in AD, then bring on CX701, but don't ask Neurology to do what Psychiatry would not.)
Bladerunner
Bladerunner
