RespireRx Pharmaceuticals Inc (RSPI)

[enemem]

>>4) Stoll handled the whole artifact process very well, in terms of using consultants to go through every permutation of possible FDA questions they could, in order to anticipate them and have responses ready. At the time, no one knew that Psychiatry was shutting down new drugs in treated disorders. Cortex turned out to be the canary in the mineshaft that was the alarm signal.

It could be argued that the resubmission of an ADHD IND (9/11/07) was a mistake. After the hold was lifted (July 07), and neurology had approved the PET scan study, CX-717 was (rightly) perceived as a clean compound. I think that at that point it would have made more sense to focus on life-threatening and/or orphan indications, such as paliative treatment for AZ, or for the dyspnea seen in Rett Syndrome. There are many things that remain very murky about the inactivation of the IND, but even if one accepts the most charitable interpretation, that the FDA killed the IND because the eventual target population was kids, because there were other drugs already approved, and because there was a hint (and nothing more than a hint) of a problem with CX-717, it begs the question of why the consultants hired by COR couldn't have gleaned psychiatry's intransigent position prior to the IND submission. My understanding is that the FDA stresses an interactive approach to developing INDs, so I still can't figure out how COR could have been so blind-sided by the outcome.
It can be argued that this is all 20-20 hindsight, but the problems with COR's approach were obvious: ampakines are a new class of compounds, and clinical trials simply can't pick out the 1/100000 that may respond badly to this new compound. Coming off the Vioxx debacle, the FDA's response seems to me to have been foreseeable. I fault management for not having recognized this.