RespireRx Pharmaceuticals Inc (RSPI)

[enemem]

CX-717 wasn't rejected. The IND was inactivated by COR. We still don't know what happened there. According to others who are more knowledgeable about the regulatory process(and the FDA's own website), this outcome was anomalous: typically there is a back-and-forth between the FDA and the company about dosage and trial duration, which can extend the deadline for approval. In the case of CX-717, the axe fell exactly on the deadline, all on the basis of a phone-call which led to the inactivation.

As has repeatedly been discussed here, the anomalous process and the complete lack of transparency is subject to multiple interpretations. I think your view represents the consensus: that CX-717 is a flawed compound and was duly rejected by the FDA. To the extent that this is true, it raises issues about Stoll's credibility, since in the time leading up to the IND, we were told (at times explicitly), that cor had fully addressed the FDA's concerns (the famous 6' box). If the FDA found grounds to outright reject CX-717, how could cor have been unaware of the problems?

The alternative is that the process at the FDA was completely flawed. Supporting this argument is the lack of any documentation from the FDA regarding its decision. As the ombudsman at the FDA informed me though, an inactivation obviates the need for a written accounting.

Stoll has stated that he fully expects something in writing from the FDA. It is hard for me to imagine that the facts could be worse than the inference we're all making.

I keep going back to this issue because it highlights two issues that undercut the promise of the ampakine platform: questions about the company's own credibility, and the competence/honesty of the FDA.

COR should make every effort to get a written accounting from the FDA, and/or to be forthcoming about the problems with CX-717 that explain the inactivation.