RespireRx Pharmaceuticals Inc (RSPI)

[enemem]

In the CC, I hope someone raises the issue of why COR acquiesced to the FDA's ruling, when everything indicates that the FDA didn't even consider the data. If it is really the case that the decision was made before the data were seen, then somebody should put up a fight. People have been ruined, and a promising compound has been effectively killed. This is only getting worse because of the FDA's failure to provide anything in writing explaining the decision.

Could a FOIA request get us a transcript of the FDA's decision?

The flip side to this is that maybe COR rolled over because it knew about problems with the compound. For me this would be even worse.

Even if the FDA had an a priori objection to CX-717 for ADHD, they could have allowed the pIIb study to proceed while communicating with cor and its BP partners what benchmarks needed to be met in order to bring the drug to market. They could have set the benchmarks high, but in the absence of a scientific justification for killing the compound, what they did goes beyond the mandate of the FDA.