RespireRx Pharmaceuticals Inc (RSPI)

[enemem]

I'm not sure that the investment community has the attention span to care, but there might also be something in the FDA's letter that would help cor with damage control. The spring/summer surge in cor's sp was based on the high level of confidence expressed by cor's management (Stoll in particular) wrt to cx-717's chances in phIIb for ADHD. The inactivation on 10/11, without any evidence for negotiations (which would have delayed the announcement date), and as a de facto rejection rather than a rejection via infeasably tight constraints on experimental design (which would perhaps have allowed cor to save face and credibility), all raised questions about cor management's competence or (worse still) their trustworthiness.

If the FDA's rejection (as I suspect) was due to nothing more than their unwillingness to approve a trial for a new class of drugs for the chronic treatment of a non-life-threatening pathology affect primarily young adults, then the letter will contain no proprietary information useful to cor's competitors. It's not obvious to me why cor's management would not disseminate this information, since it would lay to rest the doubts raised above, and if the FDA has stewed on this for 6 months, you'd want to believe that they'd be willing to stand by what they've written.

Unfortunately, if we are left in the dark, there is no obvious interpretation. On one hand it might just reflect cor's unwillingness to risk pissing off the FDA; on the other, it could be that the letter is more substantive, and hence contains proprietary inofrmation.

I don't have a feel for how sensitive the FDA is, or how common the practice is of disseminating the contents of these types of letters, so I can't weight these two outcomes. Still, for me no news would be somewhat bad.

On the topic of "piss off the FDA", it may be that communicating with legislators on the eve of a congressional hearing about the FDA's policies might not be a bad thing at all for shareholders to undertake. The ADHD media and politicos may (for five seconds) actually take notice of this story. It pressures the FDA without involving cor.