What I don't get is why Stoll, during the CC more or less said "we still haven't received anything in writing..", instead of "we're not going to receive anything in writing".
If all this were above-board, as Neuro believes, why didn't Stoll say it like it was? Did he not know that by inactivating the IND he was precluding a written explanation? I'm convinced he fully understood the implications of inactivation, particularly wrt the removal of the FDA's required written response.
Another problem I have is that the IND process, according the the flow-chart at the FDA's website, is supposed to be interactive, with the FDA raising concerns, and the company coming back with alternatives/explanations/etc. Cor made a substantial investment of time, resources, and manpower to prepare CX-717 for its IND submission. It just doesn't make sense to me that they'd just flop if the compound was as clean as we were led to believe in earlier CCs. What one would have expected is at least some back-and-forth between the FDA and COR in an effort to work out some kind of compromise. This is particularly the case because COR's management had to have known that a negative ruling would crater the SP.
My conclusion is that COR's 6' box contained data that COR had every reason to believe would lead to another hold. By caving, they kept alive the alternative explanation that the FDA was just operating in CYA mode. This is the only explanation that renders Stoll's intention of going forward with CX-701 for ADHD at least half-way comprehensible: if the FDA's ruling was merely based on ADHD as the wrong indication for a new compound (young healthy patients; other meds; non-life-threatening;...), then why would Stoll plan on submitting another new compound for the same radioactive indication?
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