I was actually speaking generically--and indeed said IF there were specific issues raised in the FDA's letter. And if there were, some additional possible (in theory) reasons to withhold them. I don't expect any, we are in agreement on the bottomline. The conundrum is: If there is no real substance to the rejection, and the letter really is just vapor, disclosing it in all of its vapidity might be embarrassing for the FDA.
To be frank--every primitive instinct I have says **** the FDA, let's expose them for the incompetents they are. The same social skills that occasionally leave me having to regret something I posted here. The stakes of course are much higher for Cortex, and they will not ask my counsel, nor will I offer it.
I'd like to see the letter as much as anyone. But I do not recall any company in the twelve years I have followed the sector releasing such a communication from the FDA. My point was that there could be valid reasons for not doing so, beyond those posited by Aiming4.
Finally: Be careful when assuming that the FDA would discriminate pressure coming from Cortex shareholders as opposed to pressure emanating from Cortex itself. They'd probably assume it was company-initiated.
If shareholders really want to have pressure applied, they are the wrong group to do it. It would have to be prescribers and patient families.Working through a patient advocacy group like CHADD would be the best way, because congressmen hearing from dozens of p--- moms is much more effective than hearing from people annoyed at the stock price. The problem is that this is much more do-able when there is no treatment available. I can half-imagine trying to sell parents/prescribers on the concept of an ADHD drug that might affect the disorder itself, not just mask it--but there is only a preliminary hint of that in the data. Couple that with parents not being interested in any portent of a safety issue, and I think galvanizing CHADD is not a high-probability enterprise.
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