I'm not assuming that--but I think the general consensus is that the current FDA climate is going to make it hard to find a dose that is high enough to affect hyperactivity, but is low enough for the FDA to accept a month of daily dosing.
If there was a leak, I wasn't in on it. Looking at the timing, I don't perceive a leak so much as people reading between the lines and deciding, correctly, that the hold was only partly lifted (there are some nuances in there in terms of the formal lifting of the hold making it much easier to now negotiate dosing informally, but it remains to be seen how important that will be). The dose limitations turned out to be more onerous than I had expected, and it appears, more onerous than Cortex had anticipated. That's another reason I describe the FDA as a 'moving target.'
My personal perspective? I think that raising money, while depressing the price and raising cries of 'dilution', will in fact be positive for Cortex and how it is seen--right now vultures are beginning to sniff at Cortex's cash position, which never enhances the perception. The monkey 3 month tox study is the key right now--and as I have said before, I am optimistic that there will be a viable dosing window--but I don't know that for sure, nor do I know whether the FDA will see it as large enough. But if you look at Blade and Gfp's recent posts on what Cortex retains as assets of value, I believe that the current price is far oversold. If the monkey data is clearly bad, it could go lower, though CX717 seems to have little value attributed to it at present. Like Blade, my largest holding is Cortex--and continues to be. If I didnt own Cortex, I'd buy it. But I have plenty, and I am holding on to it.
BTW--the flipside to the FDA's concern is--what about the drugs that patients must now utilize? Anecdotally-my wife, who is a clinical psychologist, received a call the other day from an ex-patient in Florida. His prescriber had made an error in changing his Adderall scrip--bottom line is that it increased by 2.5X. The result was that this high-functioning engineer went into an amphetamine psychosis, committed for three days to a county observation unit which sounded a lot like the 'snake pits' of old. 2.5X the previous dose. The FDA also has some obligation--and need--to not hinder the development of drugs safer than the ones out there, being used by millions.
That's another reason I am not giving up on Cortex.
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