Blade:
The studies that were required by the FDA when the hold was imposed included:
1) a full revisiting and reexamination of the old tissue samples from which the one in question had been obtained
2) primate 7 day maximum tolerated dose
3) rat 14 day maximum tolerated dose
4) Histological studies of those brave monkeys and rats
What Stoll was referring to was the fact that Cortex spent a lot of time, and money on FDA consultants, trying to anticipate what might be requested next, once all of that was submitted at the end of the summer. So there was "foresight"--they decided that another likely request was for three month tox work at higher doses. So they began them ahead of time, to have them in process IF the FDA asked for them. Which the FDA did. So, instead of scrambling to get them started now, which would meant the high-dose data would have been in by some time in February, they will have it before the end of the year.
And in response to the next question, what doses are in question, I don't know. I'm going to look through my notes to see if I can see what doses at what durations of time have already been done.
The bottom line is that this very good. Given the FDA's current stance, especially regarding ADHD drugs, its not surprising they gave Cortex another hoop to jump through. Had there been anything of concern in all the work Cortex did over the summer, the hold would not have been lifted now.
Companies were already getting back in queue to finish their due diligence assessments once Cortex had announced in mid September that the data looked clean. Now they can go full speed--three month tox testing of any relevant doses would have been necessary eventually anyways.
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