Not unless the proposed trial length exceeds the length of continuous exposure used in the original Phase I trial--was that 2 weeks? I don't have time to look, I go to press tonight. Too bad Gfp trashed those notebooks, he would have had the answer there.
Generally the rule of thumb is that you don't go beyond the time established as safe by animal tox trials (up to a max of one year). The FDA could in theory--though I do not recall this ever having been done offhand--require extended human safety trials if Cortex wanted to go to longer administration periods, especially for Alzheimer's, where you'd prefer six months exposure. But since no behavioral/physiological changes are seen, its not clear what they'd even look for.
In sum--they could in theory add more human safety testing to the usual animal tox escalation if and when Cortex were to go to longer trials.
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