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Re: ZincFinger post# 79163

Tuesday, 01/28/2014 11:26:20 AM

Tuesday, January 28, 2014 11:26:20 AM

Post# of 146240
ZincFinger, Thanks. I have two more questions

(1) It seems from your answer that when the drug toxicity is very low, FDA may not require TOX studies in multiple animals. Is this correct?

(2) Once FDA approves clinical trials, will the compnay have to get further FDA approvals after each phase is complete? Or is it that if each phase achieves its objective, the next phase can be started without delay? As far as I know at least FDA consultation after each phase is required. If FDA approval is required after each phase it will add long time between the trials since FDA takes a huge amount of time to decide. NNVC trials themeselves may be short, but collecting all the data, properly analyzing it and FDA consultation will add much longer time than the trials themselves.

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