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BonelessCat

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BonelessCat

Re: loanranger post# 244928

Monday, 10/15/2018 7:43:21 PM

Monday, October 15, 2018 7:43:21 PM

Post# of 403017
There was not sufficient data to file a BTD request for OM or UP prior to the two proof of concept trials. That was my point. Your bolded text—“FDA expects that such evidence generally would be derived from phase 1 or 2 trials. Nonclinical information could support the clinical evidence of drug activity”—can’t be emphasized enough.

* Never borrow to invest.

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