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Ampio Pharmaceuticals Inc Receives FDA Acceptance Of Patient Outcome For Premature Ejaculation (POPE) Questionnaire

Monday, 11 Mar 2013 04:00am EDT 

Ampio Pharmaceuticals Inc announced FDA acceptance of POPE questionnaire, a modification of the Premature Ejaculation Profile (PEP) questionnaire that was used in the two Zertane Phase 3 clinical trials completed in Europe. The completion of this trial and acceptance of the POPE by the FDA allows Ampio (or a pharmaceutical partner) to file an IND in the USA for a pivotal trial of Zertane with POPE as a co-primary end-point along with Intravaginal Ejaculatory Latency Time (IELT). 

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14 Jun 2013