Brief: Ampio Provides Regulatory Update

Ampio Pharmaceuticals

20/04/2022 23:04

April 20 (Reuters) - Ampio Pharmaceuticals Inc  AMPE.A :
    * AMPIO PROVIDES REGULATORY UPDATE
    * AMPIO- RECEIPT OF WRITTEN RESPONSES FROM FDA  PURSUANT TO
A TYPE
C MEETING REQUEST SUBMITTED BY CO EARLIER IN YEAR REGARDING
AP-013 TRIAL RESULTS
    * AMPIO PHARMACEUTICALS - FDA RESPONDED THAT IT DID NOT
AGREE WITH
COMPANY'S PROPOSED CHANGE FROM ITT POPULATION TO MITT POPULATION
FOR PRIMARY ENDPOINT
    * AMPIO - FDA STATED IT DID NOT AGREE AP-013 COULD SERVE AS
SECOND
PIVOTAL TRIAL FOR AMPION BASED ON BOTH CHANGE IN ANALYSIS
POPULATION & ANALYSIS OF PAIN ONLY INSTEAD OF ORIGINAL
PRESPECIFIED CO-PRIMARY ENDPOINTS
    * AMPIO PHARMACEUTICALS INC - GIVEN POINTS IN FDA'S ANSWER,
IT
WILL BE VERY DIFFICULT TO SALVAGE AP-013 ITSELF AS A PIVOTAL
TRIAL
    * AMPIO PHARMACEUTICALS - AT THIS POINT, BELIEVE BEST PATH
FORWARD
FOR AMPIO AND AMPION IS LIKELY CONDUCTING A NEW PHASE 3 TRIAL
    * AMPIO - BELIEVE WE ARE POSITIONED TO DESIGN & EXECUTE A
TRIAL
THAT CAN LEAD TO BLA APPROVAL FOR AP-013

Source text for Eikon:  Pn6P7nxRa 
Further company coverage:  AMPE.A 

 ((Reuters.Briefs@thomsonreuters.com;))