Brief: Ampio Says FDA Does Not Consider Data From AP-013 Sufficient To Demonstrate Efficacy As Second Pivotal Trial

Ampio Pharmaceuticals

16/05/2022 21:34

May 16 (Reuters) - Ampio Pharmaceuticals Inc  AMPE.A :
    * AMPIO INDEPENDENT COMMITTEE TO CONDUCT INVESTIGATION
    * AMPIO- FDA HAS COMMUNICATED TO CO IT DOES NOT CONSIDER
DATA FROM
AP-013 TO BE SUFFICIENT TO DEMONSTRATE EFFICACY AS A SECOND
PIVOTAL TRIAL FOR AMPION
    * AMPIO PHARMACEUTICALS INC - AMPIO BOARD OF DIRECTORS ALSO
HAS
BEGUN A PROCESS TO CONSIDER STRATEGIC ALTERNATIVES FOR AMPIO AND
AMPION
    * AMPIO PHARMACEUTICALS INC - COMMITTEE ALSO IS OVERSEEING A
REVIEW OF UNAUTHORIZED USE OF AMPION BY INDIVIDUALS NOT
PARTICIPATING IN CLINICAL TRIALS
    * AMPIO-INDEPENDENT SPECIAL COMMITTEE OF CO'S BOARD, WITH
ASSISTANCE OF INDEPENDENT LEGAL COUNSEL, IS IN PROCESS OF
CONDUCTING INTERNAL INVESTIGATION
    * AMPIO PHARMACEUTICALS INC - INTERNAL INVESTIGATION RELATES
TO,
AMONG OTHER MATTERS, AMPIO'S AP-013 CLINICAL TRIAL AND OTHER
CLINICAL TRIALS
    * AMPIO- RECENT ANALYSES ALSO INDICATE NO CLINICALLY
MEANINGFUL
TREATMENT EFFECT SIGNALS FROM CO'S 3 COVID-19 CLINICAL TRIALS,
AP-017, AP-018, OR AP-019

Source text for Eikon:  ID:nPn8Rz7yMa 
Further company coverage:  AMPE.A 

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