Brief: Tetra Bio-Pharma Announces PPP003 Program Update Following Type B Meeting With U.S. FDA

Tetra Bio Pharma

17/06/2019 11:58

June 17 (Reuters) - Tetra Bio Pharma Inc  TBP.V :
    * TETRA BIO-PHARMA ANNOUNCES PPP003 PROGRAM UPDATE FOLLOWING
TYPE
B MEETING WITH U.S. FDA
    * TETRA BIO PHARMA INC - FDA CONFIRMED PROPOSED QUALITY
INFORMATION REQUIREMENTS FOR INITIATING PHASE II TRIAL IN
PATIENTS.
    * TETRA BIO PHARMA INC - FDA ALSO PROVIDED FEEDBACK ON GLP
TOXICOLOGY REQUIREMENTS TO INITIATE PHASE II TRIAL.
    * TETRA BIO PHARMA INC - FDA ALSO PROVIDED GUIDANCE ON
ACCEPTABLE
PRIMARY AND SECONDARY ENDPOINTS.
    * TETRA BIO PHARMA INC -  FDA AGREED THAT IT WAS ACCEPTABLE
TO
EVALUATE SAFETY AND EFFICACY OF PPP003 OPHTHALMIC SOLUTION

Source text for Eikon:  ID:nGNX68CvCd 
Further company coverage:  TBP.V 

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