Brief: Tetra Bio-Pharma Announces PPP002 Program Update Following Type B Meeting With U.S. FDA

Tetra Bio Pharma

27/09/2018 11:35

Sept 27 (Reuters) - Tetra Bio Pharma Inc  TBP.V :
    * TETRA BIO-PHARMA ANNOUNCES PPP002 PROGRAM UPDATE FOLLOWING
TYPE
B MEETING WITH U.S. FDA
    * TETRA BIO PHARMA INC - SHORTER REGULATORY PATHWAY
CONFIRMED BY
FDA AND POTENTIAL FOR SCHEDULE 3 CLASSIFICATION
    * TETRA BIO PHARMA INC - FDA CONFIRMED ELIGIBILITY OF
505(B)(2)
REGULATORY PATHWAY FOR PRODUCT PPP002
    * TETRA BIO PHARMA INC -  ANTICIPATES SUBMITTING A NEW DRUG
APPLICATION TO COMMERCIALIZE PPP002 IN Q1 2019
    * TETRA BIO PHARMA INC - IN MEETING, FDA ALSO PROVIDED CLEAR
GUIDANCE ON SAFETY AND DRUG ABUSE DATA REQUIREMENTS FOR NEW DRUG
APPLICATION

Source text for Eikon:  ID:nGNX9wC8Yw 
Further company coverage:  TBP.V 

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