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

Published 2018-09-27, 06:35 a/m
© Reuters.  BRIEF-Tetra Bio-Pharma Announces PPP002 Program Update Following Type B Meeting With U.S. FDA

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

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