Brief: Tetra Bio-Pharma’S Ppp002 On Track After Type C Meeting With FDA

Tetra Bio Pharma

11/10/2018 11:41

Oct 11 (Reuters) - Tetra Bio Pharma Inc  TBP.V :
    * TETRA BIO-PHARMA’S PPP002 ON TRACK AFTER TYPE C MEETING
WITH FDA
    * TETRA BIO PHARMA - FDA ESTABLISHED CO'S PROPOSED BRIDGING
STRATEGY FULFILLED ALL REQUIREMENTS OF 505(B)(2) REGULATORY
PATHWAY FOR PRODUCT PPP002
    * TETRA BIO PHARMA - FDA ESTABLISHED THAT CO'S PROPOSED
BRIDGING
STRATEGY FULFILLED ALL REQUIREMENTS OF 505(B)(2) REGULATORY
PATHWAY FOR PRODUCT PPP002
    * TETRA BIO PHARMA INC - FDA ALSO PROVIDED FEEDBACK ON
CHEMISTRY
AND MANUFACTURING ASPECTS OF DRUG DEVELOPMENT PLAN
    * TETRA BIO PHARMA - RECEIVED RESPONSE LETTER FOR TYPE C
MEETING
WITH U.S FDA FOR PPP002, ITS DRONABINOL ADVERSA MUCOADHESIVE
PRODUCT
    * TETRA BIO PHARMA INC - FDA CONFIRMED PRODUCT CONTROL
STRATEGY,
ENSURING IDENTITY, POTENCY, PURITY AND QUALITY OF PPP002 BUCCAL
TABLETS WAS ACCEPTABLE

Source text for Eikon:  ID:nGNX3Xjp2N 
Further company coverage:  TBP.V 

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