PINL:GRPOF - Post by User
Comment by
indaknownewfieon Oct 11, 2018 10:08pm
155 Views
Post# 28785759
RE:Ppp002 On Track After Type C Meeting With FDA
RE:Ppp002 On Track After Type C Meeting With FDAalphatradr wrote: Oct 11 (Reuters) - Tetra Bio Pharma Inc: 10/11/2018 6:41 AM ET
* 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
If i could give you more stars I would