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Tag Archives: PPP002 Program

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Tetra Bio-Pharma’s PPP002 on Track After Type C Meeting with FDA

Tetra Bio-Pharma’s PPP002 on Track After Type C Meeting with FDA
Oct. 11, 2018 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), today announced it received the response letter for a Type C meeting with the United States Food and Drug Administration (FDA) for PPP002, its dronabinol AdVersa™ mucoadhesive product.   The meeting was held to confirm that the proposed chemistry and manufacturing and non-clinical development plan for PPP002 for the 505(b)(2) is acceptable.  
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Tetra Bio-Pharma Announces PPP002 Program Update Following Type B Meeting with U.S. FDA

Tetra Bio-Pharma Announces PPP002 Program Update Following Type B Meeting with U.S. FDA
Sept. 27, 2018 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), today announced that it conducted a Type B meeting with the United States Food and Drug Administration (FDA) for its dronabinol AdVersa™ mucoadhesive product, PPP002. The purpose of the meeting was to obtain confirmation of the eligibility of PPP002 for the 505(b)(2) NDA and the requirements for marketing approval.
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