Tetra Bio Pharma Inc (TBPMQ)

[PotterBanker]

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

wtf?

https://globenewswire.com/news-release/2018/10/11/1619796/0/en/Tetra-Bio-Pharma-s-PPP002-on-Track-After-Type-C-Meeting-with-FDA.html

October 11, 2018 06:30 ET | Source: Tetra Bio-Pharma Inc

ORLEANS, Ontario, 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.

The FDA established that Tetra Bio-Pharma’s proposed bridging strategy fulfilled all the requirements of the 505(b)(2) regulatory pathway for the product PPP002. The FDA also provided feedback on the chemistry and manufacturing aspects of the drug development plan. The FDA further confirmed that the product control strategy, ensuring the identity, potency, purity and quality of the PPP002 buccal tablets was acceptable thereby determining that Tetra Bio-Pharma’s plan is on track for drug approval.

"We have now completed our meetings with the U.S. FDA and Tetra is well on its way to finalizing the development plan to bring PPP002 to market,” said Guy Chamberland, M.Sc., Ph.D., Interim Chief Executive Officer and CSO of Tetra Bio-Pharma. “With both the Type B and C meetings now behind us, we are able to move forward with executing the clinical program for PPP002 and subsequently submit the New Drug Application to commercialize PPP002."