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Tetra Bio-Pharma Confirms Regulatory Strategy of Lead Product CAUMZ™ and Strengthens Management Team
Tetra Bio-Pharma Confirms Regulatory Strategy of Lead Product CAUMZ™ and Strengthens Management Team.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\n OTTAWA, Nov. 11, 2019 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc., (TSX-V) (OTCQB: TBPMF), a leader in drug discovery and development for cannabinoid-based therapeutics, today confirmed its regulatory strategy of its CAUMZTM (PPP011) inhalation drug product and provided additional updates on its progress with U.S. Food and Drug Administration (FDA) for an expedited review. Additionally, the company provided updates on its plans and preparations for commercial launch of CAUMZTM, which include the appointments of key strategic personnel. “Tetra’s regulatory team has made tremendous progress and we are pleased to confirm our regulatory strategy of CAUMZTM.  Our clinical development strategy to date has been aimed at addressing all of the requirements of the Food and Drug Act and obtaining FDA approval for CAUMZTM-Kit,” commented Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma Inc.  \"To that end, we have taken the care to address all of the regulatory requirements in our Type B meeting with the FDA and look forward to providing additional clarity as we receive confirmation from the FDA on our final development plan.” Dr. Chamberland continued, “As we prepare to continue our clinical development work based on the feedback from the FDA, we are also preparing for commercialization and launch of CAUMZTM.  This work requires we diligently prepare our manufacturing facilities, which includes scaling up to manufacture commercial batches of CAUMZTM and submitting commercial applications to the proper authorities in order to be ready to launch upon potential approval. As part of our strategic plan, we have added key personnel to important commercialization roles. I am pleased to welcome Dr. Melanie Kelly in the role of Chief Scientific Officer for Tetra.  Melanie brings tremendous experience and will be instrumental in helping develop CAUMZTM. Additionally, I am thrilled to announce Steeve Néron has assumed the role of Chief Operating Officer after formerly having served as Senior Vice President of Marketing and Medical Affairs for Tetra.” “We are diligently preparing for commercialization, with the appointments of key personnel, preparations in our manufacturing capabilities and plans on the regulatory front.”  Mr. Chamberland concluded...