- Completed its pre-IND meeting with the USA Food and Drug Administration for its PPP001 dried cannabis drug product
- Meeting was held in January 2017 with the Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research
- FDA provided all the necessary guidance on the design of the Phase I trial in healthy volunteers and the overall product development program, including quality, nonclinical and the medical device, and on marketing requirements
OTTAWA, ONTARIO–(Jan. 30, 2017) - PhytoPain Pharma Inc. (“PPP“), a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions announces that it has completed its pre-IND meeting with the USA Food and Drug Administration (“FDA”) for its PPP001 dried cannabis drug product. The meeting was held in January 2017 with the Division of Anesthesia, Analgesia, and Addiction Products (“DAAAP”), Center for Drug Evaluation and Research (“CDER”).
The FDA provided all the necessary guidance on the design of the Phase I trial in healthy volunteers and the overall product development program, including quality, nonclinical and the medical device, and on marketing requirements. Dr. Chamberland, M.Sc., Ph.D., Chief Scientific Officer and Regulatory Affairs, commented “We could not be more pleased, as the FDA guidance gave us a clear path to progress from early to late phase clinical development. Adhering to the US FDA regulations is part of Tetra Bio-Pharma’s dedication to the commercialization of Cannabis as a prescription controlled drug and the corporations plan to seek reimbursement by insurers for patients.”
The Canadian Securities Exchange (“CSE”) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.
Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.
Tetra Bio-Pharma Inc.
Dr. Guy Chamberland
Chief Science Officer
Tetra Bio-Pharma Inc.
Chief Executive Officer