TBP:CC - Tetra Bio-Pharma Cancels New Drug Submission to Health Canada
(TheNewswire)
MONTREAL, QUEBEC – TheNewswire– May 11, 2023 -- Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP)(OTC:TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discoveryand development, today announced it hascancelled its New Drug Submission (NDS) to Health Canada, withoutprejudice to a refiling once it has completed a new clinical trialthat addresses deficiencies raised by the regulator.
The NDS was intended to seek marketing approval inCanada for REDUVO™, a therapy for chemotherapy-induced nausea andvomiting. Health Canada’s review of the NDS raised issues regardingthe submitted Phase 1 clinical and analytical data that had beenperformed more than 15 years ago. Clinical research standards haveevolved since the conduct of the trial and Health Canada questioned ifthe trial would meet today’s standards for drug approval.
The Company assessed the regulatory risk of maintainingits NDS in a revision status. By cancelling the application, theCompany will be able to resubmit without prejudice.
About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma (TSX: TBP) (OTC-PINK: TBPMF)(FRA:JAM1) is a leader in cannabinoid-derived drug discovery anddevelopment with a FDA and a Health Canada cleared clinical programaimed at bringing novel prescription drugs and treatments to patientsand their healthcare providers. Tetra's evidence-based scientificapproach has enabled them to develop a pipeline of cannabinoid-baseddrug products for a range of medical conditions, including pain,inflammation, and oncology. With patients at the core of what they do,Tetra is focused on providing rigorous scientific validation andsafety data required for inclusion into the existing biopharmaindustry by regulators, physicians, and insurance companies.
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Neither the TSX Exchange nor itsRegulation Services Provider (as that term is defined in the policiesof the TSX Exchange) accepts responsibility for the adequacy oraccuracy of this release.
Forward-looking statements
Some statements in this release may containforward-looking information. All statements, other than of historicalfact, that address activities, events or developments that the Companybelieves, expects or anticipates will or may occur in the future(including, without limitation, statements regarding potentialacquisitions and financings) are forward-looking statements.Forward-looking statements are generally identifiable by use of thewords “may”, “will”, “should”, “continue”,“expect”, “anticipate”, “estimate”, “believe”,“intend”, “plan” or “project” or the negative of thesewords or other variations on these words or comparable terminology.Forward-looking statements are subject to a number of risks anduncertainties, many of which are beyond the Company's ability tocontrol or predict, that may cause the actual results of the Companyto differ materially from those discussed in the forward-lookingstatements. Forward-looking statements in this news release include,among other things, statements about: the anticipated filing of theaudited annual financial statements and the approval of the managementcease trade order by the Ontario Securities Commission. Factors thatcould cause actual results or events to differ materially from currentexpectations include, among other things, without limitation, theinability of the Company to obtain sufficient financing to execute theCompany's business plan, competition, regulation and anticipated andunanticipated costs and delays, the success of the Company's researchand development strategies, including the success of this product orany other product, the applicability of the discoveries made therein,the successful and timely completion and uncertainties related to theregulatory process, the timing of clinical trials, the timing andoutcomes of regulatory or intellectual property decisions, the riskthat the anticipated benefits from the receipt of funds from theInvestor will not be realized as contemplated, or at all, and otherrisks disclosed in the Company's public disclosure record on file withthe relevant securities regulatory authorities. Although the Companyhas attempted to identify important factors that could cause actualresults or events to differ materially from those described inforward-looking statements, there may be other factors that causeresults 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 madeas of the date of this news release and the Company does not undertakean obligation to publicly update suchforward-looking statements to reflect new information, subsequentevents or otherwise unless required by applicable securitieslegislation.
For further information, pleasecontact Tetra Bio-Pharma Inc.:
Ms. Natalie Leroux
Phone: + 1 (833) 977-7575
investors@tetrabiopharma.com
media@tetrabiopharma.com
SOURCE Tetra Bio-Pharma Inc.
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