- Second Clarifax received from Health Canada.
MONTREAL, Dec. 22,
2022 /PRNewswire/ - Tetra Bio-Pharma Inc. ("Tetra" or
the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1) a leader in
cannabinoid-derived drug discovery and development is providing its
shareholders with another regulatory update on the REDUVO™ New Drug
Submission (NDS). The last update was provided on November 18, 2022.
On December 21, 2022, the Company
received a second Clarification Request (Clarifax) from Health
Canada regarding the product's Risk Management Plan, which is not
atypical for a controlled substance drug. The Company will be
submitting the response to Health Canada within the allowed
timeframe. The Company cannot comment on Health Canada's response
timelines. Questions/feedback from Health Canada are received as
the review of the dossier progresses through different review
streams.
About
REDUVO™
REDUVO™ is a soft gel capsule used to treat chemotherapy-induced
nausea and vomiting (CINV). It is also used to treat weight loss
and severe nausea in people living with HIV infection. The active
pharmaceutical ingredient in REDUVO™ is dronabinol, also known as
THC, a synthetic form of the active natural substance in cannabis.
REDUVO™ 5-year cumulative gross sales expected to reach
$121M.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) is a
leader in cannabinoid-derived drug discovery and development with a
FDA and a Health Canada cleared clinical program aimed at bringing
novel prescription drugs and treatments to patients and their
healthcare providers. Their evidence-based scientific approach has
enabled them to develop a pipeline of cannabinoid-based drug
products for a range of medical conditions, including pain,
inflammation, and oncology. With patients at the core of what they
do, Tetra Bio-Pharma is focused on providing rigorous scientific
validation and safety data required for inclusion into the existing
biopharma industry by regulators, physicians and insurance
companies.
Neither the TSX Exchange nor its Regulation Services Provider
(as that term is defined in the policies of the TSX Exchange)
accepts responsibility for the adequacy or accuracy of this
release.
Forward-looking statements
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 to obtain sufficient financing to execute the Company's
business plan; competition; regulation and anticipated and
unanticipated costs and delays, the success of the Company's
research and development strategies, including the success of this
product or any other product, the applicability of the
discoveries made therein, the successful and timely completion and
uncertainties related to the regulatory process, the timing of
clinical trials, the timing and outcomes of regulatory or
intellectual property decisions 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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/reduvo-marketing-approval-on-the-right-path-301709009.html
SOURCE Tetra Bio-Pharma Inc.