Tetra Biopharma Confirms Type B Meeting Date With FDA Regarding HCC011
06 April 2020 - 2:00PM
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V:TBP)
(OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and
development, is pleased to announce that the U.S. Food &
Drug Administration ("FDA") has granted the Company’s request
for a Type B meeting related to its proposed clinical program and
overall premarketing requirements for the Company’s product HCC011
with Orphan Drug Designation. This meeting has been scheduled
for May 29, 2020.
HCC011 is an inhaled
delta-9-tetrahydrocannabinol (THC) formulation to be developed as
an adjunct treatment to first-line therapy to improve disease
control in inoperable, advanced hepatocellular carcinoma patients.
In addition to its anti-emetic effect and its capacity to enhance
patient health-related quality of life, HCC011 should also have
anti-tumor effects, improving patient outcome and prognosis in
their battle against liver cancer.
According to Dr. Guy Chamberland, CEO and Chief
Regulatory Officer of Tetra, "in December 2019 news release, we
revealed our intention to submit the request for a Type B meeting
with the FDA. Earlier this year, our regulatory and clinical
team prepared the submission and last week we received confirmation
that the meeting with FDA had been granted. On May 29, the
FDA will be providing guidance on our planned phase 2 clinical
trial, expedited review paths, and 505(b)(2) premarketing
requirements. Tetra also plans to provide the FDA with data
from our ongoing metabolite study".
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V:TBP) (OTCQB:TBPMF) is a
biopharmaceutical leader in cannabinoid-based drug discovery and
development with a Health Canada approved, and FDA reviewed and
approved, clinical program aimed at bringing novel prescription
drugs and treatments to patients and their healthcare providers.
The Company has several subsidiaries engaged in the development of
an advanced and growing pipeline of Bio Pharmaceuticals, Natural
Health and Veterinary Products containing cannabis and other
medicinal plant-based elements. With patients at the core of what
we do, Tetra Bio-Pharma is focused on providing rigorous scientific
validation and safety data required for inclusion into the existing
bio pharma industry by regulators, physicians and insurance
companies. Could we work in “existing regulatory standards of
safety and clinical evidence for pharmaceutical products”.
For more information
visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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the adequacy or accuracy of this release.
Forward-looking statementsSome
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
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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.
For further information, please contact
Tetra Bio-Pharma Inc.:
Investor Contact:Pascal NigenAlpha Bronze,
LLCMr. Pascal NigenPhone : + 1 (646)
255-0433tetra@alphabronze.net
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