- Tetra Bio-Pharma Confirms Meeting with the FDA to Align on the
Requirements for Marketing Authorization
OTTAWA, ON, Nov. 29, 2021 /PRNewswire/ - Tetra Bio-Pharma
Inc. ("Tetra" or the "Company") (TSX: TBP)
(OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug
discovery and development today announced that it received a letter
from the United States Food and Drug Administration (FDA), granting
a Type C meeting to discuss safety and labelling requirements for
obtaining marketing approval under the 505(b)(1) regulatory pathway
for its QIXLEEF™.
QIXLEEF™ is a botanical inhaled investigational new drug with a
fixed ratio of THC and CBD that meets USA cGMP regulatory requirements. The
delivered-dose uniformity (DDU) of the aerosol generated by the
Mighty Medic® medical device meets the criteria established by FDA
for inhalation aerosols (also known as metered dose inhalers (or
MDIs)) and inhalation powders (also known as dry powder inhalers
(or DPIs)). The DDU is a measure of the drug discharged from the
mouthpiece of an inhalation device and compares that measurement to
the target delivered dose. Meeting the DDU specification is
critical for a quality inhaled drug product.
Earlier this year, Tetra announced it received from the Malta
Medicines Authority (MAA) a Scientific Advice Assessment (SAA)
Report. The Report provided positive feedback on Tetra's drug
development plan for QIXLEEF™ and eligibility for submitting a
Marketing Authorization Application (MAA) under Directive
2001/83/EC (Directive). The SAA Report endorsed Tetra's proposed
plan to address the nonclinical safety requirements for submitting
a marketing approval application for QIXLEEF™.
These safety studies are both time consuming and very costly and
can impact the timing of the submission of a marketing application.
Dr. Guy Chamberland, Chief Executive
Officer (CEO) and Chief Regulatory Officer (CRO) of Tetra
Bio-Pharma said "the MAA's response confirmed that our
nonclinical safety strategy is acceptable and would satisfy the
requirements of article 8 of the Directive. Now we need to
obtain the FDA's final guidance on this strategy to ensure QIXLEEF™
makes it to the market at the lowest cost."
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.
For more information visit: www.tetrabiopharma.com
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.
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SOURCE Tetra Bio-Pharma Inc.