Tetra Bio-Pharma Accelerates its European Drug Registration Activities
September 11 2018 - 7:00AM
Tetra Bio-Pharma Inc. ("
Tetra" or
the "
Corporation") (TSX VENTURE: TBP) (OTCQB:
TBPMF), a global leader in cannabinoid-based drug development and
discovery, announced today that it is accelerating the submission
of a pre-marketing application for the registration of its cannabis
drugs PPP001 and PPP005 under Directive 2001/83/EC of the European
Parliament and of the Council.
This directive provides Tetra Bio-Pharma with
the legal and regulatory framework needed to submit its
pre-marketing application for its cannabis drugs. According
to Dr. Guy Chamberland, Interim CEO and CSO, “the corporation has
performed its own clinical trials and has sufficient quality and
clinical trial data to initiate the application for the
registration of PPP001 and PPP005 under the Directive
2001/83/EC. Tetra intends to pursue a Full Market
Authorisation since it has a dossier supporting the medicinal
product’s quality, safety, and efficacy.”
All of Tetra’s clinical trials were performed
with the same quality of evidence required by the National
Competent authorities approving medicines/drugs. Tetra has
completed several well-designed safety, pharmacodynamic and
pharmacokinetic studies in healthy volunteers and also has two
ongoing, well-designed clinical trials in patients. These
trials are all double-blind, randomized and placebo
controlled.
About Tetra Bio-Pharma
Inc.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,
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.
For more information visit:
www.tetrabiopharma.com
Source: Tetra Bio-Pharma
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for 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
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 approval of
PPP001 and/or PPP005 by the European Medicines Agency, the
applicability of the discoveries made therein, the successful and
timely completion and uncertainties related to the regulatory
process including the applications for Orphan Drug Designation, 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. While no definitive documentation has yet been signed
by the parties and there is no certainty that such documentation
will be signed. 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.Robert Bechard
Executive Vice-President Corporate Development and
Licensing514-817-2514 Investors@tetrabiopharma.com
Media
Contact |
|
Energi PR |
|
Carol Levine |
Stephanie Engel |
514-288-8500 ext.
226 |
416-425-9143 ext.
209 |
Carol.levine@energipr.com |
Stephanie.engel@energipr.com |
Tetra Bio Pharma (TSXV:TBP)
Historical Stock Chart
From Apr 2024 to May 2024
Tetra Bio Pharma (TSXV:TBP)
Historical Stock Chart
From May 2023 to May 2024