Tetra Bio-Pharma Provides Additional Information on QIXLEEF Following Letter of Advice & Type B Meeting with USA FDA - Seite 2

The FDA reviewed and provided scientific validation of Tetra’s proposed approach to ensuring the quality of the botanical raw material and drug product specifications and how Tetra will ensure the comparability of the non-medicinal ingredients (i.e., volatile organic compounds) from lot-to-lot across the nonclinical and clinical programs.  Tetra must demonstrate to the FDA that the QIXLEEF batches used in clinical trials will be comparable to those of the commercial lots as well as those that were used at every stage of the drug development program. 

The FDA’s validation of the botanical raw material specifications and quality control was essential to ensure the acceptability of the data packages that would be used for the marketing application as well as ensuring a successful global market penetration.  “There is biological variability associated with the use of any botanical raw material.  Obtaining the FDA’s validation on the scientific approach used by Tetra was a significant step forward for QIXLEEF.  We are now in an excellent position to bring this new drug to the market,” stated Dr. Guy Chamberland.

The expansion of the indications will allow QIXLEEF to compete in a very competitive $44.3Bn market size¹ compared to the previous $2Bn market.  The $44.3Bn market includes all first line therapies and self care options.  Duloxetine and pregabalin, for example, at peak, were both selling $9Bn globally².

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, 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.