Tetra Bio Pharma (TSXV: TBP) announced further details surrounding its FDA clinical traisl of Qixleef this morning, including the expansion of the global market for the product to include noncancer pain indications.
Following the previously announced Type B meeting conducted between Tetra and the US Food and Drug Administration (FDA), additional details on the clinical development program to be conducted by the company have been released. The firm will first conduct the trials utilizing Plentitude. A successful program on this will enable Tetra to commercialize “the world’s first dried flower botanical cannabinoid drug product for the treatment of pain in patients with an advanced refractory cancer.”
The FDA has also validated the program proposed by that of Tetra, while also providing areas on which they could provide a waiver to certain processes. Those waivers are anticipated to save Tetra up to $5 million for the first marketing application of Qixleef. As the program advances, Tetra will also expand it to target patients with non-cancer pain, which it would then seek approval for to expand the global market that Qixleef can be used within.
This potential expansion to the larger pain market rather than that of just advanced refractory cancer enables Tetra to potentially compete in the global $44.3 billion first line therapy and self care segment, rather than the previously intended $2.2 billion market for specialized cancer pain treatments.
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.
Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra
Full details on Tetra’s FDA clinical development program can be sourced via this mornings news release here.
Tetra Bio Pharma last traded at $0.39 on the TSX Venture.
Information for this briefing was found via Sedar and Tetra Bio-Pharma Inc. The author has no securities or affiliations related to this organization. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security. The author holds no licenses.
