Tetra Bio-Pharma (TSXV:TBP,OTCQB:TBPMF) gave investors more details on its drug development program for a candidate after it engaged with the US drug regulator.
As quoted in the press release:
The clinical development program of QIXLEEF in the USA begins with the PLENITUDEclinical trial. This FDA authorized clinical trial assesses the clinical impact of QIXLEEF in advanced cancer patients with uncontrolled pain. A successful PLENITUDE clinical program, allows 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 validated Tetra’s nonclinical program proposed to support clinical trials in non-cancer pain indications and the New Drug Application. This guidance from FDA is critical to the success of the clinical trials and the timing to commercialization because of the costs implicated with the performance of a full nonclinical program. The FDA confirmed areas where Tetra could obtain a waiver for some of the nonclinical safety requirements based on the target patient population. “Confirmation of the waivers was critical because it confirms Tetra’s understanding of the regulatory requirements. The waivers represent a short-term savings of over 5 million dollars for the first marketing application of QIXLEEF as well as further potential savings,” stated Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra.