RE:There was some very good news last week. CZO mgmt must have learned a thing or two on how to pump from others....
Tetra expects $675M (U.S.) in QIXLEEF net sales by 2027
2020-12-07 08:46 ET - News Release
Dr. Guy Chamberland reports
TETRA ESTIMATES NET SALES REACHING $675M USD BY 2027 TETRA IS EVALUATING POTENTIAL COMMERCIAL PARTNERS TO LAUNCH QIXLEEF IN USA
Tetra Bio-Pharma Inc. has provided an update on the potential U.S. market for QIXLEEF, a botanical cannabinoid-derived medicine that meets U.S. current good manufacturing practice regulatory requirements. This botanical drug product composition has a fixed ratio of THC (tetrahydrocannabinol) and CBD (cannabidiol). The product is inhaled through a medical device (vaporizer) and will be first indicated in advanced cancer patients with inadequately controlled pain.
Based on a conservative market penetration and patient-based model, Tetra estimates potential net sales of $675-million (U.S.) by 2027. Tetra is in the process of evaluating a potential strategic partner to run its commercial execution in the United States. It is still premature to provide details on royalty level, upfront and milestone payments.
Leading up to an expected market approval from the FDA in 2023 will be completion of the phase II trial in 2021, phase III trial in early 2022 and new drug application (NDA) submitted in 2022. Market approval typically follows nine to 10 months following NDA submission.
The patient-based model assumes that Tetra will secure a market approval from the FDA for its Qixleef in advanced cancer patient with inadequately controlled pain with a launch late 2023. Tetra also assumes that the Qixleef kit (Qixleef and its accompanying medical vaporizer) will be reimbursed by health maintenance organizations (HMO). The company's forecast also reflects the second planned indication in breakthrough pain which should follow soon after its first new drug application (NDA) through a supplemental marketing approval application (supplement to new drug application; sNDA). Its forecast remains conservative as it does not reflect potential opioid sparing usage.
Finally, Qixleef safety have been established through traditional dose escalation phase I trials and an in-depth study of the composition of inhaled volatile organic compounds. In addition, the NDA will be supported with data on the metabolite profile, pharmacokinetics, pharmacodynamics and exposure to neutral and acidic forms of phytocannabinoids. Tetra is currently running a phase II trial in the U.S. called Plenitude and preparing the European phase III trial.
Dania Scott, senior vice-president, commercial strategy, commented: "Tetra is leading the way with inhalation cannabinoid therapy in an ever-evolving therapeutic space. There are no precedents to follow in the pharmaceutical industry. Qixleef proprietary safety and dosing data and fast-acting effect can alleviate crippling pain for patients in need of immediate relief. Tetra believes that Qixleef has the potential to enable patients to significantly reduce their use and dependence on opioids. Qixleef therapeutic potentials and its addition to physicians' armamentarium will help evolve the quality of life for patients and their caregivers."
About Tetra Bio-Pharma Inc.
Tetra Bio-Pharma is a biopharmaceutical leader in cannabinoid-based drug discovery and development with an FDA- and a Health Canada-approved clinical program aimed at bringing novel prescription drugs and treatments to patients and their health care providers. The company's evidence-based scientific approach has enabled it 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 it does, 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.
We seek Safe Harbor.
captwade wrote: It was easy to miss though because it only lasted about 20 seconds.
For some years now we have listened to some of the most boring of presentations from this company. We hear words like exciting, potential, helluva fantastic, masterpiece, and a new one last week, gem. None of these words mean anything to a serious investor. We were made aware of the huge markets that we eventually may get a piece of but were never given a clue as to what that could, in the end, mean for CZO.
Last Wednesday we saw a small move in the right direction when Gagnon spoke, albeit briefly, about the net present value of a discounted future cash flow that a 3% share of the YBG market would mean to CZO. He threw out a figure of $100,000,000. or about $1.30 per share. I think this is what appears to have excited the market for our shares because the inferrence is that the current fair market value of CZO shares would be something over $2.00 { $1.30 plus the $.79 we are trading at. I repeat, fair market value TODAY.
Cheers all.