RE:RE:RE:my last two cents on this boardStinzo wrote: yet no one beleives in it, not even the people involved...
In biotech there is a very important step called validation. It is very hard for you or me or the market in general to know all that is necessary about a product having never tested it in person or never having been in the facility and had engineers investigate the plant and any issues concerning scale-up, etc. Have you ever tasted the drink for instance? Have you personally tested the product's stability? Have you ever been in the plant and witnessed a production run? Reading news releases can only provide so much information and the company may not even want all details released for competitive reasons at an early stage for fear of being targeted. What if a credible life sciences company comes in, however, and signs a major deal after inspecting the facility and testing the product and commits to large scale-up, and trials, etc? We would have credible validation. What if the current scale-up is a success and a licensing deal is entered validating commercial-scale production for the first time and that PGX can now be sold on the market and generate revenue? Right now CZO only has a pilot plant and theoretically it could be years before commercial-scale production is achieved, if ever. The five-fold scale-up CZO is now working on, if successful, would also be that much closer to truly mass-scale production decreasing risk. Completing the current scale-up and licensing a commercial-scale product is a major inflection point and proof point for the technology. Often the pay-off for investors after a very long wait comes with commercial-scale validation by way of licensing agreement. The pay-off for investors can often happen in a single day after a halt to trading and it can be difficult to time. You have to be in before the crowd.
As for the aveanthramide pill a Phase I/IIa clinical trial has now been approved by Health Canada. Product development risk and regulatory risk to get here are now behind the company. Clinical trials generally have a predictable timeline from here as clinical trial participants are enrolled, administered the drug, and as the data is collected. In about 18 months CZO may have a safety/tolerability profile for the product in humans as well as hints of efficacy in patients suffering from mild inflammation. Human safety/tolerability and efficacy data in patients is obviously critical. CZO has indicated it will then sign a licensing deal. This deal would provide key validation; including with a human safety/tolerability efficacy profile for the drug for a large market. The Principal Investigator for the clinical trial, from the influencial Montreal Heart Institute, is also influencial in the field of inflammation and heart disease.
The fibrosis drug is expected to reach a 'go', 'no go' decision in the second half of the year for human trials. Just as with avenanthramide CZO may be leaving the lab and mice for human testing. The team at McMaster is well known in the industry and supported Avalyn Pharma's inhaled drug. Dr. Kjetil Ask is now with the second largest pharma in the world and one of its leading researchers. He has also published with scientists from Boehringer Ingleheim which owns one of the two major IPF drugs currently on the market. The team working with CZO has clout. Human trials may soon be here.
If you are a conspiracy theorist and believe that the Canadian Government has continued to invest in CZO to dupe shareholders or out of incompetence, and that CZO has continued to invest its profits in these programs when it could have done otherwise for the same reasons, and that people with reputations like Dr. Ask, Dr. Kolb, Dr. Hoare, Dr. Li, as well as Ronnie Miller are just out to milk sharholders and that they don't believe in the words they've spoken that's your choice and time will tell. Someone like Ronnie Miller with his 22 years as the President and CEO of Roche Canada could surely find an important and valuable place to put his time. As for Gilles, he has dedicated the most important years of his professional career to CZO after working with major companies Novartis and Sandoz. He hasn't sold a single share of CZO during his decade with the company and has only added shares over time. A considerable amount of his personal fortune is likely tied to CZO's shares. He's built the base business to ~$20 mllion in revenue with leading brands in the industry and $20 billion market cap Symrise. He's attracted people of high reputation to help develop the pipeline from Dr. Ask, to Dr. Hoare, to Dr. Kolb, to Dr. Tardif. He's received substantial development funding from the Canadian government along the way after its experts have provided input.
Commercial-scale production; commercial-scale validation; human clinical trials as opposed to testing in mice; safety/tolerability and efficacy data in human and a potential licensing deal. Biotech can take a decade to develop. The payoffs are often within a few days of key events. The key events for this company are approaching, in my opinion. People will be in before the crowd or they won't. We all have to make our own minds up if the risk from here is worth it or not.