This is quite exciting guys. I know we've had a tough run lately, and this thing is moving really slowly, but I think its important to remember that 'Rome wasn't built in a day' as they say. Granted, I too have expressed frustration with management of late, and I do think they could improve drastically in some areas (mainly communication), but positive trial results here could be really special. I think more significant than Zenivol, here's why:
1) The trial is utilising our medicinal cannabis product, dosed in pill form. I think this is a really significant factor as I'm not aware of any other medicinal cannabis companies that have a cannabis drug dosed in this form. Its important because people are accustomed to this dosage form, and it gives confidence that the amount administered to a patient is the same every time.
2) In 2018, the FDA approved Epidiolex, created by GW Pharmaceuticals. This was the first FDA approved cannabis derived drug and I believe its still the only approved non-synthetic, FDA approved cannabis drug on the market. Why did this drug obtain approval? The FDA stated that the reason was as follows "Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes." This is exactly what Zelira are currently attempting to do with respect to Neuropathic pain. But it gets more interesting...
3) With respect to Epidiolex, the FDA confirmed the following "The FDA granted Priority Review designation for this application. Fast-Track designation was granted for Dravet syndrome. Orphan Drug designation was granted for both the Dravet syndrome and Lennox-Gastaut syndrome indications". What does a drug need to do to be granted priority review and fast track designation from the FDA?
For Priority Review - the FDA states "A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications". Zelira is comparing their drug directly against one of the major treatment forms currently on the market.
Fast Track Designation - The FDA states "Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy." That last sentence is crucial. Zelira is attempting to demonstrate that their drug is significantly better (and safer) than current treatments.
So, if the trial results are successful, I think Zelira will apply for priority review and fast track designation from the FDA based on the above. That could be as early as next year. I wouldn't be surprised to see them partner with a large pharmaceutical firm to fund further trials if required given phase three is so expensive. If this application was to be successful, this would mean that Zelira is the second company ever to have a non-synthetic cannabis drug approved by the FDA.
The sky is the limit from there in terms of revenue.
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