I think one of us doesnt fully understand the process to obtain FDA approval for a drug. I'm talking final approval like the one GWPH got for their anti epileptic seizure medicine Epidiolex.
A company must demonstrate to the FDA that the drug is effective and safe (there can be some negative side effects but they must be well documented and the damage from side effects vs damage from untreated disease is factored in, etc). The only way to prove effectiveness is the double blind clinical trials, 3 of them. These trials are super expensive so CVSI would need to sell shares and/or take on debt to get the funding.
They are a very long, timely (year +), and expensive way from getting any approval to sell this drug. As they show on their site they have yet to do the 3 clinical trials:
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