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Re: baldingcontrarian post# 54031

Thursday, 08/08/2019 4:03:40 PM

Thursday, August 08, 2019 4:03:40 PM

Post# of 83039
An "illegal product." Well, that's a matter of debate. You make it sound so simple (maybe we need a hat, "this CBD stuff is easy peasy." CVSI has been selling an illegal product for the past 4 plus years (and that was before the Hemp Act - you could argue it was doubly illegal). With the Hemp Act, it only became partly illegal, and that's mainly because FDA says it is illegal to put into dietary supplements (now that GW Pharma is approved with high dose CBD). However, FDA's job in the supplement arena (per DSHEA and updated act in 2007), is to remove unsafe products from the market. What is unsafe? Well, clearly if it's hurting users (i.e., FDA hears about adverse events in users); if it's adulterated (say you put an approved drug like Cialis in your supplement) or if you mislabel it ("effective for arthritis, cancer, etc.). FDA has acted to remove mislabeled CBD products as recently as last month with Curaleaf (but other times before then). This has never happened to CVSI because WE DON'T MISLABEL. However, now that we have a published study, we can actually make disease claims (e.g., effective for improved sleep, stress) because we have a published study. So FDA has "allowed" CVSI to sell "illegal" products for > 4 years. Why? Because they are not unsafe!!

Add to the recent conversation about CVSI filing an NDI (New Dietary Ingredient) application with FDA (which I suspect they will do). Add to that the self-affirmed GRAS (and I bet they will submit that data so that we can get FDA GRAS certification).

Add to that a clinical development program for an unmet medical need (smokeless tobacco), which will NOT cost that much money to get to Phase I. There is no way that CVSI goes beyond Phase I. So they are finishing up the IND, in which they will propose a Phase I study of probably 30-40 patients. It will probably last 28 days, and if successful, they will partner with someone. This can be huge, even bigger than the commercial side.

So as frustrating as the past 2 days have been, we have so much positive stuff in the pipeline. Do not know why some investment firms don't grow some gonadal tissue and buy 100K shares or more. "Too risky." Really. Grow some.

All the best.

MT

PS Will poster STOP referring to our peak of 9.2. I know that Yahoo considers it our 52 week high, but it's BS. It was a 30 minute run-up by Left to send it slamming down to 3.5. IMO, we were tracking at 6 that day before the artificial run up and unceremonial drop down.