Allow me to follow one of my favorite posters - me. It pertains to Vandy's recurrent and insipid lack of understanding of the drug development process. I've been in pharma a long time and can speak to it. Dowling stated that they expected to be ready by Q3 or Q4 of this year to make a definitive decision on how to proceed. This means that they are tracking to complete the pre-IND work (investigational new drug). That takes a lot of time and effort. Here's the thing - this is not a "me too" antibiotic or small molecule product (i.e., pill). It's a combo of nicotine and CBD. The nicotine part has been well-characterized and I suspect they'll use 2 doses of nicotine, both of which have been characterized. I suspect they'll be able to use some of the valuable info about how CBD behaves from GW Pharma's application. How much? I don't know, but they probably won't need to do a full on approach to characterize it. But here's the challenge-how does CBD interact with nicotine? Never been studied. They'll need to do that. I assume they will use 2 or 3 strengths of CBD with 2 doses of nicotine gum. They'll need to determine how the 2 behave together in animal studies. They'll need to measure both nicotine and CBD in a pharmacokinetic study, and make sure absorption and metabolism of both occur in a consistent fashion. Not easy, but do-able.
Oh yeah, and then they have to formulate the different doses of CBD with the 2 doses of gum (I assume this because some people are very addicted to tobacco (chew constantly) and some less addicted. They need to be able to show they can formulate a precise amount of CBD with the different strengths of nicotine. Not easy but do-able. Once they do that, then they can propose a phase 1 study. Normally a phase 1 study is in healthy volunteers, but I suspect they will conduct it in chewers. Why? Because in non-tobacco users, nicotine gum will have adverse events related to nicotine. Regular users will be accustomed to that.
So in Q4, I suspect they create a real clinical development plan that will call for studying 25-40 tobacco users. They'll also have a placebo group (which may be just nicotine and no CBD). This is all do-able. They will present this plan to FDA, and if they don't hear from them in 30 days, then they are free to start the study.
IMO, CVSI will conduct the Phase 1 study (not too expensive) and if they have a positive result, they will either partner with big pharma or sell off the drug, which will be valuable.
Vandy keeps asking, "where's the drug? Where's the trials? Well, most brilliant one, that takes time and serious effort. I believe they're doing that. And I'm tired of people ignorant of the process spouting off with BKK-like incorrect maxims.
If creating a drug was easy and cheap, plenty would be doing it. I trust that Dowling and Co. are going about this as quickly as possible. Since there are studies of the successful use of CBD in animal models of nicotine addiction and opiate addiction, it's a good bet that it may work in human. The trick will be the right dose. You try to extrapolate from animal models (i.e., the concentration of CBD/nicotine in animals for a given dose) and intelligently pick two doses for the trial. Not done lightly.
If they are successful, the drug will be way more valuable than even the fantastic non-pharma side, even if sales get to $25M per quarter, which Dowling mentioned he is targeting company wide.
Hang in there and investors will be rewarded. Don't be deterred by imposters, who post repetitive drivel, often peppered with factual information. Vandy doesn't make all of his stuff up, but he can't see the forest for the trees.
I have sold 5% of my holding over 3 years to pay for college tuition and taxes, and I'm waiting a good while longer. I think this stock is an easy double this year, likely higher.
Finally, did you hear Dowling say that he didn't want to give guidance because it would be rocky up. He did not suggest he was worried about bad quarters but rather he couldn't intelligently guestimate HOW HIGH we would go.
A nice problem.
All the best.
MT
AI
