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Revive Therapeutics (RVV.C) to have 10 clinical COVID-19 FDA trial sites by end of year

10/26/2020

Earlier this year, when Revive Therapeutics (RVV.C) announced they had some pharma IP that may be relevant to the treatment of COVID-19, plenty of folks laughed uproariously at the thought that a three time loser might be relevant in 2020. Having missed on an earlier pharma focus, and come to the cannabis party a little late, and joined the mushroom movement pre-coronavirus, the scoffing was so loud and long that some deep conversations were necessary before we got on board.

What tipped the balance for us was, Revive CEO Michael Frank pointing out that his company had always had a singular focus – pharmaceutical advances – all that had changed over the years were the platforms it was using to pursue that goal.

So when Frank announced one of his pieces of IP, Bucillamine, might potentially be useful to patients dealing with COVID-19, the onus was on him to prove first that others might agree, and second that he and his team had the knowledge to haul it through clinical trials.

Today, Revive announced it would have ten FDA Phase III clinical trial sites by December of this year.

Revive Therapeutics Ltd. has provided an update on its United States Food and Drug Administration phase 3 clinical trial to evaluate the safety and efficacy of bucillamine in patients with mild-moderate COVID-19. The Company has committed to ten clinical sites across Florida, Texas, Nevada, Arizona and California, and it is estimated that over 200 patients will have completed the Study for the interim analysis by the end of December 2020. The interim analysis will determine the better performing Bucillamine dose arm for the remainder of the trial and future complementary studies evaluating it in more severe cases, thus making Bucillamine a potential treatment option.

Let’s be clear, getting to this point involved proper engagement with regulators, understanding the processes involved in getting to Phase III approval, and having the ability to raise partners along the way who share the vision, not to mention convincing the FDA that Bucillamine use had real potential. None of this is easy work. If it were mere ‘me too’ hype, the company wouldn’t be where it is. There’s some ‘there’ there.

But the company does face pressures, not the least of which is folks cashing in profits after a sustained upward run. When it comes to pharma trials, a lot of investors tap out before the big day, preferring to cash in their chits rather than let the profits ride for another roll of the dice. I’m among those people – yes, I might miss out on the fat returns on the day of a positive announcement, but I’ve been riding RVV since it was 7c, so trimming a little at a 300% win is, in my opinion, fair.

There are plenty who’ll buy what I laid down, as is evidenced by an uptick in trading volume over the last week, and the news that ten clinical sites were locked and loaded is good news – but it’s not ‘new’ news exactly, what with the company a little limited in what it can say during the trial period.

With an election nearing its conclusion, the virus ramping up across the world, and RVV still in there swinging as every level of North American government prioritizes a treatment for COVID over just about any other form of business, there’s a lot to like about where Revive is moving towards, but short term investors may be churning out while the markets are wobbly.

If you’re a short term investor, biotech and pharma plays are rarely going to be for you. To get to that mega-bagger level, a smallcap has to endure a lot that’s outside its control, such as bureaucracies moving slowly, testing being unpredictable, and sometimes admin stumbles dragging the process out for months and years.

If you’re into it long term, you’ll be impressed by how far the company has moved in a short time, and contrary to early assumptions by the market. RVV has, to its credit, moved ultra quickly through the early phases of their clinical trials, has seemingly attracted bureaucratic support in getting there quickly, has money in the bank, has trials underway, and has a backup plan underway in its nascent moves in the shroom sector – you know, just in case.

The shroom sector, in and of itself, has been a-booming of late, and gives RVV a nice bit of insurance cover if COVID trials drag on.

Here’s RVV sitting above several psychedelic mover-shakers:

And here’s where it sits in relation to other COVID plays:

Bottom line, by all means trim your sails, but keep them pointed at the breeze.

 

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