Cytodyn Inc (CYDY)

[Scooter McCabe]

CYDY Road Map

This is to give everyone an idea of what could be happening, and what might happen with the shares of Cytodyn. Management, and whether HIV or COVID will get approved first.

What The Conference Will Look Like


A. The EUA was not accepted because Remdesivir and plasma a considered enough to fill the "need." As many of you are aware the leading science on plasma doubts it's efficacy, prior to it's sudden EUA the FDA put out a hold on it's use for a lack of results.

Source: https://www.fiercebiotech.com/biotech/fda-halts-covid-blood-plasma-emergency-approval

While the company navigated the science and market risk correctly. It was subject to uncontrollable political risk. It has already been noted that the FDA received pressure from the top down to approve an EUA.

Sources: https://www.statnews.com/2020/08/23/fda-under-pressure-from-trump-expected-to-authorize-blood-plasma-as-covid-19-treatment/

https://www.cnbc.com/2020/08/24/scientists-doubt-convalescent-plasma-touted-by-trump-is-a-breakthrough-coronavirus-treatment.html

If such pressure occurred the chance of approval is next to nil based on political influence. This is not within the company's ability to control. While you may wonder why the science is good but ignored, it becomes clear that you can't assign rational actions to irrational actors.

The trials will continue on into P3. The severe results however can be another knock on the door at an EUA. The lack of severe case treatments would allow the FDA come back and approve for moderate and severe without taking political flak from on high. Again political risk is a factor here. Should certain irrational actors come up with the opinion that Vitamans, Tylenol and Orange Juice were the way to go, the FDA could potentially bend if political influence was brought to bare again.

Again we would have navigated the science and market risks fine. Though the chances of not getting approved become much less as severe results would come at a critical time in the year. Winter is coming to borrow from a TV show, and political interests will have shifted to the campaign trails.

B. Nader has received notice the FDA is considering approval and will notify us after the submission of severe results or P3 interim analysis/the FDA is simply just considering.

Again much of the anaylsis from point A stands. The FDA has to wait for the news cycle on plasma to run it's course. It has to wait for political interests to move elsewhere before tossing out the news. In this case we could be weeks away from an approval.

My Take: Nader would have dropped a rejection notice on us Friday at 4pm. It gives him 2 free days of not having the market opening. He has played the news cycle in the past. He opted for Monday because the RTF for the HIV BLA revealed silver linings. A midweek drop makes no sense because it's two days for CYDY shares to get hammered.

Sources: https://seekingalpha.com/news/3590460-fda-rejects-cytodyns-leronlimab-application-for-hiv

https://www.cytodyn.com/investors/news-events/press-releases/detail/449/update-on-hiv-bla-pdufa-fda-requested-more-information-to

Approval In The UK Likely

The UK and EU have famously diverged with the FDA in the past on several drugs. One great example is how Tylenol with Codine is treated. The UK and EU treat it as over the counter buy it if you want it drug. The FDA won't permit it without a prescription.

Given the UK and EU responses to COVID, applying rational actions to rational actors makes sense. There has not been evidence of interference or pressure on health agencies. The interest is pursuing good science has remained the focus.

In the event of approvals the FDA may face pressure as current available treatments do not return the same results. UK approval is likely due to NEWS2 standard for approval. An EU approval would be huge because it applies to all EU members, so those markets open wide up.

My Take: Expect a UK approval sooner than later. If Nader has not approached EU as well already he should be removed for gross incompetence.

HIV: The reason most of us originally invested.

We have the FDA saying we should respond in writing. If Nader drops the self injecting device from the BLA and just makes people find their own syringes, opting to sell the vials instead, approval would happen overnight.

The FDA has already stated what is at issue. The 700mg data would already be in at this point. The only issue is the syringes for the self injecting device.

My Take: If Nader hasn't opted to just sell vials, or hasn't fixed the issue he should be removed for incompetence.

NASDAQ Uplist

Well we have stayed above 3 dollars since we applied. The value of landing on the NASDAQ means out of the OTC market and exposure to institutional investors and those that only trade on the exchanges. So likely we have a few issues that require clarification, but nothing that appears to say outright no at this point.

If we find out we are still waiting on the final yes or no on the EUA, or some other approval is happening we would end up on the exchange.

There really isn't anything to prevent us at this point. We have two ways in 4 dollars or 3 dollars.

My Take I give us 60/40 odds on uplisting which is my conservative guess.

Everything else is just fluff. As for Nader shotgunning news in the past. Well he did it when we had really good info, and when we got the RTF. So have fun with that.

If the only issue is the EUA for COVID, as explained earlier that is something outside of Nader's control. Everything else like responding to the BLA and actually applying to the EU are and his feet should be held to the fire over that.