Cytodyn Inc (CYDY)

[cytodyn storm]

misiu143 -- those are all excellent questions.

And while we're waiting for the answers to those excellent questions -- you must acknowledge that Nader has already made it impossible for leronlimab to be approved by the US FDA for ANY indication.


Dr. Jay Lalezari is a smart, compassionate and honorable man, and moreover -- he is an honest man.

If you do nothing else, you owe it to yourself to listen to this 5-minute excerpt from a recent interview:

http://lalezari.s3.amazonaws.com/lalezari.mp3

In 5 short minutes, we learn the following:

1. There is an unproductive relationship between the FDA and CytoDyn

2. That unproductive relationship was forged over many years during the HIV trials

3. Everything in CytoDyn’s development of the HIV indication was “ass-backwards”

4. CytoDyn has stumbled along for years, enrolled hundreds of patients, and spent untold millions of dollars

5. In the course of those years, the relationship with the FDA became unproductive

6. The way that CytoDyn does business is completely foreign to the FDA

7. The FDA frowns upon Nader’s frequent press releases, which are sometimes issued two-a-day

8. The FDA looks at that behavior as being “out of bounds” as a way of running a company

9. There is a personal history between the FDA and CytoDyn which is troublesome

10. The FDA doesn’t like the “press release way” of running the company

11. The dysfunctional relationship between the FDA and CytoDyn has gone “nowhere”


Conclusions:

- The FDA is going to continue stringing CytoDyn along, and likely has no intention of approving the Combo HIV BLA because of the damaged relationship with Nader.

- In the face of a terrible global pandemic, and with a therapy that shows great promise and “does no harm”, the FDA has likely not granted leronlimab an EUA because they do not respect or trust Nader, or the way he runs the business.

- It is now clear why the FDA released that damaging letter, and why they did it during market hours – they did it to publicly spank Nader and CytoDyn.

- Every other leronlimab indication on the roadmap, COVID, LONG COVID, HIV, CANCER, NASH, GvHD, MS, STROKE and all of the others, will likely experience an insurmountable uphill battle because of Nader’s troublesome relationship with the FDA.

- Our many conspiracy theories about Big Pharma influence being used to hurt CytoDyn are likely misplaced – it is the FDA having no respect for Nader and CytoDyn

- It is now finally clear why Nader has been so obsequious towards the FDA – he has damaged that relationship and he is desperately trying to prevent it from getting worse -- and in the process, he has destroyed leronlimab’s chances of saving lives and treating terrible diseases.

The millions of sick and dying patients that can be helped by leronlimab deserve better -- and we as investors deserve better.

Nader said it himself – if he is doing a bad job – he needs to leave.

Nader has terminally damaged CytoDyn's relationship with the FDA, and has effectively 'shelved' leronlimab. In other words, it is the equivalent of leronlimab being acquired by a Big Pharma who has a competing product -- and they simply want to put leronlimab on a shelf so it can't be used. It is a simple fact that there can be no forward progress while Nader is at the helm.

Lastly, if you want to listen to the full interview, it is available using this link:

https://savageminds.substack.com/p/jay-lalezari