The Dr. Jay Lalezari interview that was recently posted on the board was excellent. Such a compassionate and honorable man, I have great respect for his integrity.
If you do nothing else, you owe it to yourself (and your investment) to listen to this 5-minute excerpt from that 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”
My 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 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 way he runs the business.
- It is now clear why the FDA released that damaging letter a couple of days ago, and why they did it during market hours – they did it to publicly spank Nader
- 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.
Dr. Jay Lalezari is one of the most honest and sincere men I have ever come across. I implicitly trust what has has said in this interview.
At the same time, I have great respect for what Nader has accomplished, and I recognize that we wouldn’t be here without him.
However, the millions of sick and dying patients that can be helped by leronlimab deserve better -- and we as investors deserve better.
Nader’s said it himself yesterday – if he is doing a bad job – he needs to leave.
Nader's terminally damaged relationship with the FDA has effectively 'shelved' leronlimab and I see no forward progress while he 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
If you do nothing else, you owe it to yourself (and your investment) to listen to this 5-minute excerpt from that 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”
My 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 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 way he runs the business.
- It is now clear why the FDA released that damaging letter a couple of days ago, and why they did it during market hours – they did it to publicly spank Nader
- 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.
Dr. Jay Lalezari is one of the most honest and sincere men I have ever come across. I implicitly trust what has has said in this interview.
At the same time, I have great respect for what Nader has accomplished, and I recognize that we wouldn’t be here without him.
However, the millions of sick and dying patients that can be helped by leronlimab deserve better -- and we as investors deserve better.
Nader’s said it himself yesterday – if he is doing a bad job – he needs to leave.
Nader's terminally damaged relationship with the FDA has effectively 'shelved' leronlimab and I see no forward progress while he 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
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