From another board Thanks to “Thoughtful inve
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Posted On: 09/17/2020 12:16:17 PM
From another board
Thanks to “Thoughtful investing” on finance yahoo board for posting this.
Here are my top line takeaways for longs from yesterday's Cytodyn conference call:
1. The well respected independent clinical research doctors who administered leronlimab to their patients in emergency situation and in placebo controlled Covid 19 trials were impressed enough with the results to make the effort to submit research papers to peer reviewed publications about the startling results.
2. The Phase 2 mild/moderate symptom patients CD010 study's statistically significant NEWS2 results, clinically significant symptom results and amazing and unprecedented safety results vs placebo are being taken seriously by the FDA and UK regulatory authorities. In fact, FDA is working with Cytodyn to design a Phase 3 study (the normal progression from Phase 2) for the moderate patients which the company believes will show even more dramatic results. This makes sense because moderate symptom patients are sicker than the mild symptom patients so improvements will be more dramatic and easier to suss out statistically.
3. Neither FDA nor UK is willing to exercise its emergency use procedure to allow marketing to the Covid mild/moderate patient population which is overwhelmingly likely to get better on their own. Not an unreasonable risk/benefit calculation. But they are very willing to exercise this authority for the severe/critical population and are anxious to see the interim results of the 195 patients in the CD012 trial. If the results show statistical significance in improving outcomes, they are ready to exercise their emergency use authority. We will have these interim results first two weeks of October and emergency approval could follow any time after that and is therefore obtainable by the end of 2020.
4. Once an emergency approval is obtained, doctors will be able to prescribe leronlimab for moderate Covid 19 patients using their "off label use" discretion.
5. The Phase 3 HIV 700 mg mono therapy trial successfully met the study endpoints and, based on the Sept 8 meeting with FDA, the company believes it has all the information necessary to fill in the holes in the HIV BLA for HIV mono therapy. They will be submitting it for completeness review asap. FDA will review it for completeness within 30 days and if complete, the PADUFA review completion date will be set.
6. There is strong animal study evidence that leronlmab penetrates the blood/brain barrier making it a promising candidate to treat brain diseases like Alzheimers, MS and other diseases.
7. The Phase 2 Nash trial will start enrolling in early October. This is an unmet medical need with a potential $20 billion market. Triple negative breast cancer trial continues with fast track status. The other cancer studies for the 22 solid tumors is proceeding.
In sum, the drug works, it will be approved for Covid or HIV and most likely in the next 3 to 10 months and has tremendous upside potential for other diseases. In light of this, the current $4.03 share price is ridiculously cheap.
If you don't believe the above or don't have the patience to weather the vicissitudes of the regulatory process, you should sell your stock. I am not selling any of mine.
One other point that I have mentioned before affecting the share price. There is about a 27 million share short interest in CYDY. These are shares that have been borrowed and sold or are a naked short. Given the low 3-4 million average volume lately, if the CYDY price rises significantly, they will will be forced to cover and this will drive the price significantly higher. These shorts will be caught in a short squeeze. So you can expect them to do everything in their power, including dishonest hit pieces like we have seen from Citron and AF and massive short attacks, to prevent the share price from rising significantly. This has nothing to do with the scientifically supported promise of leronlimab. If you are long, you should ignore it.
Thanks to “Thoughtful investing” on finance yahoo board for posting this.
Here are my top line takeaways for longs from yesterday's Cytodyn conference call:
1. The well respected independent clinical research doctors who administered leronlimab to their patients in emergency situation and in placebo controlled Covid 19 trials were impressed enough with the results to make the effort to submit research papers to peer reviewed publications about the startling results.
2. The Phase 2 mild/moderate symptom patients CD010 study's statistically significant NEWS2 results, clinically significant symptom results and amazing and unprecedented safety results vs placebo are being taken seriously by the FDA and UK regulatory authorities. In fact, FDA is working with Cytodyn to design a Phase 3 study (the normal progression from Phase 2) for the moderate patients which the company believes will show even more dramatic results. This makes sense because moderate symptom patients are sicker than the mild symptom patients so improvements will be more dramatic and easier to suss out statistically.
3. Neither FDA nor UK is willing to exercise its emergency use procedure to allow marketing to the Covid mild/moderate patient population which is overwhelmingly likely to get better on their own. Not an unreasonable risk/benefit calculation. But they are very willing to exercise this authority for the severe/critical population and are anxious to see the interim results of the 195 patients in the CD012 trial. If the results show statistical significance in improving outcomes, they are ready to exercise their emergency use authority. We will have these interim results first two weeks of October and emergency approval could follow any time after that and is therefore obtainable by the end of 2020.
4. Once an emergency approval is obtained, doctors will be able to prescribe leronlimab for moderate Covid 19 patients using their "off label use" discretion.
5. The Phase 3 HIV 700 mg mono therapy trial successfully met the study endpoints and, based on the Sept 8 meeting with FDA, the company believes it has all the information necessary to fill in the holes in the HIV BLA for HIV mono therapy. They will be submitting it for completeness review asap. FDA will review it for completeness within 30 days and if complete, the PADUFA review completion date will be set.
6. There is strong animal study evidence that leronlmab penetrates the blood/brain barrier making it a promising candidate to treat brain diseases like Alzheimers, MS and other diseases.
7. The Phase 2 Nash trial will start enrolling in early October. This is an unmet medical need with a potential $20 billion market. Triple negative breast cancer trial continues with fast track status. The other cancer studies for the 22 solid tumors is proceeding.
In sum, the drug works, it will be approved for Covid or HIV and most likely in the next 3 to 10 months and has tremendous upside potential for other diseases. In light of this, the current $4.03 share price is ridiculously cheap.
If you don't believe the above or don't have the patience to weather the vicissitudes of the regulatory process, you should sell your stock. I am not selling any of mine.
One other point that I have mentioned before affecting the share price. There is about a 27 million share short interest in CYDY. These are shares that have been borrowed and sold or are a naked short. Given the low 3-4 million average volume lately, if the CYDY price rises significantly, they will will be forced to cover and this will drive the price significantly higher. These shorts will be caught in a short squeeze. So you can expect them to do everything in their power, including dishonest hit pieces like we have seen from Citron and AF and massive short attacks, to prevent the share price from rising significantly. This has nothing to do with the scientifically supported promise of leronlimab. If you are long, you should ignore it.
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