The share price action in the past week rattled me to the point of almost pulling out. What an emotional rollercoaster. The investor environment changed from a thoughtful one based on science to short sellers and fear. However, Cytodyn has so many irons in the fire, it’s difficult to sell due to FOMO.
These items hold my attention over the next two weeks:
1) Announcement of distribution agreement on Monday (says Nader on his own internal clock)
2) Up-Listing (by my calculation July 16th is about 6 weeks into the process)
3) Reveal of M/M clinical trial for COVID-19 (maybe after up-listing to get the most benefit, but sooner is better)
4) Wild Card. There is a potential for a licensing deal for an indication (HIV, cancer, NASH) at any time. Many CYDY investor calls have mentioned ongoing discussions. There is a tension for interested companies to wait for more data but, on the other hand, the price goes up or another company can jump in ahead. There seems to be enough promise on HIV and cancer in humans, and NASH and MS in animals that something could happen at any time. Efficacy in COVID would add to the reality of Leronlimab’s promise as a wide spectrum therapy.
My Big picture:
It appears to me that the Severe/Critical Phase 3 study results are still months out. One call mentioned the FDA traditionally might allow interim analysis at 1/2 enrollment (195 patients). Getting to 195 will take 2-3 more weeks (since over 120 now) +1 month following the last patient. I am now of the opinion it’s better to have more than the 50 patient analysis previously discussed due to statistical risk with too few patients. At first this delay for the S/C trial was a big disappointment, but if the M/M trial (with enrollment thankfully complete with even more than 75 patients) hits endpoints, the company should be fine even if approval requires a Phase 3. Nader has suggested a successful M/M trial would make it an almost certainty to complete a deal with big pharma (if desired) providing great stability for Cytodyn to continue to pursue the plethora of other promising indications. I am very excited about the reduction of tumor cells in the blood after treatment with Leronlimab; Stopping metastasis seems unbelievably big.
I continue to be frustrated by the inability of our country and FDA to figure out a faster way to see if a drug is working. If a drug like Leronlimab is showing a response in 3 days, why does it take 6 months to prove it? Where is the creativity and innovation that America is famous for?
These items hold my attention over the next two weeks:
1) Announcement of distribution agreement on Monday (says Nader on his own internal clock)
2) Up-Listing (by my calculation July 16th is about 6 weeks into the process)
3) Reveal of M/M clinical trial for COVID-19 (maybe after up-listing to get the most benefit, but sooner is better)
4) Wild Card. There is a potential for a licensing deal for an indication (HIV, cancer, NASH) at any time. Many CYDY investor calls have mentioned ongoing discussions. There is a tension for interested companies to wait for more data but, on the other hand, the price goes up or another company can jump in ahead. There seems to be enough promise on HIV and cancer in humans, and NASH and MS in animals that something could happen at any time. Efficacy in COVID would add to the reality of Leronlimab’s promise as a wide spectrum therapy.
My Big picture:
It appears to me that the Severe/Critical Phase 3 study results are still months out. One call mentioned the FDA traditionally might allow interim analysis at 1/2 enrollment (195 patients). Getting to 195 will take 2-3 more weeks (since over 120 now) +1 month following the last patient. I am now of the opinion it’s better to have more than the 50 patient analysis previously discussed due to statistical risk with too few patients. At first this delay for the S/C trial was a big disappointment, but if the M/M trial (with enrollment thankfully complete with even more than 75 patients) hits endpoints, the company should be fine even if approval requires a Phase 3. Nader has suggested a successful M/M trial would make it an almost certainty to complete a deal with big pharma (if desired) providing great stability for Cytodyn to continue to pursue the plethora of other promising indications. I am very excited about the reduction of tumor cells in the blood after treatment with Leronlimab; Stopping metastasis seems unbelievably big.
I continue to be frustrated by the inability of our country and FDA to figure out a faster way to see if a drug is working. If a drug like Leronlimab is showing a response in 3 days, why does it take 6 months to prove it? Where is the creativity and innovation that America is famous for?
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