So it appears even very knowledgeable posters on Y
Post# of 154105
(Total Views: 705)
Posted On: 11/05/2020 8:53:10 PM
So it appears even very knowledgeable posters on YMB like Thoughtful Investing are reporting that the FDA requested and now have the unblinded data.
Thoughtful Investing4 minutes ago
Short Action: On Wed November 4, short volume constituted an inordinately high 72% of the small 1.7 million total CYDY volume and the share price rose. https://www.otcshortreport.com/company/CYDY
Seems like at least some shorts were covering. Anyway, for the moment, the shorts are doing most of the daily trading. That will likely change upon some sort of approval or other triggering event.
What could that be? Well, as I noted earlier, according to the FDA DSMC Guidance of 2006, it would be rare for FDA to request a copy of the data the DSMC reviewed. Yet, according to Dr. Pourhassan on the conference call today, FDA made such a request of the interim CD012 195 patient data and OWS spoke to Cytodyn about the possibility of helping to manufacture leronlimab in the event of approval. Clearly, leronlimab is squarely within FDA's sights and there is sufficient safety and efficacy data for an EUA if FDA wants to exercise that authority. As Covid 19 gets worse, there will be more and more pressure on FDA to permit leronlimab to be sold.
Maybe FDA can hold out till the 293 patient mark in the CD012 trials and maybe not. We'll see
Either way, when approval is granted, I think it is safe to say we will see an avalanche of new investors.
Thoughtful Investing4 minutes ago
Short Action: On Wed November 4, short volume constituted an inordinately high 72% of the small 1.7 million total CYDY volume and the share price rose. https://www.otcshortreport.com/company/CYDY
Seems like at least some shorts were covering. Anyway, for the moment, the shorts are doing most of the daily trading. That will likely change upon some sort of approval or other triggering event.
What could that be? Well, as I noted earlier, according to the FDA DSMC Guidance of 2006, it would be rare for FDA to request a copy of the data the DSMC reviewed. Yet, according to Dr. Pourhassan on the conference call today, FDA made such a request of the interim CD012 195 patient data and OWS spoke to Cytodyn about the possibility of helping to manufacture leronlimab in the event of approval. Clearly, leronlimab is squarely within FDA's sights and there is sufficient safety and efficacy data for an EUA if FDA wants to exercise that authority. As Covid 19 gets worse, there will be more and more pressure on FDA to permit leronlimab to be sold.
Maybe FDA can hold out till the 293 patient mark in the CD012 trials and maybe not. We'll see
Either way, when approval is granted, I think it is safe to say we will see an avalanche of new investors.
(4)
(0)