Coming full circle.
For those of you that have been here for a while, or have the inclination to go back to March and read posts, I was very much against Cytodyn spending time and resources on COVID. At the time, my reasoning was that it was unlikely to work, and would pull our very limited resources away from HIV and Cancer. Both of which I feel very confident in. Clearly I was wrong about our efficacy against COVID.
I still feel that HIV, Cancer & NASH are our biggest opportunities. However, it was the right choice to focus on COVID, not only for the opportunities that it presents (more on this later), but also because we have an opportunity to help mankind. And it very much appears that we are about to do just that.
The next phase of my circle was the acceptance that it might work, but the skepticism in our ability to get approval, overcome BP and get the FDA to acknowledge us. For many, this is the phase you are still in. And that's ok.
I have now entered the phase, where I believe that Leronlimab is going to become the standard of care. And I, for the first time, think it is slightly more likely than not that we get EUA for Mild to Moderate. Here is why:
1) By presenting our data to other countries, we are likely to find at least one leader that cares more about the population of his/her country than the profits from BP.
2) I believe that there will be a gradual acceptance of the fact that being able to arrive at a point where we can tell the population that if you get sick, you get a shot and go home, and your risk of being hospitalized is greatly reduced, will create the confidence needed to jump start the economy.
3) In order to get to the point where governments can categorically state that you get sick, get a shot and get better, we need data from thousands of patients. The fastest way to get this done is with EUA, not more trials.
I believe that our government will come to this realization as well, and it appears to me that Cytodyn is preparing for this by building their scientific advisory board, the distribution deal, etc. Once we have revenue, we are going to move full steam ahead with as many indications as possible. This last fact is the source of my optimism. Becoming the standard of care for COVID, and realizing profits from it are going to dramatically shorten the time it takes us to get clinical data on cancer, NASH, MS, Alzheimer's and many others.
The Mild to moderate data is sufficient to warrant an EUA. Worst case we get a small phase 3, that because of our positive results enrolls VERY quickly. In addition the Interim analysis of Severe is not very far away, and I am extremely confident that the results will be statistically significant and I think, impossible to ignore.
I couldn't be more excited for where we are headed.
For those of you that have been here for a while, or have the inclination to go back to March and read posts, I was very much against Cytodyn spending time and resources on COVID. At the time, my reasoning was that it was unlikely to work, and would pull our very limited resources away from HIV and Cancer. Both of which I feel very confident in. Clearly I was wrong about our efficacy against COVID.
I still feel that HIV, Cancer & NASH are our biggest opportunities. However, it was the right choice to focus on COVID, not only for the opportunities that it presents (more on this later), but also because we have an opportunity to help mankind. And it very much appears that we are about to do just that.
The next phase of my circle was the acceptance that it might work, but the skepticism in our ability to get approval, overcome BP and get the FDA to acknowledge us. For many, this is the phase you are still in. And that's ok.
I have now entered the phase, where I believe that Leronlimab is going to become the standard of care. And I, for the first time, think it is slightly more likely than not that we get EUA for Mild to Moderate. Here is why:
1) By presenting our data to other countries, we are likely to find at least one leader that cares more about the population of his/her country than the profits from BP.
2) I believe that there will be a gradual acceptance of the fact that being able to arrive at a point where we can tell the population that if you get sick, you get a shot and go home, and your risk of being hospitalized is greatly reduced, will create the confidence needed to jump start the economy.
3) In order to get to the point where governments can categorically state that you get sick, get a shot and get better, we need data from thousands of patients. The fastest way to get this done is with EUA, not more trials.
I believe that our government will come to this realization as well, and it appears to me that Cytodyn is preparing for this by building their scientific advisory board, the distribution deal, etc. Once we have revenue, we are going to move full steam ahead with as many indications as possible. This last fact is the source of my optimism. Becoming the standard of care for COVID, and realizing profits from it are going to dramatically shorten the time it takes us to get clinical data on cancer, NASH, MS, Alzheimer's and many others.
The Mild to moderate data is sufficient to warrant an EUA. Worst case we get a small phase 3, that because of our positive results enrolls VERY quickly. In addition the Interim analysis of Severe is not very far away, and I am extremely confident that the results will be statistically significant and I think, impossible to ignore.
I couldn't be more excited for where we are headed.
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