Did we learn anything? I don’t feel there was a conspiracy by either group being the FDA or the DSMB. We learned some valuable lessons from the trials. Placing blame does no good. I hoped we would of performed perfectly the first time but a fledgling biotech isn’t going to knock it out of the park every time. Now is not the time to look back at “what if” but to look foreword and change our path forward to actually bring foreword what we have learned. We have learned some valuable lessons.
I believe we have done that with all 3 newest trials. Long Hauler with an 8 dose/8 week trial. Total of 12 weeks. This will be exciting to see how it performs as it is interactive daily communication for the trial participants to gauge their symptoms. Should provide a huge understanding of if 8 doses is enough or is it like HIV for some people and in order to keep it mangaged and under control it might take longer or maybe it’s a forever treatment? The value of this trial will show by all the bio markers and personal symptoms. This to me is the most important trial for what we can learn about Leronlimab’s effect without being as life saving as the other trials.
Then you have two other important trials in CD-16&17. I don’t know who is responsible for the separation of these two groups for over or under 65 yrs old. But it’s a great separation. Being that the biggest impact the the immune system is being over 65 yrs old. Why not give these people an additional dose and start with an IV for the first dose then 2 injections. I don’t know who at the last minute came up with this idea but it looks like it will be a huge time saver for these trials if it pans out to saving more lives for the compromised immune systems in the older people. CYDY already had the CD-16 protocol approved until this separation idea came up. As for CD-16 for under 65 yrs old. I see this as the trial that gives us our BLA in covid. It is designed to get us over the finish line in the easiest way possible. 6 days early on hospital stay. We might of done alright in a primary end point of mortality for under 65 and had a strong p value. Why risk it when we can get a easy primary end point and somewhat guarantee our success. This trial is our bread and butter for BLA and hopefully guaranteed revenue if we somehow and I don’t want to say it.... Don’t get an EUA in the next week or so. I just don’t see how they can’t give us a EUA and start saving lives now. I feel we are on the right path foreword and look forward to our future as much as I ever did. You just have to believe in the science. Once you believe... you can’t see it any other way. We got this!
I believe we have done that with all 3 newest trials. Long Hauler with an 8 dose/8 week trial. Total of 12 weeks. This will be exciting to see how it performs as it is interactive daily communication for the trial participants to gauge their symptoms. Should provide a huge understanding of if 8 doses is enough or is it like HIV for some people and in order to keep it mangaged and under control it might take longer or maybe it’s a forever treatment? The value of this trial will show by all the bio markers and personal symptoms. This to me is the most important trial for what we can learn about Leronlimab’s effect without being as life saving as the other trials.
Then you have two other important trials in CD-16&17. I don’t know who is responsible for the separation of these two groups for over or under 65 yrs old. But it’s a great separation. Being that the biggest impact the the immune system is being over 65 yrs old. Why not give these people an additional dose and start with an IV for the first dose then 2 injections. I don’t know who at the last minute came up with this idea but it looks like it will be a huge time saver for these trials if it pans out to saving more lives for the compromised immune systems in the older people. CYDY already had the CD-16 protocol approved until this separation idea came up. As for CD-16 for under 65 yrs old. I see this as the trial that gives us our BLA in covid. It is designed to get us over the finish line in the easiest way possible. 6 days early on hospital stay. We might of done alright in a primary end point of mortality for under 65 and had a strong p value. Why risk it when we can get a easy primary end point and somewhat guarantee our success. This trial is our bread and butter for BLA and hopefully guaranteed revenue if we somehow and I don’t want to say it.... Don’t get an EUA in the next week or so. I just don’t see how they can’t give us a EUA and start saving lives now. I feel we are on the right path foreword and look forward to our future as much as I ever did. You just have to believe in the science. Once you believe... you can’t see it any other way. We got this!
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