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Posted On: 03/27/2021 7:37:12 PM
Post# of 148908
I am sorry for the interruption into your quest for a partner or help in some way for the Long Haulers trial or as they are trying to call it now as Long Covid.
Let me ask you this... would Dr Patterson be using Leronlimab by itself until it doesn’t show enough progress? Would he then try to use it with other drugs that are already approved? He is trying to be someone that is running a Internet clinic for the help to the LH population and not performing a approved FDA drug trial. He is going another direction from we are going. We need to test our little molecule for what it can do in a full FDA qualified trial. Finding out what we can do alone is paramount to continuing covid trials going forward. Just because we might get a Conditional EUA doesn’t mean we are stopping with covid trials. Unless we slam it out of the park of coarse. We are looking for more than a EUA and hope to achieve a BLA across all of covid like Gilead has already done. CD-16 was designed to succeed in a BLA not just a EUA.
When seeking a partner going foreword you have to question who is worthy or should we just let someone with a lot of funds trial Leronlimab with their ideas? This was brought foreword in the last CC in a round about way.
I noticed this last week the NIH gave 1 billion dollars to study Long Covid to a reputable facility that could do a lot of testing and trials to further any drug they choose. This money was given to the Mayo Clinic. This would be our best option as a second option at trials that doesn’t cost the investor or the company while they choose how to design a trial for Long Covid. It would be a win win situation for both us investors and for the people of this country to see the Mayo Clinic choose to study our effect at more than one indication for Covid. What would be nice is if we knew if they were accepting applications for drugs to study in trials and if we would qualify.
The need for us to know what we can do alone in the trials are still where we need to focus. I like the fact that we are doing 8 weekly doses of Leronlimab and have constant monitoring as the trial progresses for long covid. My understanding is we will be monitoring the patients with daily updates of their symptoms and progression or reduced symptoms as the trial progresses. I hope the bio markers are the best part of the expected weekly lab work and what I believe is the lab work that was chosen by not just Cytodyn but help of the FDA in design. That’s what I heard in the conference calls. That the FDA helped design our trial end points to help us. This sounds like sound advice well received by our management team and leads to a better relationship with the FDA. We can talk all day about directions and partners but in the end. We have a couple of trials already in the works in the CD-16 and CD-17 that can be approved any day now and Long haulers has probably already completely filled the 50 patients. We are well on our way to a quick understanding of the strength of trial needed to get for sure an EUA if we don’t get one any day now in the next couple of weeks from filing the conditional EUA with the FDA two weeks ago. That possibility is still there. I am not counting on it but crazier things have happened in our world. It would be a blessing if that happens the next week or two. I know that our little company struggles at times but financially we hope to not use our remaining shares for money for the trials. A little revenue would be golden for our trials. I believe we see revenue soon. How soon is the question I struggle with. Let’s hope it is right around the corner...
Let me ask you this... would Dr Patterson be using Leronlimab by itself until it doesn’t show enough progress? Would he then try to use it with other drugs that are already approved? He is trying to be someone that is running a Internet clinic for the help to the LH population and not performing a approved FDA drug trial. He is going another direction from we are going. We need to test our little molecule for what it can do in a full FDA qualified trial. Finding out what we can do alone is paramount to continuing covid trials going forward. Just because we might get a Conditional EUA doesn’t mean we are stopping with covid trials. Unless we slam it out of the park of coarse. We are looking for more than a EUA and hope to achieve a BLA across all of covid like Gilead has already done. CD-16 was designed to succeed in a BLA not just a EUA.
When seeking a partner going foreword you have to question who is worthy or should we just let someone with a lot of funds trial Leronlimab with their ideas? This was brought foreword in the last CC in a round about way.
I noticed this last week the NIH gave 1 billion dollars to study Long Covid to a reputable facility that could do a lot of testing and trials to further any drug they choose. This money was given to the Mayo Clinic. This would be our best option as a second option at trials that doesn’t cost the investor or the company while they choose how to design a trial for Long Covid. It would be a win win situation for both us investors and for the people of this country to see the Mayo Clinic choose to study our effect at more than one indication for Covid. What would be nice is if we knew if they were accepting applications for drugs to study in trials and if we would qualify.
The need for us to know what we can do alone in the trials are still where we need to focus. I like the fact that we are doing 8 weekly doses of Leronlimab and have constant monitoring as the trial progresses for long covid. My understanding is we will be monitoring the patients with daily updates of their symptoms and progression or reduced symptoms as the trial progresses. I hope the bio markers are the best part of the expected weekly lab work and what I believe is the lab work that was chosen by not just Cytodyn but help of the FDA in design. That’s what I heard in the conference calls. That the FDA helped design our trial end points to help us. This sounds like sound advice well received by our management team and leads to a better relationship with the FDA. We can talk all day about directions and partners but in the end. We have a couple of trials already in the works in the CD-16 and CD-17 that can be approved any day now and Long haulers has probably already completely filled the 50 patients. We are well on our way to a quick understanding of the strength of trial needed to get for sure an EUA if we don’t get one any day now in the next couple of weeks from filing the conditional EUA with the FDA two weeks ago. That possibility is still there. I am not counting on it but crazier things have happened in our world. It would be a blessing if that happens the next week or two. I know that our little company struggles at times but financially we hope to not use our remaining shares for money for the trials. A little revenue would be golden for our trials. I believe we see revenue soon. How soon is the question I struggle with. Let’s hope it is right around the corner...
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