How many think a BTD will be our first approval? I
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Posted On: 08/25/2021 7:28:39 PM
Re: Goosebumps #101567
How many think a BTD will be our first approval? I don’t believe we will achieve a BTD towards an accelerated approval until we accomplish our complete HIV BLA and receive approval. We need to establish a drug safety in a BLA submission that shows a lot of time and patients safely taking our drug. Until we use our HIV data this can’t and won’t happen any time soon for a BTD. Our possible BTD chances are on phase 2 trials as they should be. It’s a quicker steppingstone to get an accelerated approval. They usually take a long time to trial. So our long data in HIV will be huge going forward.
The real game changer is this unmet need for a Covid drug in Critical Covid. This could garner us a EUA and some day a BLA for Covid-19. So could the Long Haulers if we are first to the checkered flag on LH’ers to capture that flag or be heads above any other drug that receives a LH’ers EAU. Now Nash and Cancer will have to wait until we get our drug safety record established with HIV. This is how important HIV is to us. Once we establish safety then quick trials on many indications can happen and seek quick approvals. Look at Truvada and averaging 7 approvals each year the last few years as a platform drug with many indications. We have a platform drug in Leronlimab and many indications to trial. Just think… if we apply for the BLA submission and a week or two later we get our Padufa date 6 months later because of our fast track status… we will be well on our way to much bigger things. This is a major advantage we have in 7 year old data that shows our safety in 800 or more people for HIV and another over 400 people lately with covid and all trials.
It makes me dream at night of the good times that are so close. Everyone wants to know when and how soon… if we keep our management on point right now and don’t upset the Apple cart.. Then we look forward to stepping into these big shoes in 2022 and that will be a remarkable year. This is when it all happens… how many approvals in the year 2022? 1…2… 4 or 5? I sit back and just dream some more… let’s get that HIV BLA submitted and my dreams and I am sure many others will turn into reality. As long as we get our padufa date. We know we hit our primary end point. Our data is being reviewed by each section of the 5 sections of the BLA we are submitting in our rolling review. As each section gets reviewed and accepted… we must know that we are ever closer to our dreams. I know I am happy with what Dr. Recknor has done for us. Sad that the FDA uncertified lab IncellDX couldn’t do this for us. Or we would of probably had it done already. Another reason to not vote for that 13d group who want to buy that over priced lab.
The real game changer is this unmet need for a Covid drug in Critical Covid. This could garner us a EUA and some day a BLA for Covid-19. So could the Long Haulers if we are first to the checkered flag on LH’ers to capture that flag or be heads above any other drug that receives a LH’ers EAU. Now Nash and Cancer will have to wait until we get our drug safety record established with HIV. This is how important HIV is to us. Once we establish safety then quick trials on many indications can happen and seek quick approvals. Look at Truvada and averaging 7 approvals each year the last few years as a platform drug with many indications. We have a platform drug in Leronlimab and many indications to trial. Just think… if we apply for the BLA submission and a week or two later we get our Padufa date 6 months later because of our fast track status… we will be well on our way to much bigger things. This is a major advantage we have in 7 year old data that shows our safety in 800 or more people for HIV and another over 400 people lately with covid and all trials.
It makes me dream at night of the good times that are so close. Everyone wants to know when and how soon… if we keep our management on point right now and don’t upset the Apple cart.. Then we look forward to stepping into these big shoes in 2022 and that will be a remarkable year. This is when it all happens… how many approvals in the year 2022? 1…2… 4 or 5? I sit back and just dream some more… let’s get that HIV BLA submitted and my dreams and I am sure many others will turn into reality. As long as we get our padufa date. We know we hit our primary end point. Our data is being reviewed by each section of the 5 sections of the BLA we are submitting in our rolling review. As each section gets reviewed and accepted… we must know that we are ever closer to our dreams. I know I am happy with what Dr. Recknor has done for us. Sad that the FDA uncertified lab IncellDX couldn’t do this for us. Or we would of probably had it done already. Another reason to not vote for that 13d group who want to buy that over priced lab.
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