Good question. I'm not sure how much "data" will be helpful on this, but a few thoughts.
- BLA acceptance by the FDA is a declaration that the submission is complete and they have the needed information to evaluate the application. In CYDY's case, for HIV combo, immeasurable time has been spent with the FDA at this point essentially litigating the contents of the BLA. Thus, I have little doubt that it will be accepted.
- Acceptance starts the clock for what's called a PDUFA date, which in short is the date by which the FDA commits to return a verdict on the application. In recent times, the FDA has often come in with approvals prior to the PDUFA date, occasionally well before. I think this should be the case with CYDY for combo HIV, again because of the time already spent on the clinical portion as well as the rolling review of the preclinical portion.
- Statistically (and don't quote me on this, since I'm not going to go back to find my sources at the moment), something like 90% of drugs that submit a BLA are eventually approved. That number is much lower for the first submission, and often the FDA issues a complete response letter (CRL) to ask for weaknesses or omissions to be corrected. This can be costly, takes a lot of time, and is often related to the CMC (manufacturing) portion. The fact that the company is working with Amarex and AGC for the submission and manufacturing is comforting, as they both have significant experience in getting drugs through the approval process. What you don't want is an IMMU situation, where the manufacturing facility they built didn't meet code in certain instances, and they got a CRL. I don't think this will be an issue because the company is doing very little in-house.
- Again, statistically and not cited, the vast majority of drugs that do not eventually get approved are denied on the basis of safety concerns. That's a non-issue here, and the efficacy isn't questioned either.
As a result, my personal opinion is that getting the BLA filed - and filed correctly the first time - will result in a pretty speedy acceptance and approval. Particularly if DJT latches on to this drug and realizes that not only is it useful in COVID-19, but also could be very useful in his war on HIV.
Last, I know that there are lies, damn lies, and statistics (Twain), but this is from memory on significant research I did maybe two years back. Use and quote at your own risk!
- BLA acceptance by the FDA is a declaration that the submission is complete and they have the needed information to evaluate the application. In CYDY's case, for HIV combo, immeasurable time has been spent with the FDA at this point essentially litigating the contents of the BLA. Thus, I have little doubt that it will be accepted.
- Acceptance starts the clock for what's called a PDUFA date, which in short is the date by which the FDA commits to return a verdict on the application. In recent times, the FDA has often come in with approvals prior to the PDUFA date, occasionally well before. I think this should be the case with CYDY for combo HIV, again because of the time already spent on the clinical portion as well as the rolling review of the preclinical portion.
- Statistically (and don't quote me on this, since I'm not going to go back to find my sources at the moment), something like 90% of drugs that submit a BLA are eventually approved. That number is much lower for the first submission, and often the FDA issues a complete response letter (CRL) to ask for weaknesses or omissions to be corrected. This can be costly, takes a lot of time, and is often related to the CMC (manufacturing) portion. The fact that the company is working with Amarex and AGC for the submission and manufacturing is comforting, as they both have significant experience in getting drugs through the approval process. What you don't want is an IMMU situation, where the manufacturing facility they built didn't meet code in certain instances, and they got a CRL. I don't think this will be an issue because the company is doing very little in-house.
- Again, statistically and not cited, the vast majority of drugs that do not eventually get approved are denied on the basis of safety concerns. That's a non-issue here, and the efficacy isn't questioned either.
As a result, my personal opinion is that getting the BLA filed - and filed correctly the first time - will result in a pretty speedy acceptance and approval. Particularly if DJT latches on to this drug and realizes that not only is it useful in COVID-19, but also could be very useful in his war on HIV.
Last, I know that there are lies, damn lies, and statistics (Twain), but this is from memory on significant research I did maybe two years back. Use and quote at your own risk!
10
