MGK: I fear you may be right about the FDA requiri
Post# of 153767
(Total Views: 538)
Posted On: 07/24/2023 11:00:32 AM
MGK: I fear you may be right about the FDA requiring a new HIV trial to reestablish safety for LL. I have to admit that the biggest flaw in my accelerated approval scenario related to requests for benefit risk assessments and HIV clinical trial protocols would be the assumption of FDA assistance in making LL available to the HIV MDR patients in need, while your scenario of the agency requiring a new phase 1 safety trial would effectively get LL's HIV clinical status back to 2015 would be entirely consistent with the agency's history of delaying LL whenever possible.
While the theory that the FDA was demanding submission of a HIV trial protocol just out of idle curiosity always seemed (at least to me) a stretch even by FDA standards, while your theory, which would likely result in an even longer delay in getting the hold lifted, does seem much more plausible, notwithstanding that I could not find a precedent for the agency requiring a biotech to start over in demonstrating the safety of a drug which had already completed multiple trials in various phases.
Anyway, we'll all be put out of our misery soon, at least from a curiosity point of view. I'm still clinging to a thread of hopefulness that there is a sane explanation for the risk assessment/protocol gymnastics, but I am definitely worried that the FDA has likely stayed true to form.
While the theory that the FDA was demanding submission of a HIV trial protocol just out of idle curiosity always seemed (at least to me) a stretch even by FDA standards, while your theory, which would likely result in an even longer delay in getting the hold lifted, does seem much more plausible, notwithstanding that I could not find a precedent for the agency requiring a biotech to start over in demonstrating the safety of a drug which had already completed multiple trials in various phases.
Anyway, we'll all be put out of our misery soon, at least from a curiosity point of view. I'm still clinging to a thread of hopefulness that there is a sane explanation for the risk assessment/protocol gymnastics, but I am definitely worried that the FDA has likely stayed true to form.
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