Correct, FDA is independent of choosing the DSMC c
Post# of 155038
(Total Views: 539)
Posted On: 12/14/2021 11:29:36 AM
Correct, FDA is independent of choosing the DSMC composition.
To try to have a balanced perspective, FDA is also not necessarily solely responsible for LH trial delay from Phase 2 to Phase 3. We don't know how long it took for CYDY to submit the protocol, or how much pushback/feedback/give-and-take was involved between CYDY and FDA.
I can further see that FDA's main job is to prevent people from promoting drugs without evidence of safety and efficacy. It is not an easy job, when everyone wants to sell things to people who desperately want to feel better. However, on the whole I think the FDA is made up of a bunch of big ego beaurocrats that take things too far in their zeal for "protecting the public." Leronlimab is incredibly safe. The letter was outrageous and harmful.
While I am very frustrated with FDA and think they show very poor judgment on many things (especially as relates to smaller companies like CYDY without any "clout" but preferential treatment for BP), we *have* to kiss their butt and do whatever they say if we want to market our drugs here in the US, so hating them and being outraged doesn't really do us any good.
To try to have a balanced perspective, FDA is also not necessarily solely responsible for LH trial delay from Phase 2 to Phase 3. We don't know how long it took for CYDY to submit the protocol, or how much pushback/feedback/give-and-take was involved between CYDY and FDA.
I can further see that FDA's main job is to prevent people from promoting drugs without evidence of safety and efficacy. It is not an easy job, when everyone wants to sell things to people who desperately want to feel better. However, on the whole I think the FDA is made up of a bunch of big ego beaurocrats that take things too far in their zeal for "protecting the public." Leronlimab is incredibly safe. The letter was outrageous and harmful.
While I am very frustrated with FDA and think they show very poor judgment on many things (especially as relates to smaller companies like CYDY without any "clout" but preferential treatment for BP), we *have* to kiss their butt and do whatever they say if we want to market our drugs here in the US, so hating them and being outraged doesn't really do us any good.
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