I think Dr Lalezari's statement about why the FDA
Post# of 153822
(Total Views: 581)
Posted On: 07/22/2023 5:50:30 PM
I think Dr Lalezari's statement about why the FDA wasn't open to going with the S/C covid dosing our team wanted in the spring of 2020 really gets to the crux of the problem:
"CytoDyn, fresh off clinical hold, wasn’t in a great position to push back and capitulated."
I don't believe there are conspiracies against tiny drug companies but I do believe that the FDA is generally not nearly as accessible, and obviously not as amenable, to companies like Cytodyn as it is to big pharma.
I'm sure the relationships built up between FDA staff and big pharma companies over time have a lot to do with it and there is a revolving door where employees jump from the FDA to big pharma or vice versa so that likely plays a part as well.
And of course Nader being Nader probably didn't help but that shouldn't have mattered.
Obviously it's still an issue judging from Cyrus' comments last call when he laughed in exasperation talking about the FDA still needing more to clear the hold, including declaring any future HIV plans (would they ask Gilead that?). And Cyrus implied that he didn't want to upset the FDA by starting the NASH trial until the hold is lifted even though we technically could. You gotta play the game. Maybe the new CEO will be a little more savvy in navigating the playing field.
"CytoDyn, fresh off clinical hold, wasn’t in a great position to push back and capitulated."
I don't believe there are conspiracies against tiny drug companies but I do believe that the FDA is generally not nearly as accessible, and obviously not as amenable, to companies like Cytodyn as it is to big pharma.
I'm sure the relationships built up between FDA staff and big pharma companies over time have a lot to do with it and there is a revolving door where employees jump from the FDA to big pharma or vice versa so that likely plays a part as well.
And of course Nader being Nader probably didn't help but that shouldn't have mattered.
Obviously it's still an issue judging from Cyrus' comments last call when he laughed in exasperation talking about the FDA still needing more to clear the hold, including declaring any future HIV plans (would they ask Gilead that?). And Cyrus implied that he didn't want to upset the FDA by starting the NASH trial until the hold is lifted even though we technically could. You gotta play the game. Maybe the new CEO will be a little more savvy in navigating the playing field.
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