On the surface it appears the FDA is at fault for
Post# of 154089
(Total Views: 525)
Posted On: 03/10/2021 10:04:48 AM
On the surface it appears the FDA is at fault for green-lighting the trial every step of the way despite the demographic imbalance of age and level of disease progression. How could they not know this would be an issue at the end?
But what about the role of the DSMB? Isn't their function to review and advise CytoDyn through the trial process? They raised no flags over these shortcomings as far as we know. According to reports from our CEO, all they had to offer was "keep on doing what you're doing."
And how about the "experts" with all this history of leading BP products through trials and into approval who were hired by Nader to "steer us through the process?" How did this imbalance slip by these people entrusted to steer us around potential land mines and into the end zoze? They steered us right into the ditch. Sure, that's probably where the damn FDA placed the checkered flag, but all of the experts entrusted at several points along the way failed us miserably.
But in the end no one failed more miserably than I did. I never should have invested so heavily in a start-up bio with a green CEO who has a penchant for hyperbole that ruffles feathers better left unruffled in a sector dominated by BP corruption at every turn. The writing has been on the wall with every inferior product the FDA has approved along the way. My poor investment choice has left a massive hole I blew in my account that may never heal.
Anybody got an extra tourniquet?
But what about the role of the DSMB? Isn't their function to review and advise CytoDyn through the trial process? They raised no flags over these shortcomings as far as we know. According to reports from our CEO, all they had to offer was "keep on doing what you're doing."
And how about the "experts" with all this history of leading BP products through trials and into approval who were hired by Nader to "steer us through the process?" How did this imbalance slip by these people entrusted to steer us around potential land mines and into the end zoze? They steered us right into the ditch. Sure, that's probably where the damn FDA placed the checkered flag, but all of the experts entrusted at several points along the way failed us miserably.
But in the end no one failed more miserably than I did. I never should have invested so heavily in a start-up bio with a green CEO who has a penchant for hyperbole that ruffles feathers better left unruffled in a sector dominated by BP corruption at every turn. The writing has been on the wall with every inferior product the FDA has approved along the way. My poor investment choice has left a massive hole I blew in my account that may never heal.
Anybody got an extra tourniquet?
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