MGK said: "Our track record was flawed because
Post# of 154601
(Total Views: 739)
Posted On: 12/12/2022 8:44:55 AM
MGK said:
"Our track record was flawed because we did not have proof that Leronlimab was safe and therefore we could not say it was effective either because, the only one in the room that can say it is safe is the FDA."
Saying our track record is flawed and that we did not have proof Leronlimab is safe sounds like something out of a basher's playbook. Further, safe and effective are two different things. You can have a safe drug that isn't effective, and an effective drug that isn't really all that safe. They're two important ingredients in the same recipe, but just because one is out of whack doesn't render the other, or the end product, worthless.
Our track record wasn't flawed because we couldn't prove it was safe. Every trial has shown it to be safe. The problem is the FDA wants safety data compiled and submitted in specific ways throughout the process and Amarex did a shit job of keeping track of the trial data. This world class fuck-up meant that our BLA looked like shit, and we clearly didn't have everything compiled, categorized, and submitted properly to the FDA otherwise we'd likely have no hold. Cyrus and team know where the deficiencies are because the FDA has laid out what they need from Cytodyn. They don't have to run any new trials, they just need to go through the process of redoing things in the correct way.
As for efficacy they just need to start designing and running better, more robust trials with a decent CRO. Partner, no partner, it doesn't change the requirements. They need well designed trials that hit end points.
It would appear we have people in place that understand all of this, so I'm excited about the future of my investment. It's all there to be had, it's just going to require stewardship, money, and time. I believe we have strong leadership to steer the ship in the right direction. Money will come because Leronlimab continues to show it has the potential to be a giant, and with money we'll have all the time we need.
"Our track record was flawed because we did not have proof that Leronlimab was safe and therefore we could not say it was effective either because, the only one in the room that can say it is safe is the FDA."
Saying our track record is flawed and that we did not have proof Leronlimab is safe sounds like something out of a basher's playbook. Further, safe and effective are two different things. You can have a safe drug that isn't effective, and an effective drug that isn't really all that safe. They're two important ingredients in the same recipe, but just because one is out of whack doesn't render the other, or the end product, worthless.
Our track record wasn't flawed because we couldn't prove it was safe. Every trial has shown it to be safe. The problem is the FDA wants safety data compiled and submitted in specific ways throughout the process and Amarex did a shit job of keeping track of the trial data. This world class fuck-up meant that our BLA looked like shit, and we clearly didn't have everything compiled, categorized, and submitted properly to the FDA otherwise we'd likely have no hold. Cyrus and team know where the deficiencies are because the FDA has laid out what they need from Cytodyn. They don't have to run any new trials, they just need to go through the process of redoing things in the correct way.
As for efficacy they just need to start designing and running better, more robust trials with a decent CRO. Partner, no partner, it doesn't change the requirements. They need well designed trials that hit end points.
It would appear we have people in place that understand all of this, so I'm excited about the future of my investment. It's all there to be had, it's just going to require stewardship, money, and time. I believe we have strong leadership to steer the ship in the right direction. Money will come because Leronlimab continues to show it has the potential to be a giant, and with money we'll have all the time we need.
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