From 3/31/22 Conference Call: Scott Kelly 9:00: 2
Post# of 148235
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Posted On: 02/27/2023 6:06:39 AM
From 3/31/22 Conference Call:
In short, without the hold, CytoDyn never would have proved to the FDA in the language of the FDA, which is the FDA Type Good Clinical Practice Format that Leronlimab was safe. The data was not aggregated by Amarex. It was not in the format required by US FDA, but thanks to the hold, CytoDyn was successful in obtaining the raw data and aggregating it and then supplying all of the required documents in the format which the FDA expects, Type GCP.
What I'm not getting Sean, is are you saying CytoDyn requested the clinical hold or are you saying that it was imposed upon CytoDyn by the FDA? A volunteer effort being that CytoDyn recommended to the FDA that the FDA impose a clinical hold upon them?
So since it was imposed by the FDA, it has to be lifted by the FDA, which means that the FDA set forth what was necessary from their vantage point, to be done by CytoDyn to get the hold lifted. Then the FDA would have to review all the work and determine if CytoDyn has fulfilled the necessary requirements and that means that the FDA would have to review all those CytoDyn submissions and by doing so, the FDA would learn first hand of Leronlimab's true safety profile and true level of efficacy. Once the hold lifts, it will never be re-instated, forged in steel.
Quote:
Scott Kelly 9:00: 2 cardiac events led to pausing CD16. they don't know if these patients are LL or placebo. They want to pause the trial b/c our experience w/LL was in healthy volunteers and not in critically ill Covid 19 population of sick individuals. They have a preplanned DSMC meeting data safety monitoring committee in early April for both studies. So upon clearance of the DSMC we plan on removing the pause. We are in communication with ANVISA and the FDA and reported the events to each agency, but this was CytoDyn's decision. Full clinical hold on US IND Covid 19, and partial clinical hold for IND for HIV. The FDA wants aggregated safety data across all indications as our prior CRO was not aggregating safety data. We will correct this. We believe this is a solvable problem. We have contracted with a new pharmaco-vigilance CRO to move forward. So we expect about an 8-12 week, (June-July 2022), timeline and seek advice from the FDA.
In short, without the hold, CytoDyn never would have proved to the FDA in the language of the FDA, which is the FDA Type Good Clinical Practice Format that Leronlimab was safe. The data was not aggregated by Amarex. It was not in the format required by US FDA, but thanks to the hold, CytoDyn was successful in obtaining the raw data and aggregating it and then supplying all of the required documents in the format which the FDA expects, Type GCP.
What I'm not getting Sean, is are you saying CytoDyn requested the clinical hold or are you saying that it was imposed upon CytoDyn by the FDA? A volunteer effort being that CytoDyn recommended to the FDA that the FDA impose a clinical hold upon them?
So since it was imposed by the FDA, it has to be lifted by the FDA, which means that the FDA set forth what was necessary from their vantage point, to be done by CytoDyn to get the hold lifted. Then the FDA would have to review all the work and determine if CytoDyn has fulfilled the necessary requirements and that means that the FDA would have to review all those CytoDyn submissions and by doing so, the FDA would learn first hand of Leronlimab's true safety profile and true level of efficacy. Once the hold lifts, it will never be re-instated, forged in steel.
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