Quote:"13:05: Turning now to the BLA for HIV, During the course of last few months, we have had the chance to get a much clearer look at the state of the clinical data collected by Amarex . This showed us to perform an internal feasibility assessment, on the clinical portion of the BLA, With a key question of understanding, if the data would withstand , what is commonly referred to as a good clinical practice, or a GCP audit, which is precisely what we would expect the FDA to perform during the BLA review Process. And as a result of our internal assessment, we decided to perform external audit of that same data and we expect to receive those results of that audit in near term. And those results will inform our next steps with the BLA. I want to make clear, that this audit is not a question of the performance of Leronlimab in clinical trials . Rather, it is an assessment of the quality of the data collection and monitoring performed by Amarex . And We are performing this purely To assess the probability that if the BLA submission had been completed, that it would pass an FDA type GCP audit ."
And this goal, to assess the quality of the data collection and monitoring performed by Amarex is coming to light. And the determination of the probability that had the submission of the BLA for HIV been completed, would it have passed an FDA Type GCP, Good Clinical Practice Audit is being summed up . And we have received the answer today, and that answer is a resounding, NO. These FDA External Enforcing Auditors are by far and wide, completely taking Amarex by storm and by surprise . Operation Storm. They are being looked at from every which angle, and every last nuance of delinquency is being discovered and brought to light. Amarex thought they were above the law. Yeah, maybe when there was no law. But Cyrus brought the law to them. And the Enforcer is getting it done . The Investigator's Brochure has been submitted , the Warning Banner Removed, the ISS and ISE (Integrated Summaries of Safety and Effectiveness) are done and submitted according to FDA Type GCP format. Without an OK from the External Auditor, CytoDyn would not have submitted these documents, and that is proof that the data has been aggregated by CytoDyn's Internal Audit Committee in accordance with GCP format . Last week, a tangential law suit gets dismissed? These Auditors are working magic for CytoDyn, I mean havoc for Amarex. Amarex won't get dismissed because, CytoDyn is the Plantiff . Amarex is getting the handcuffs. Are they squirming yet? Pissing in their pants yet? Can't sleep at night Amarex? Who's coming to your side Amarex, to your aid? Those who paid you? to get you to commit your dirty deeds of sabotage upon CytoDyn and Leronlimab? Are you going to implicate them to get your self out? No? Are you going to tell them you are in trouble?, so they can make more trouble for CytoDyn before the judgement hammer falls?, so that possibly you can escape? Not. You're in deep shit Amarex. Quick sand even. You can't move in quick sand Amarex, you just keep sinking and sinking and you can't breathe. You better get your ass in gear if you want to see another day. But that ain't happening. You got friends who paid you? Now is the time to act. Go ahead. Let's see if you want to play the game of Diversion. Let's see.
Patience folks...
Hang in there.
Slowly but surely, we are getting there. Monday should be interesting...
https://www.reddit.com/r/LeronLimab_Times/com...;context=3
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