Thanks Jake. Cool number 2212 maybe cause 2 is my
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Posted On: 10/01/2022 7:54:06 AM
Thanks Jake. Cool number 2212 maybe cause 2 is my favorite number.
So I agree with you that the potential here is enormous. I'm beginning to think that NSF may also see how big that number could be. In addition, I'm thinking that NSF may begin to see how outrageous Amarex was and how badly they are at fault. Surely all the work Recknor, the CRO for Pharmacovigilance as well as our VPs Joe Meidling and Bernie Cunningham in addition to the Regulatory Consulting Firm and Regulatory Advisory Consulting Group consisting of FDA former regulating officials, all working in unison with "All hands on deck" all working on these issues to get the clinical hold lifted.
For the past 6 months, CytoDyn has been doing what Amarex should have already done and that work is becoming quite revealing. The results so far are a document submission to the FDA in September and more to come. In addition, Cyrus has hired an external, 3rd party, FDA Type GCP Good Clinical Practice Audit that will assess the question of "Had Amarex done what they were contracted to prepare, and that was to prepare a BLA in accordance with FDA guidelines, would leronlimab be approved today?" or more simply, "Had Amarex prepared a BLA in accordance with FDA guidelines, would leronlimab be approved today?"
I don't think Cyrus would be hiring this external FDA Type GCP Audit if the aggregated safety data that they have been collecting and aggregating, across all the Amarex trials was not compelling. Telling of exactly how safe Leronlimab really is and how far Amarex fell from the defined mark of an appropriate CRO and how far from the mark they were from the FDA guidelines in acceptable presentation. Telling of how poorly Amarex presented the data, the quality of their practices of data collection and of data monitoring and of presentation within the BLA, regardless that they were contracted and paid to do it properly.
So because of this thinking, I am led to believe that NSF may decide to forego a future trial if a settlement would be offered them. They may see all this evidence, as presented to them by Sidley Austin, all building up against them, and even agree with it all. If the FDA GCP Audit is favorable for CytoDyn, this is hardline for NSF to make hair stand up on their back. In addition, they may even be made aware or privy to the collusionist efforts of Amarex with 13D and big pharma and they just might see the writing on the wall presented to them by Sidley Austin.
Bottom line, my thinking, NSF may decide to forego the attorney expense of a future trial and just settle.
So I agree with you that the potential here is enormous. I'm beginning to think that NSF may also see how big that number could be. In addition, I'm thinking that NSF may begin to see how outrageous Amarex was and how badly they are at fault. Surely all the work Recknor, the CRO for Pharmacovigilance as well as our VPs Joe Meidling and Bernie Cunningham in addition to the Regulatory Consulting Firm and Regulatory Advisory Consulting Group consisting of FDA former regulating officials, all working in unison with "All hands on deck" all working on these issues to get the clinical hold lifted.
For the past 6 months, CytoDyn has been doing what Amarex should have already done and that work is becoming quite revealing. The results so far are a document submission to the FDA in September and more to come. In addition, Cyrus has hired an external, 3rd party, FDA Type GCP Good Clinical Practice Audit that will assess the question of "Had Amarex done what they were contracted to prepare, and that was to prepare a BLA in accordance with FDA guidelines, would leronlimab be approved today?" or more simply, "Had Amarex prepared a BLA in accordance with FDA guidelines, would leronlimab be approved today?"
I don't think Cyrus would be hiring this external FDA Type GCP Audit if the aggregated safety data that they have been collecting and aggregating, across all the Amarex trials was not compelling. Telling of exactly how safe Leronlimab really is and how far Amarex fell from the defined mark of an appropriate CRO and how far from the mark they were from the FDA guidelines in acceptable presentation. Telling of how poorly Amarex presented the data, the quality of their practices of data collection and of data monitoring and of presentation within the BLA, regardless that they were contracted and paid to do it properly.
So because of this thinking, I am led to believe that NSF may decide to forego a future trial if a settlement would be offered them. They may see all this evidence, as presented to them by Sidley Austin, all building up against them, and even agree with it all. If the FDA GCP Audit is favorable for CytoDyn, this is hardline for NSF to make hair stand up on their back. In addition, they may even be made aware or privy to the collusionist efforts of Amarex with 13D and big pharma and they just might see the writing on the wall presented to them by Sidley Austin.
Bottom line, my thinking, NSF may decide to forego the attorney expense of a future trial and just settle.
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