From the conference call in June 2022:
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."
Certainly, Amarex can not be pleased with any of this. Had Nader been in charge, it is very doubtful, CytoDyn would even be in business at this point, especially with this hold in place. Cyrus handled this situation brilliantly. When Cyrus came into power, it was an emergence of control. All of us who witnessed it, saw an out of control, violent disaster, being tamed, being controlled and handled with finesse. The company was wildly out of control, but he wrapped his arms around it and grabbed hold of the situation and then found a means to attack the instigator.
From the 10/31/22 Webcast, Cyrus summarizes:
"3:38: Due to our concerns with the CRO, we commissioned 3 independent audits of the clinical data, in addition to our own internal feasibility assessment of the same data*. Each of these audits, including the investigation of the CRO's performance and Data Management, Monitoring and Quality. We found that these multiple audits, we have concluded that, a* BLA faces a severe risk of receiving a complete (negative) response letter from the FDA*, which means* non approval*.*
4:05: Now, with that being said, we are confident that the primary findings of the study are sound. Since these assessments did not find any serious integrity issues at the level of the clinical trial sites, and due to the CRO's inadequate process and performance around the Monitoring and Oversight of the Data*, there are* significant challenges to meeting the high bar of passing an FDA GCP Audit*.*
4:27: In light of these factors, and the substantial costs associated with remediating the data*, or in* conducting entirely new trials in this population, we decided to voluntarily withdraw the BLA for the HIV MDR population*. We notified the FDA of this decision on October 25, 2022. Given the* considerable financial resources that the company has put into the clinical development program for this indication*, we did not make this decision lightly.*
4:54: It was only after an extensive review of the assessment by the External Auditors, our own Internal Assessment, Expertise from our Board and Advice from our Regulatory Consultants, that we came to this decision.
5:06: Now, we realize that this may be disappointing to some, however, it is critical to note that, this decision does not under cut the drugs performance in clinical trials, as the audit results do not change the fact that the Primary Endpoint was met*. By the time we* publish those positive results in the Peer Reviewed Journal soon*, we believe it will* help others in the medical and clinical communities further understand the enormous potential of Leronlimab."
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."
Certainly, Amarex can not be pleased with any of this. Had Nader been in charge, it is very doubtful, CytoDyn would even be in business at this point, especially with this hold in place. Cyrus handled this situation brilliantly. When Cyrus came into power, it was an emergence of control. All of us who witnessed it, saw an out of control, violent disaster, being tamed, being controlled and handled with finesse. The company was wildly out of control, but he wrapped his arms around it and grabbed hold of the situation and then found a means to attack the instigator.
From the 10/31/22 Webcast, Cyrus summarizes:
"3:38: Due to our concerns with the CRO, we commissioned 3 independent audits of the clinical data, in addition to our own internal feasibility assessment of the same data*. Each of these audits, including the investigation of the CRO's performance and Data Management, Monitoring and Quality. We found that these multiple audits, we have concluded that, a* BLA faces a severe risk of receiving a complete (negative) response letter from the FDA*, which means* non approval*.*
4:05: Now, with that being said, we are confident that the primary findings of the study are sound. Since these assessments did not find any serious integrity issues at the level of the clinical trial sites, and due to the CRO's inadequate process and performance around the Monitoring and Oversight of the Data*, there are* significant challenges to meeting the high bar of passing an FDA GCP Audit*.*
4:27: In light of these factors, and the substantial costs associated with remediating the data*, or in* conducting entirely new trials in this population, we decided to voluntarily withdraw the BLA for the HIV MDR population*. We notified the FDA of this decision on October 25, 2022. Given the* considerable financial resources that the company has put into the clinical development program for this indication*, we did not make this decision lightly.*
4:54: It was only after an extensive review of the assessment by the External Auditors, our own Internal Assessment, Expertise from our Board and Advice from our Regulatory Consultants, that we came to this decision.
5:06: Now, we realize that this may be disappointing to some, however, it is critical to note that, this decision does not under cut the drugs performance in clinical trials, as the audit results do not change the fact that the Primary Endpoint was met*. By the time we* publish those positive results in the Peer Reviewed Journal soon*, we believe it will* help others in the medical and clinical communities further understand the enormous potential of Leronlimab."
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