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Posted On: 12/26/2022 4:06:09 PM
Post# of 149002
Re: craigakess #131971
On 10/4 an additional page was submitted to the court(and was posted)- that page 16 had 4 requests for the arbitrator.
There were references in the Sidley filing from April from the master service agreement about the conditions that were set in place in the event of a conflict of work product. In the event of a conflict, the parties could go to outside binding arbitration. Each side would be assigned a mediator. The parties would work through mediation to try to work out the issue, then there is also a main arbitor that would make rulings.
In the master service agreement, it did state that if there was an issue, all that could be recovered was the payments made to Amarex, unless it was found that there was gross negligence and that the drug was proven safe & effective. At that point other financial remedies could be requested.
So page 16, from 10/4, requested 4 things.
#1- that the arbitor makes a ruling on gross negligence.
#2-4 are requesting for further financial remedies based on gross negligence.
Someone also posted the time line. Apparently on 9/28 both parties reported from mediation that no settlement was reached. 6 days later Sidley files page 16. There are 3 dates in the future that were noted. Each about 45-60 days apart , 1st date was for a response from Amarex/NSF, 2nd date was a chance for rebuttle from Sidley/CYDY and 3rd date was for Amarex/NSF to respond to the rebuttle. If no settlement then it goes to final ruling from the arbitrator in March 2023.
Did you forget the recent webcast on 10/31/22:
There were references in the Sidley filing from April from the master service agreement about the conditions that were set in place in the event of a conflict of work product. In the event of a conflict, the parties could go to outside binding arbitration. Each side would be assigned a mediator. The parties would work through mediation to try to work out the issue, then there is also a main arbitor that would make rulings.
In the master service agreement, it did state that if there was an issue, all that could be recovered was the payments made to Amarex, unless it was found that there was gross negligence and that the drug was proven safe & effective. At that point other financial remedies could be requested.
So page 16, from 10/4, requested 4 things.
#1- that the arbitor makes a ruling on gross negligence.
#2-4 are requesting for further financial remedies based on gross negligence.
Someone also posted the time line. Apparently on 9/28 both parties reported from mediation that no settlement was reached. 6 days later Sidley files page 16. There are 3 dates in the future that were noted. Each about 45-60 days apart , 1st date was for a response from Amarex/NSF, 2nd date was a chance for rebuttle from Sidley/CYDY and 3rd date was for Amarex/NSF to respond to the rebuttle. If no settlement then it goes to final ruling from the arbitrator in March 2023.
Did you forget the recent webcast on 10/31/22:
Quote:
2:53: Thank you Christina. Good Morning Everyone and thank you for joining us. As many of you know, since July of 2021, CytoDyn has worked on resubmitting parts of its BLA for Leronlimab and HIV multidrug resistant or MDR population. As part of our rolling submission, CytoDyn completed and submitted sections of the BLA related to the non-clinical studies and the product and manufacturing information or CMP / CNC? section.
And Thus, in November, (2021), we have worked on completing the clinical study section of the application and we have been trying to do this, despite not having full access to the electronic database from the CRO engaged, managed studies. As we have previously discussed, we have filed a claim against the CRO, seeking damages resulting from the breach of the Master Services Agreement.
Quote:
It is important to note, that substantially all of the data requested by the FDA that lifts the clinical hold, are items that Amarex was contracted by CytoDyn to prepare, but failed to do so. As a result, CytoDyn has taken on all of these responsibilities internally over the last 6 months. Along these lines, we have also recently completed the warning letter close out process with the office of prescription drug promotion, and we look forward to continue to improve our relationship with the FDA at all levels.
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 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.
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