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Posted On: 10/01/2022 8:14:51 PM
Post# of 148870
I thought this was interesting. Cyrus is stating, publicly, that Amarex's data collection quality is below standards. While being careful to not tip his hand, it looks like he is laying out a good course for Cytodyn to negotiate from strength, and possibly work out a value for what Amarex has cost us. Additionally, his plan keeps the drug moving forward. Now, let's see if he can implement the plan quickly.
Cyrus from the conference call:
"However, as we previously seen hinted in last quarterly call, the data from Amarex is not covered in the industry standard format. While this barrier has extended our desired response Timelines to FDA, it has recently been mitigated by actions from leadership, and I am pleased to announce, that during the month of September, the first of a series of docs are in line for submission to the FDA, and we continue to move as quickly as possible on the remaining items. 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."
Rantes from YMB:
"Cytodyn contracting out the task of auditing the Amarex data is extremely important in determining the dollar value they will want to pursue in arbitration and in a future lawsuit. If the current data set that Amarex is negligent in collecting/processing turns out to not meet the minimum GCP standard for approval, then we need to get into the next HIV/NASH trial and get very solid data from that for the big lawsuit because that will provide a minimum dollar value for damages. It will show that the drug is effective against HIV at a minimum. It seems this management team have the s*** together. Looking forward to the next 12 months."
Cyrus from the conference call:
"However, as we previously seen hinted in last quarterly call, the data from Amarex is not covered in the industry standard format. While this barrier has extended our desired response Timelines to FDA, it has recently been mitigated by actions from leadership, and I am pleased to announce, that during the month of September, the first of a series of docs are in line for submission to the FDA, and we continue to move as quickly as possible on the remaining items. 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."
Rantes from YMB:
"Cytodyn contracting out the task of auditing the Amarex data is extremely important in determining the dollar value they will want to pursue in arbitration and in a future lawsuit. If the current data set that Amarex is negligent in collecting/processing turns out to not meet the minimum GCP standard for approval, then we need to get into the next HIV/NASH trial and get very solid data from that for the big lawsuit because that will provide a minimum dollar value for damages. It will show that the drug is effective against HIV at a minimum. It seems this management team have the s*** together. Looking forward to the next 12 months."
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