(Total Views: 388)
Posted On: 03/02/2020 2:31:30 PM
Post# of 153941
To the IH board:
Email your questions to NP for the conference call. Here is his response to a question that was posted on this board:
From: skezan
Sent: Monday, March 2, 2020 7:53 AM
To: Nader Pourhassan <npourhassan@cytodyn.com>
Subject: CC this Thursda
Question about the manufacturing (CMC) section for you to address in the conference call. (copied from the IH message board)
The FDA request for additional stability has been known for 6 months (since September/October) and the final stability time point was communicated as due in December. Even if you dismiss the question of why this stability request was a surprise, it is very hard to understand why the manufacturing section was not available in January at the latest as the entire submission should have been written and triple checked just waiting for the final stability checkpoint data to be entered into the submission.
Approved manufacturing is needed if we get a very positive BTD response with a confirmatory trial requirement and if that is the case, this Multiple month long delay will be costly for investors and patients.
We need info this week in CMC section as info on that section has been eerily quiet.
From NP:
I will read these questions and answer them if no one asks these questions
Craig: Please make sure you have the list of questions below ready for us to answer in the Q/A session of our call on Thursday
With best regards
Nader
Nader Pourhassan, PhD
Director, President & CEO
CytoDyn Inc. (www.cytodyn.com)
1111 Main Street, Suite 660
Vancouver, Washington 98660
(360)980-8524 Ext. 1 - Work
(360)980-8549 -
Email your questions to NP for the conference call. Here is his response to a question that was posted on this board:
From: skezan
Sent: Monday, March 2, 2020 7:53 AM
To: Nader Pourhassan <npourhassan@cytodyn.com>
Subject: CC this Thursda
Question about the manufacturing (CMC) section for you to address in the conference call. (copied from the IH message board)
The FDA request for additional stability has been known for 6 months (since September/October) and the final stability time point was communicated as due in December. Even if you dismiss the question of why this stability request was a surprise, it is very hard to understand why the manufacturing section was not available in January at the latest as the entire submission should have been written and triple checked just waiting for the final stability checkpoint data to be entered into the submission.
Approved manufacturing is needed if we get a very positive BTD response with a confirmatory trial requirement and if that is the case, this Multiple month long delay will be costly for investors and patients.
We need info this week in CMC section as info on that section has been eerily quiet.
From NP:
I will read these questions and answer them if no one asks these questions
Craig: Please make sure you have the list of questions below ready for us to answer in the Q/A session of our call on Thursday
With best regards
Nader
Nader Pourhassan, PhD
Director, President & CEO
CytoDyn Inc. (www.cytodyn.com)
1111 Main Street, Suite 660
Vancouver, Washington 98660
(360)980-8524 Ext. 1 - Work
(360)980-8549 -
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