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Posted On: 04/20/2024 8:30:27 PM
Post# of 156005
* Exhibit K
April 29th, 20200
Suzanne Strayhorn email correspondence:
" Total lies, they did not submit any clinical datasets & they are not expected until May".
"Technically, they should have only submitted module 5 when it was complete with datasets. They still havent given us the DSMB charter. DSMB meeting minutes, (open session & closed session), analysis results/reports presented to DSMB --- we've asked for this multiple times. I'll need to call them today to explain tge clock has not started and they dont have a complete submission. If they think the submission is complete we can send a refusal to file letter today".
Move to that night, her 10 pm email:
EXHIBIT GX152
From: Strayhorn, Suzzane
Sent: 4/29/2020 10:02:36 PM
To: Kazem, Kazempour
Subject: BLA 761144 Remains Incomplete
Importance High
Dear Kazem,
Reference is made to your submission dated April 27th, 2020, to BLA 761144, which included submission of the CMC and an incomplete clinical module to support this BLA application under a rolling review scenario.
Further reference is made to the Cytodyn press release dated April 27, 2020, entitled " Cytodyn Submits Completed" Biologics Liscense Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients", [Press Release]
We have communicated to you multiple occasions as well as provided you with the link to Guidance entitled "Guidance for Industry Expedited Programs for Serious Conditions -- Drugs and Biologics", whereby we clarified that the BLA review clock does not begin until the applicant informs the Agency that a complete BLA was submitted.
Your April 27, 2020, submissions do not constitute a completed BLA as Cytodyn has reported to the public via press release.
The BLA application is not considered complete as you yourself acknowledged in your covering letter with the April 27, 2020, submission --noting that the clinical datasets remain outstanding.
As the regulatory agent on behalf of CytoDyn our expectation is that you have communicated this information to Cytodyn. We ask you to take regulatory responsibility for the misinformation released in the aforementioned Press Release by notifying CytoDyn.
Further we ask that you formally retract submission of the clinical module and resubmit at such time when this module is considered fully complete. We had not made any prior agreements that an incomplete clinical module could be submitted (missing datasets)
Kindly acknowledge receipt of this email communicaton and provide a response to actions you will take as a result of this communication. Please respond no later than noon on Friday, May 1, 2020.
Thank you
Suzzane
Suzzane Strayhorn, MS
Senior Regulatory Project Manager
Antivirals Group
Division of Regulatory Operations for Infectious Disease
Office of Regulatory Operations
Center for Drug Evaluation and Research
US Food and Drug Administration
_________
From: Kazem Kazempour
To: Strayhorn, Suzanne
Date: Thu, 30 Apr 2020 15:22
Dear Suzanne,
This is to let you know that i have received your email and i am talking with the team here and will let Cytodyn know about this email.
Regards,
Kazem
______
Why wasn't his reply @ minimum --- i have or will, frwd this communication to Cytodyn, if he was so confident in his actions.
Not ---- "will let them know".
He sounds like not a care in the world.
April 29th, 20200
Suzanne Strayhorn email correspondence:
" Total lies, they did not submit any clinical datasets & they are not expected until May".
"Technically, they should have only submitted module 5 when it was complete with datasets. They still havent given us the DSMB charter. DSMB meeting minutes, (open session & closed session), analysis results/reports presented to DSMB --- we've asked for this multiple times. I'll need to call them today to explain tge clock has not started and they dont have a complete submission. If they think the submission is complete we can send a refusal to file letter today".
Move to that night, her 10 pm email:
EXHIBIT GX152
From: Strayhorn, Suzzane
Sent: 4/29/2020 10:02:36 PM
To: Kazem, Kazempour
Subject: BLA 761144 Remains Incomplete
Importance High
Dear Kazem,
Reference is made to your submission dated April 27th, 2020, to BLA 761144, which included submission of the CMC and an incomplete clinical module to support this BLA application under a rolling review scenario.
Further reference is made to the Cytodyn press release dated April 27, 2020, entitled " Cytodyn Submits Completed" Biologics Liscense Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients", [Press Release]
We have communicated to you multiple occasions as well as provided you with the link to Guidance entitled "Guidance for Industry Expedited Programs for Serious Conditions -- Drugs and Biologics", whereby we clarified that the BLA review clock does not begin until the applicant informs the Agency that a complete BLA was submitted.
Your April 27, 2020, submissions do not constitute a completed BLA as Cytodyn has reported to the public via press release.
The BLA application is not considered complete as you yourself acknowledged in your covering letter with the April 27, 2020, submission --noting that the clinical datasets remain outstanding.
As the regulatory agent on behalf of CytoDyn our expectation is that you have communicated this information to Cytodyn. We ask you to take regulatory responsibility for the misinformation released in the aforementioned Press Release by notifying CytoDyn.
Further we ask that you formally retract submission of the clinical module and resubmit at such time when this module is considered fully complete. We had not made any prior agreements that an incomplete clinical module could be submitted (missing datasets)
Kindly acknowledge receipt of this email communicaton and provide a response to actions you will take as a result of this communication. Please respond no later than noon on Friday, May 1, 2020.
Thank you
Suzzane
Suzzane Strayhorn, MS
Senior Regulatory Project Manager
Antivirals Group
Division of Regulatory Operations for Infectious Disease
Office of Regulatory Operations
Center for Drug Evaluation and Research
US Food and Drug Administration
_________
From: Kazem Kazempour
To: Strayhorn, Suzanne
Date: Thu, 30 Apr 2020 15:22
Dear Suzanne,
This is to let you know that i have received your email and i am talking with the team here and will let Cytodyn know about this email.
Regards,
Kazem
______
Why wasn't his reply @ minimum --- i have or will, frwd this communication to Cytodyn, if he was so confident in his actions.
Not ---- "will let them know".
He sounds like not a care in the world.
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