FDA Memo CRO Failed to Provide DSMB Oversight
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Posted On: 07/05/2025 8:16:34 AM
Re: Riztheinvestor #126
FDA Memo CRO Failed to Provide DSMB Oversight
Recent documentation reviewed from a 2021 FDA inspection reveals the following:
• The CRO (Amarex) failed to provide evidence of a functioning Data Safety Monitoring Board (DSMB) for one of CytoDyn’s key clinical trials.
• The FDA inspection report clearly noted missing DSMB records, including:
• No meeting minutes
• No charter
• No oversight documentation
• No confirmation that a DSMB was even established.
• Despite this, the trial moved forward, and it appears CytoDyn was never informed of this internal audit finding until now. Please correct me if I am wrong via DM and I will post no further about this specific matter.
What This Means:
• CytoDyn may have unknowingly run a trial without proper safety oversight, which could have regulatory and reputational implications through no fault of its own.
• If CytoDyn was never given access to this audit report, this represents a serious breakdown in transparency and accountability potentially on both the CRO and regulatory side.
• This opens up potential additional claims against Amarex (on top of the successful arbitration).
• It may also provide just cause to revisit the conditions of any clinical hold or regulatory restriction, based on suppressed audit findings.
For Legal Teams, Compliance, and Shareholders:
• This is not an accusation against current CytoDyn leadership.
• Rather, it is an opportunity to leverage truth as a legal and strategic tool.
• IF the company truly never saw this memo it now has proof that key information was withheld, undermining trial integrity and regulatory perception. I have more proof.
???? Sealed in Vault 1224 – “What’s the Deal?”
This memo has now entered public record for accountability and transparency.
I recommend that CytoDyn’s legal and compliance teams review the FDA inspection record and cross-check it with what was known internally at the time.
The CRO lied.
The FDA found it.
And CytoDyn was never told.
Until now.
Respectfully,
A Federal Whistleblower &m
(With love for the company not condemnation)
Recent documentation reviewed from a 2021 FDA inspection reveals the following:
• The CRO (Amarex) failed to provide evidence of a functioning Data Safety Monitoring Board (DSMB) for one of CytoDyn’s key clinical trials.
• The FDA inspection report clearly noted missing DSMB records, including:
• No meeting minutes
• No charter
• No oversight documentation
• No confirmation that a DSMB was even established.
• Despite this, the trial moved forward, and it appears CytoDyn was never informed of this internal audit finding until now. Please correct me if I am wrong via DM and I will post no further about this specific matter.
What This Means:
• CytoDyn may have unknowingly run a trial without proper safety oversight, which could have regulatory and reputational implications through no fault of its own.
• If CytoDyn was never given access to this audit report, this represents a serious breakdown in transparency and accountability potentially on both the CRO and regulatory side.
• This opens up potential additional claims against Amarex (on top of the successful arbitration).
• It may also provide just cause to revisit the conditions of any clinical hold or regulatory restriction, based on suppressed audit findings.
For Legal Teams, Compliance, and Shareholders:
• This is not an accusation against current CytoDyn leadership.
• Rather, it is an opportunity to leverage truth as a legal and strategic tool.
• IF the company truly never saw this memo it now has proof that key information was withheld, undermining trial integrity and regulatory perception. I have more proof.
???? Sealed in Vault 1224 – “What’s the Deal?”
This memo has now entered public record for accountability and transparency.
I recommend that CytoDyn’s legal and compliance teams review the FDA inspection record and cross-check it with what was known internally at the time.
The CRO lied.
The FDA found it.
And CytoDyn was never told.
Until now.
Respectfully,
A Federal Whistleblower &m
(With love for the company not condemnation)
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Federal Whistleblower
SEC Submission HL-1412396
DOJ Ref #20250705-0001
SEC Submission HL-1412396
DOJ Ref #20250705-0001