Investors Hangout Stock Message Boards Logo
  • Mailbox
  • Favorites
  • Boards
    • The Hangout
    • NASDAQ
    • NYSE
    • OTC Markets
    • All Boards
  • Whats Hot!
    • Recent Activity
    • Most Viewed Boards
    • Most Viewed Posts
    • Most Posted
    • Most Followed
    • Top Boards
    • Newest Boards
    • Newest Members
  • Blog
    • Recent Blog Posts
    • Recently Updated
    • News
    • Stocks
    • Crypto
    • Investing
    • Business
    • Markets
    • Economy
    • Real Estate
    • Personal Finance
  • Market Movers
  • Interactive Charts
  • Login - Join Now FREE!
  1. Home ›
  2. Stock Message Boards ›
  3. Stock Boards ›
  4. Vg Total Stock Market ETF (VTI) Message Board

FDA Memo CRO Failed to Provide DSMB Oversight

Message Board Public Reply | Private Reply | Keep | Replies (0)                   Post New Msg
Edit Msg () | Previous | Next


Post# of 235
(Total Views: 98)
Posted On: 07/05/2025 8:16:34 AM
Avatar
Posted By: Riztheinvestor
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)


(1)
(0)




Vg Total Stock Market ETF (VTI) Stock Research Links


  1.  
  2.  


  3.  
  4.  
  5.  


Federal Whistleblower
SEC Submission HL-1412396
DOJ Ref #20250705-0001




Investors Hangout

Home

Mailbox

Message Boards

Favorites

Whats Hot

Blog

Settings

Privacy Policy

Terms and Conditions

Disclaimer

Contact Us

Whats Hot

Recent Activity

Most Viewed Boards

Most Viewed Posts

Most Posted Boards

Most Followed

Top Boards

Newest Boards

Newest Members

Investors Hangout Message Boards

Welcome To Investors Hangout

Stock Message Boards

American Stock Exchange (AMEX)

NASDAQ Stock Exchange (NASDAQ)

New York Stock Exchange (NYSE)

Penny Stocks - (OTC)

User Boards

The Hangout

Private

Global Markets

Australian Securities Exchange (ASX)

Euronext Amsterdam (AMS)

Euronext Brussels (BRU)

Euronext Lisbon (LIS)

Euronext Paris (PAR)

Foreign Exchange (FOREX)

Hong Kong Stock Exchange (HKEX)

London Stock Exchange (LSE)

Milan Stock Exchange (MLSE)

New Zealand Exchange (NZX)

Singapore Stock Exchange (SGX)

Toronto Stock Exchange (TSX)

Contact Investors Hangout

Email Us

Follow Investors Hangout

Twitter

YouTube

Facebook

Market Data powered by QuoteMedia. Copyright © 2025. Data delayed 15 minutes unless otherwise indicated (view delay times for all exchanges).
Analyst Ratings & Earnings by Zacks. RT=Real-Time, EOD=End of Day, PD=Previous Day. Terms of Use.

© 2025 Copyright Investors Hangout, LLC All Rights Reserved.

Privacy Policy |Do Not Sell My Information | Terms & Conditions | Disclaimer | Help | Contact Us