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. CytoDyn Inc (CYDY) Message Board

But the third party auditors were not done working

Message Board Public Reply | Private Reply | Keep | Replies (2)                   Post New Msg
Edit Msg () | Previous | Next


Post# of 155000
(Total Views: 702)
Posted On: 11/23/2023 1:29:20 AM
Posted By: ohm20
Re: MLAB #139240
Quote:
But the third party auditors were not done working on all of the Amarex crap. Long story short, the auditors were able to validate the RAW DATA. This is the data that is cloected by clinicians that interface with the patients collect and eventually put into the electronic files. The CRO does not do that.



The CRO or pharma company (if directly running the trial) are responsible for validating data. Do you think the FDA accepts un-validated data. Validating tens or hundreds of thousands of points of data across over six hundred patients would have astronomical costs and a very long timeline. Almost certainly the companies hired to review feasibility looked to see if the data existed at the clinics and what the cost of recovery, validation and BLA submittal would be.

Quote:
IMO and other familiar with BLA filings that the majority of the documents and other documents CYDY was working on are for passing a BLA submission audit. We HAVE NO DOUBTS ABOUT THAT. The clinical hold will be lifted and we feel based on experience that a BLA resubmission will happen at a minimum.



Time will tell won't it.

Quote:
The FDA had the UNUSUAL PDUFA-likje panel meeting. The only thing different about that meeting is: it was not public (PDUFA meetings are public) and there was not vote of yes or no...as far as we know.



I'm not sure which meeting you are talking about. If it's a meeting about the BLA submission between the FDA and the Sponsor they're not public. If it's internal FDA meetings to review the final decision on a BLA submission they're not public either. If it's a meeting about the safety hold being lifted or a possible BLA resubmission those are an FDA/Sponor meeting and are also not public.


(11)
(0)




CytoDyn Inc (CYDY) Stock Research Links


  1.  
  2.  


  3.  
  4.  
  5.  






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