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

“The FDA approved the study as a phase 3 interve

Message Board Public Reply | Private Reply | Keep | Replies (1)                   Post New Msg
Edit Msg () | Previous | Next


Post# of 155577
(Total Views: 570)
Posted On: 03/10/2021 8:58:35 AM
Avatar
Posted By: ClosetInvestor
Re: ohm20 #82517
“The FDA approved the study as a phase 3 interventional and then allowed a BLA to be submitted based on that patient number.”

If your above statement was accurate, combo would’ve been approved years ago. But here we are 3 years later, still waiting on the BLA to be completed. There has been something wrong the entire time (trial size is one of those issues) and that’s why the FDA asked for more data. There’s nearly zero chance of a 47 patient trial getting approval by the FDA for HIV, regardless if its was approved by the FDA, a phase 3, and has a stat sig p value.

The FDA approved CD12 and the 62 patient, stat sig endpoint needs a larger trial. In the case of the combo BLA, the FDA agreed to accept data from the mono trial to make to combo trial data more robust.


(3)
(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