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

RLF-100 Added \"60 Days\" to all endpoints. Why can\'t we?

Message Board Public Reply | Private Reply | Keep | Replies (3)                   Post New Msg
Edit Msg () | Previous | Next


Post# of 153773
(Total Views: 546)
Posted On: 03/07/2021 1:47:38 PM
Posted By: melsdollars
I sent this question to Pourhassan and Kelly, but I would be interested in everyone's take on it. This board has a lot of knowledgeable investors. Thanks.

The FDA has updated its guidelines for therapeutic trials. They are now recognizing that judging mortality benefit at 28 days for critical patients is not an accurate picture due to improvements in standard of care. They are recommending following patients for 60 days. See Page 12: COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry. https://www.fda.gov/media/137926/download

"In a trial in severe and/or critically ill patients, examples of appropriate endpoints could be: All-cause mortality at an appropriate time point (e.g., at least 28 days for hospitalized noncritically ill patients, 60 days for critically ill patients ). "

NeuroRX is trialing RLF-100 (Aviptadil) and completed their trial around the same time we did. After unblinding, the FDA allowed them to modify both their primary endpoint and secondaries to allow for 60 days . Here is their PR about it. https://www.neurorxpharma.com/press-releases/...gh-flow-n/

On February 23, 2021 they updated their trial protocol. As you can see, 28 days became the “interim" and "day 60” was added to a majority of their endpoints . See comparison here: https://clinicaltrials.gov/ct2/history/NCT043...udyPageTop

Rather than start again with new patients, why aren’t we asking the FDA to add 60 days to our endpoints? Wouldn’t all of our data be more meaningful and significant at the 60 day point? This would capture the SOC patients that were severe and ended up critical or relapsing as well. That would give us a much broader picture of Leronlimab’s efficacy. Since we already are accumulating that data, wouldn’t that be better and quicker than starting a new group? Can we ask the FDA to do this?

Can we make our case directly to Woodcock? She has repeatedly said that P value is not as important for the severe/critical patients during a pandemic and that an EUA will not require it.



(9)
(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