Investors Hangout Stock Message Boards Logo
  • Home
  • Mailbox
  • Boards
  • Favorites
  • Whats Hot!
  • Login - Join Now!
CytoDyn Inc CYDY
(Total Views: 531)
Posted On: 05/08/2020 1:28:20 PM
Post# of 153984
Posted By: ohm20
Re: craigakess #32917
Here is exactly what was said. It was completed and submitted and the FDA didn't consider it complete because they wanted a different setup for the data sets.

That the FDA changed it's mind makes no difference to it originally being completed and submitted.

April 27th
Quote:
CytoDyn Submits Completed Biologics License Application (BLA) to the FDA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients


May 4th
Quote:
We would like to provide an update that the Biologics License Application (BLA) for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients will be considered completed after the clinical datasets are submitted on May 11, 2020. The clinical datasets are updated to address FDA comments for mock datasets from March 12 and March 20, 2020. After the BLA submission is considered completed, FDA makes a filing decision and sets a PDUFA goal date.














(1)
(0)









  • New Post - Investors HangoutNew Post

  • Public Reply - Investors HangoutPublic Reply

  • Private Reply - Investors HangoutPrivate Reply

  • Board - Investors HangoutBoard

  • More - Investors HangoutMore

  • Keep Post - Investors HangoutKeep Post
  • Report Post - Investors HangoutReport Post
  • Home - Investors HangoutHome
  • Mailbox - Investors HangoutMailbox
  • Boards - Investors HangoutBoards
  • Favorites - Investors HangoutFavorites
  • Whats Hot! - Investors HangoutWhats Hot!
  • Settings - Investors HangoutSettings
  • Login - Investors HangoutLogin
  • Live Site - Investors HangoutLive Site