(Total Views: 614)
Posted On: 06/25/2020 2:34:25 AM
Post# of 149015
Re: Borel Fields #39076
The company has indicated in a PR that May 11, where the BLA was completed, will be considered as the filing date, at least that's what I infer from the following text:
"...May 11, 2020, it submitted all remaining parts of the Company’s Biologics License Application (“BLA”) for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients to the U.S. Food and Drug Administration (“FDA”). Pursuant to FDA guidelines, CytoDyn informed the FDA it had submitted a complete BLA for rolling review.
As a next step, the FDA will start reviewing the BLA for completeness and will make a filing decision."
"...May 11, 2020, it submitted all remaining parts of the Company’s Biologics License Application (“BLA”) for leronlimab as a combination therapy with HAART for highly treatment experienced HIV patients to the U.S. Food and Drug Administration (“FDA”). Pursuant to FDA guidelines, CytoDyn informed the FDA it had submitted a complete BLA for rolling review.
As a next step, the FDA will start reviewing the BLA for completeness and will make a filing decision."
(1)
(0)Scroll down for more posts ▼
