(Total Views: 152)
Posted On: 03/04/2019 7:31:31 PM
Post# of 154809
Yeah, so many new words. In the PR, they say now ‘initiate a registration-directed study’ in mono.
This was in the PR.
The Company plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biological License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and, plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension.
The rolling submission vs rolling review issue I was looking up, confusion seems to come from the FDA. I believe fast track used to say rolling submission and priority review and BTD said rolling review looking up old caches, which is now deleted. But I’ve seen other PR says rolling submission granted. I believe NP kept trying for BTD to get the rolling review.
This was in the PR.
The Company plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biological License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients and, plans to initiate a registration-directed study of leronlimab monotherapy indication, which if successful, could support a label extension.
The rolling submission vs rolling review issue I was looking up, confusion seems to come from the FDA. I believe fast track used to say rolling submission and priority review and BTD said rolling review looking up old caches, which is now deleted. But I’ve seen other PR says rolling submission granted. I believe NP kept trying for BTD to get the rolling review.
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