(Total Views: 536)
Posted On: 05/13/2020 10:01:31 AM
Post# of 155808
LOL . I know we have been over this . But I feel like , with the backlash of short and distort the company continues to use complete to offset short rhetoric . Although in their own press release they confirm they know absolutely what complete means . Per press releases from them in their own wording . Below when fully complete you get a pdufa date . Their words
The BLA will not be considered completed until the Company submits to the FDA clinical datasets required to address FDA comments it received in March 2020, as described in the Company’s press releases on May 4 and May 6, 2020. CytoDyn expects to submit these clinical datasets on May 11, 2020.
After the BLA submission is deemed completed, FDA makes a filing decision and sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA and the Company plans to request a priority review for the BLA. A priority review
The BLA will not be considered completed until the Company submits to the FDA clinical datasets required to address FDA comments it received in March 2020, as described in the Company’s press releases on May 4 and May 6, 2020. CytoDyn expects to submit these clinical datasets on May 11, 2020.
After the BLA submission is deemed completed, FDA makes a filing decision and sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA and the Company plans to request a priority review for the BLA. A priority review
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