GB, so for the rolling BLA helps cut down on the t
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Posted On: 04/27/2020 10:51:10 AM
GB, so for the rolling BLA helps cut down on the time frame for approval considerably. I would expect decision from FDA 3 to 6 months I would guess, but no later than 6 months ( OCT 2020)
The FDA previously granted both Fast Track designation for leronlimab and rolling review for the Company’s BLA in HIV indication.
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
“The submission of the final two parts of the BLA is a significant milestone for the Company, and initiates its transition from a development-stage company to a commercial organization.
The FDA previously granted both Fast Track designation for leronlimab and rolling review for the Company’s BLA in HIV indication.
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
“The submission of the final two parts of the BLA is a significant milestone for the Company, and initiates its transition from a development-stage company to a commercial organization.
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