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Posted On: 12/01/2021 8:06:35 AM
Post# of 148884
CytoDyn Submits CMC (Manufacturing) Section of HIV BLA to FDA Under Previously Authorized Rolling Review; Last (Clinical) Section Will Complete Full BLA Submission
December 1, 2021 - 8:00 am
CMC section is of great importance to our other potential approvals, including potential EUA for COVID-19 and Breakthrough Designation Therapy in Cancer
FDA may initiate review of this BLA under previous rolling review granted to CytoDyn
VANCOUVER, Wash.CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it has completed submission of all the major sections of CMC modules to FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week. CMC is a critical part of CytoDyn’s Biologics License Application (“BLA”) for HIV. This submission was made under rolling review consistent with guidance from the U.S. Food and Drug Administration (“FDA”). Only the clinical section remains to be submitted.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are pleased to get close to completion of our HIV full BLA submission. We have only one more section (from the main three sections) to submit. With our resubmission of the non-clinical and CMC sections behind us, we are very excited to have our HIV and other activities back on track after the difficulties we experienced with our previous CRO. Our CD15, Long-Hauler’s trial for COVID-19, was submitted for peer review yesterday, and we are also very close to submitting our manuscript of HIV CD02, Phase 3, data to a peer reviewed journal. We are extremely excited about both submissions. Also, in light of recent news about multi-drug resistance (MDR) HIV patients having problems with durable viral suppression, we are working on making a request to the FDA for approval of expanded use of leronlimab in the HIV, MDR population. We are grateful to CytoDyn’s new BLA team, under the supervision of Dr. Nitya Ray and his team, and previously Dr. Chris Recknor, for their excellent work in helping us to reach these milestones. We believe this will lead to a very successful 2022 for CytoDyn.”
Nitya Ray, Ph.D., CytoDyn’s Chief Operating and Technology Officer, commented, “We are grateful for the excellent job that the CytoDyn’s dynamic CMC team has done working relentlessly alongside CytoDyn’s consultants and Dunn Regulatory Associates. In this submission we have included data of leronlimab manufacturing at Samsung Biologics. We are also grateful for the invaluable support we have received from Samsung’s Development, Manufacturing and Regulatory groups.”
December 1, 2021 - 8:00 am
CMC section is of great importance to our other potential approvals, including potential EUA for COVID-19 and Breakthrough Designation Therapy in Cancer
FDA may initiate review of this BLA under previous rolling review granted to CytoDyn
VANCOUVER, Wash.CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it has completed submission of all the major sections of CMC modules to FDA, some remaining supporting documentation will be submitted under Regional Information before the end of this week. CMC is a critical part of CytoDyn’s Biologics License Application (“BLA”) for HIV. This submission was made under rolling review consistent with guidance from the U.S. Food and Drug Administration (“FDA”). Only the clinical section remains to be submitted.
Nader Pourhassan, Ph.D., CytoDyn’s President and Chief Executive Officer, commented, “We are pleased to get close to completion of our HIV full BLA submission. We have only one more section (from the main three sections) to submit. With our resubmission of the non-clinical and CMC sections behind us, we are very excited to have our HIV and other activities back on track after the difficulties we experienced with our previous CRO. Our CD15, Long-Hauler’s trial for COVID-19, was submitted for peer review yesterday, and we are also very close to submitting our manuscript of HIV CD02, Phase 3, data to a peer reviewed journal. We are extremely excited about both submissions. Also, in light of recent news about multi-drug resistance (MDR) HIV patients having problems with durable viral suppression, we are working on making a request to the FDA for approval of expanded use of leronlimab in the HIV, MDR population. We are grateful to CytoDyn’s new BLA team, under the supervision of Dr. Nitya Ray and his team, and previously Dr. Chris Recknor, for their excellent work in helping us to reach these milestones. We believe this will lead to a very successful 2022 for CytoDyn.”
Nitya Ray, Ph.D., CytoDyn’s Chief Operating and Technology Officer, commented, “We are grateful for the excellent job that the CytoDyn’s dynamic CMC team has done working relentlessly alongside CytoDyn’s consultants and Dunn Regulatory Associates. In this submission we have included data of leronlimab manufacturing at Samsung Biologics. We are also grateful for the invaluable support we have received from Samsung’s Development, Manufacturing and Regulatory groups.”
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