That was quick. Just came out, 12:49am, October 2
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Posted On: 10/27/2020 1:37:54 AM
That was quick.
Just came out, 12:49am, October 27
Seeking Alpha
"Cytodyn to file marketing application for leronlimab as combination therapy for HIV in U.K.
The Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government has cleared CytoDyn (OTCQB:CYDY) to file its Biologics License Application (BLA) for leronlimab as a combination therapy for multi-drug resistance HIV patients.
The clearance included a treatment regimen of one injection per week of 350 mg of leronlimab, as contrasted to the dosage of two consecutive 175 mg injections per week used in the U.S. Phase 3 trial.
CytoDyn and the MHRA discussed in detail the primary components of BLA filing: non-clinical, clinical and manufacturing.
In connection with the manufacturing section, the Company confirmed it had the necessary one-year of stability data for a 350 mg dose of leronlimab for patients in need of this treatment.
“We are very pleased with the MHRA’s decision to clear our BLA for filing and our team is finalizing the remaining details to ensure a complete filing very soon. We hope to receive notice of acceptance within two weeks of our filing," commented Nader Pourhassan, Ph.D., President and CEO.
CytoDyn is currently conducting its Phase 2b/3 COVID-19 trial for patients with severe-to-critical indications in numerous hospitals and clinics across the U.S.
https://seekingalpha.com/news/3626162-cytodyn...ent=link-3
Just came out, 12:49am, October 27
Seeking Alpha
"Cytodyn to file marketing application for leronlimab as combination therapy for HIV in U.K.
The Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government has cleared CytoDyn (OTCQB:CYDY) to file its Biologics License Application (BLA) for leronlimab as a combination therapy for multi-drug resistance HIV patients.
The clearance included a treatment regimen of one injection per week of 350 mg of leronlimab, as contrasted to the dosage of two consecutive 175 mg injections per week used in the U.S. Phase 3 trial.
CytoDyn and the MHRA discussed in detail the primary components of BLA filing: non-clinical, clinical and manufacturing.
In connection with the manufacturing section, the Company confirmed it had the necessary one-year of stability data for a 350 mg dose of leronlimab for patients in need of this treatment.
“We are very pleased with the MHRA’s decision to clear our BLA for filing and our team is finalizing the remaining details to ensure a complete filing very soon. We hope to receive notice of acceptance within two weeks of our filing," commented Nader Pourhassan, Ph.D., President and CEO.
CytoDyn is currently conducting its Phase 2b/3 COVID-19 trial for patients with severe-to-critical indications in numerous hospitals and clinics across the U.S.
https://seekingalpha.com/news/3626162-cytodyn...ent=link-3
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