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Posted On: 10/27/2020 10:35:58 AM
Post# of 154011
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn (CYDY), commented,
“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.
The MHRA also had questions about CytoDyn’s recent COVID-19 Phase 3 severe-to-critical population interim analysis.
We are very excited with all of the opportunities we are able to explore for leronlimab’s potential indication in the U.S. and abroad.
Should CytoDyn (CYDY) receive approval in the U.K. for HIV combination therapy, we will follow up immediately with a label expansion of monotherapy in U.K.”
“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.
The MHRA also had questions about CytoDyn’s recent COVID-19 Phase 3 severe-to-critical population interim analysis.
We are very excited with all of the opportunities we are able to explore for leronlimab’s potential indication in the U.S. and abroad.
Should CytoDyn (CYDY) receive approval in the U.K. for HIV combination therapy, we will follow up immediately with a label expansion of monotherapy in U.K.”
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