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CytoDyn to meet with UK regulators to discuss Fast-Track approval for leronlimab, schedules sitdown with FDA

CytoDyn will submit its current Phase 3 CD12 study for severe-to-critical COVID-19 patients in the UK to the Urgent Public Health Research scheme to receive possible financial support

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CytoDyn was informed by the US Food and Drug Administration (FDA) that the agency has scheduled a Type A meeting for September 8

CytoDyn Inc (OTCQB:CYDY) has been granted a meeting with the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) to discuss the its request for fast track approval of leronlimab to treat mild-to-moderate coronavirus (COVID-19) patients, the company announced Wednesday. 

At the agency’s suggestion, CytoDyn will submit its current Phase 3 CD12 study for severe-to-critical COVID-19 patients in the UK to the Urgent Public Health (UPH) research scheme to receive possible financial support from the trial sites and the government, if the UPH deems the company’s CD12 trial an urgent health issue.

“We are very encouraged by the MHRA’s considering fast track approval of leronlimab and granting us a meeting,” CEO Nader Pourhassan said in a statement. “In this meeting, CytoDyn will present a summary of its BLA for HIV in conjunction with our request for fast track approval for COVID-19 indication. We are also grateful to the MHRA for advising us about potential financial support from the sites and UK government for our CD12 study currently in process.”

READ: CytoDyn forms Scientific Advisory Board, including leading HIV, NASH, Oncology, and Rheumatological clinical experts and researchers

Additionally, CytoDyn was informed by the US Food and Drug Administration (FDA) that the agency has scheduled a Type A meeting for September 8. A Type A meeting is immediately necessary for a stalled drug development to proceed, according to agency documents.

The company received answers from the FDA to questions regarding its Biologics License Application (BLA) for leronlimab as a combination therapy for highly treatment-experienced HIV patients. The FDA clarified the items it needed primarily related to dosage levels, the company said.

“We also look forward to meeting with the FDA to help expedite the resubmission of our BLA, as well as learning whether we receive Emergency Use Approval for leronlimab for COVID-19 or, alternatively, are required to proceed with a Phase 3 trial,” Pourhassan said. “Regardless, we are working diligently to ensure the availability of leronlimab worldwide to provide a potential benefit for patients infected with this terrible disease.”

Contact Andrew Kessel at [email protected]

Follow him on Twitter @andrew_kessel

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Price: 2.46 USD

OTCQB:CYDY
Market: OTCQB
Market Cap: $1.4 billion
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