CytoDyn Issues Request for Fast Track with UK’s MHRA While CEO Offers Some Color on Positive Momentum

CytoDyn Issues Request for Fast Track with UK’s MHRA While CEO Offers Some Color on Positive Momentum

CytoDyn recently issued a request to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for Fast Track approval for leronlimab as a treatment for COVID-19. Recently, top-line data from a Phase 2 clinical trial of the investigational product in patients with mild-to-moderate COVID-19 symptoms report “efficacy and safety results.”

Christine Corrado recently interviewed CEO Nader Pourhassan who reports negative chatter despite rigorous randomized controlled studies with statistically significant end points. Specifically the CEO stated, ““Double-blinded clinical trials that are randomized 2:1, like our study, are very challenging to reach significant results as we demonstrated in a small population of a tough [coronavirus] population in which to show efficacy and safety. We are eager to see the capabilities of leronlimab in our Phase 3 clinical trial for the severe-to-critical patient population. Our enrollment is now at 182 and we are very optimistic we will reach 195 by the end of August”, the CEO added.

Regulators Moving?

Moreover, the company reports that UK’s MHRA authorized the company to enroll for its ongoing Phase 3 COVID-19 trail for severe-to-critical patients in Great Britain. Moreover, the company issued a press release that the U.S. Food and Drug Administration (FDA) will keep communications moving in respect of timelines for regulatory approvals associated with the process of res-ubmitting the Biologics License Application (BLA) for leronlimab as a combination therapy for HIV.

CytoDyn’s leronlimab shows promise targeting COVID-19. In the meantime, Ms. Corrado of Proactive Investor drills into some of the value proposition of CytoDyn. The CEO reports the company has been “under attack” and hence the stock is down but they have a historical amount of cash.

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