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CytoDyn’s Promotion Of Investigational Drug Leronlimab Once Again Rebuked By US FDA

 
• By Brenda Sandburg

OPDP warning letter objects to video interview in which CytoDyn's then CEO touts use of the investigational drug for COVID-19. The exec says he is ‘making up numbers’ but if the pattern continues there will be ‘the most fantastic results’ anybody could ever imagine.

Monoclonal antibody
CytoDyn video promotion for its investigational COVID-19 treatment draws FDA warning letter • Source: Alamy

For the second time in a year, the US Food and Drug Administration has reprimanded CytoDyn, Inc. for making claims about the efficacy of its investigational drug leronlimab for treatment of COVID-19. The agency went further this time, with the Office of Prescription Drug Promotion issuing a warning letter to the company demanding that it submit a plan to disseminate a corrective communication.

In a 11 February letter, OPDP objected to a video interview in which then CytoDyn president and CEO Nader Pourhassan discusses the safety and efficacy of leronlimab. The interview was conducted by Proactive Media on 22 September 2021 and was available via hyperlink on CytoDyn’s corporate website. The

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UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 
• By Anabel Costa-Ferreira

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