FDA slams for­mer Cy­to­Dyn CEO's mis­lead­ing in­ter­view in new warn­ing let­ter

The FDA’s Of­fice of Pre­scrip­tion Drug Pro­mo­tion re­cent­ly sent an­oth­er harsh warn­ing to tiny biotech com­pa­ny Cy­to­Dyn for a pro­mo video in which the com­pa­ny’s re­cent­ly boot­ed CEO makes un­sub­stan­ti­at­ed claims about its unau­tho­rized Covid-19 treat­ment known as leron­limab.

In leron­limab’s case, the FDA al­ready is­sued a rare pub­lic re­buke of the firm’s clin­i­cal stud­ies and pro­mo cam­paigns last May, ex­plain­ing the 2 tri­als failed on all end­points. The com­pa­ny is al­so fac­ing DOJ and SEC in­ves­ti­ga­tions for its pro­mo­tion­al prac­tices.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER