Pink Sheet

US FDA Rebukes Another Sponsor For Touting Investigational Product Based On Subgroup Efficacy

18 May 2021

CytoDyn’s COVID-19 candidate leronlimab joins BrainStorm’s ALS therapy in being taken to task as FDA has become more willing to publicly counter investigational drug data announcements it considers to be misleading.

Rosy picture — The FDA has issues with CytoDyn's rosy picture of leronlimab efficacy in treating COVID. • Source: Alamy

For the second time in less than three months, the US Food and Drug Administration has taken the extraordinary step of publicly refuting a sponsor’s upbeat claims about the efficacy of an investigational drug.

On 17 May, the agency announced that two trials of CytoDyn, Inc.’s leronlimab “do not support the...