Nader Pourhassan, CytoDyn CEO (Jeff Kravitz/FilmMagic for CytoDyn’s Pro, via Getty Images)
May 17, 2021 04:31 PM EDTUpdated May 21, 03:13 PM
Bioregnum
FDA+

FDA to Cy­to­Dyn: Those 2 Covid tri­als you keep tout­ing both failed on all end­points and your sub­group analy­sis does­n't help. Are we clear now?

As a mat­ter of of­fi­cial pol­i­cy, the FDA doesn’t com­ment about un­ap­proved drugs and the da­ta gath­ered to back them.

As an un­of­fi­cial pol­i­cy, though …

Endpoints Premium

This article is available only to Premium subscribers

Upgrade to Premium for unlimited access and Premium exclusives.

UPGRADE
TRENDING NOW

PTC re­ports Phase 2 ALS fail, sells pri­or­i­ty re­view vouch­er for $150M

FDA is look­ing in­to hema­tol­ogy risks af­ter pa­tients take Blue­bird's Skysona gene ther­a­py

Nor­bert Bischof­berg­er's time as Kro­nos CEO ends as biotech seeks new life

To lead NIH, Trump taps Stan­ford aca­d­e­m­ic and pan­dem­ic re­sponse crit­ic Jay Bhat­tacharya

Ap­plied Ther­a­peu­tic­s' rare dis­ease drug gets a CRL

No­var­tis to cut 139 jobs in NJ as part of com­mer­cial re­fo­cus

A service from the Financial Times