Feb. 9 at 7:51 PM
$RGNX
I think people are confused here. A halt so close to an approval date the FDA have to file their decision due to this being the extension of 1 approval cycle.
You longs want an actual mirror play of a clinical hold followed days later by a CRL letter?
$ATRA
Just days before their expected regulatory action, the FDA placed a clinical hold on Atara’s trials. The reason was a manufacturing (GMP) compliance issue at a third-party facility
Because the clinical hold was active and the underlying safety/quality concerns weren't resolved, the FDA issued a CRL on the scheduled decision date.
Like RGNX, the hold at Atara affected multiple programs because they shared the same "risk profile" (in Atara's case, the manufacturing site; in RGNX's case, the AAV vector platform). ATARA dropped over 50% on the CRL.
Once the FDA has used its one-time 3-month extension (which they already did for RGNX’s RGX-121), they must act by the PDUFA date.
