Oct. 3 at 7:38 PM
$NUVB
Our competitor at NUVL had a chat with UBS conference Yesterday and they said they had completely final rolling submission to FDA b4 the Fed shut down and the expectation sounds high.
For anybody who cares about the timelines of FDA rolling submission and its marketing impacts to Ibtrozi, you can read it below.
FDA will decide if accept its submission within 60-day then 6 or 10 months review time for PDUFA date. So If everything goes right for NUVL, it’s about May 2026 the earliest or Sept latest for FDA approval.
As I stressed b4 that if NUVL gets bad luck during its rolling submission then seriously we need to switch spot with NUVL
$6.1 B MC as of today or at least NUVB shall get to
$3-3.5 B around
$9-10 by mid of 2026. Analysts will be forced to make adjustments since many of them covering both NUVB & NUVL and none of them laid out the facts why there’s
$5 B MC difference in valuations between the 2 same class companies.
