May. 28 at 12:09 PM
$OTLK $BTM $MSTR $NVDA
https://ir.outlooktherapeutics.com/news-releases/news-release-details/outlook-therapeutics-wins-appeal-following-formal-dispute/
The two key points that completely changed regulatory-wise:
Before: “confirmatory evidence of efficacy” was not sufficient.
Now: “substantial evidence of effectiveness has been established.” And: Instead of fears about a completely new large study, the FDA is now discussing a potential Class 1 resubmission with a possible decision within ~60 days.
Meanwhile, Nasdaq’s median analyst price target is still around
$4–6 while OTLK trades below
$1 despite EU/UK approvals and a potential U.S. approval in a multi-billion dollar market.
The race has just begun! Go!