Aug. 18 at 7:29 PM
$RDGL If the issues are addressable (e.g., monitoring protocols, manufacturing documentation, animal-to-human translation data), it can still lead to eventual approval without needing a complete restart. FDA would not bother with a punchlist if they thought it was a dead end. The fact they declined with a punchlist and follow-up meeting within ~10 days, means the FDA still sees a viable path forward.
That’s bearish short-term (delay headlines) but bullish medium-term (FDA engagement, not dismissal).
Looking at past examples of radiopharma/gel IDEs that were initially “not approvable” but got approved on second submission Sirtex Medical/IsoRay/Delcath Systems/BTG - Therasphere
Pattern Across These Cases
FDA almost always issues a punchlist in cycle 1 for radiopharmaceuticals, gels, or brachytherapy-like devices.
Resubmission is usually within ~3 months after sponsor/fda meeting.
IMHO--Ultimate approval rate is high once deficiencies are addressed.
