Jun. 4 at 2:25 AM
$REPL AI give us 60-70% of approval.
My Bottom-Line Interpretation
Before the ASCO survival update, I viewed RP1 as a drug with good efficacy data but a difficult regulatory path.
After seeing:
* 32.9-month median OS,
* 47.8% 3-year survival,
* durable responses,
* no major safety signal,
* and FDA willingness to prioritize a third review,
I think the ASCO data materially strengthen Replimune’s argument.
The question is no longer, “Does RP1 appear active?” Most melanoma experts would likely say yes.
The question is, “Has FDA become willing to accept this evidence package without waiting for the ongoing randomized phase 3 trial?” The ongoing phase 3 study exists precisely to answer the control-arm question.
If I were assigning probabilities today:
* Approval on third review: 60-70%
* Another CRL: 30-40%
