A Nifty $415 Million Gain (in an hour) for Shareholders.
Not out of the woods yet..
Short and to the point: We listened to whole meeting and the experts who were negative, were very negative. So it’s a good time to remind everyone that this HAS NOT yet been approved.
You can still watch video here and then act accordingly – whatever that may mean.
ROUGH HISTORY on committee recommendations…from an analyst, not confirmed to any great extent.
Historical correlation between vote margin and approval likelihood. These are aggregated patterns from past FDA advisory committee outcomes (not tied to any single product):
Unanimous or near‑unanimous (≥90% yes)
→ FDA approval likelihood: ~90–95%
Strong majority (70–89% yes)
→ FDA approval likelihood: ~80–90%
Your 10–3 vote = 77% yes → falls squarely in this band.
Narrow majority (55–69% yes)
→ FDA approval likelihood: ~60–70%
Split vote (50–54% yes)
→ FDA approval likelihood: ~50–60%
(FDA sometimes goes against the committee here.)
Negative vote (majority no)
→ FDA approval likelihood: <20%
(Rare exceptions exist, but extremely uncommon.)
These are generalized patterns — not guarantees — but they do reflect how the FDA behaves in practice.
Replimune Group’s melanoma immunotherapy treatment (RP1 combined with nivolumab) is August 2, 2026. The exact hour of the decision is not publicly announced by the FDA, but decisions are typically posted on the official FDA Approvals Database or announced via company press release once finalized. [1, 2, 3]
ARCHIVES
July 30th: Replimune Hurricane Party!
July 14th: Inside the Wild Ride of Replimune (REPL) $10.07. We’re Up And Out, With 360% Gain.
June 8th: We’re Up 360% in Six Weeks. Replimune (REPL). (Detailed report)
April 23rd: Biotech 12 Pack Watch List to be Released.
April 22nd: Adding Replimune to Watch List to 2026 Watch List @ $2.17
No opinion rendered or issued in this and/or any of our posts. We do recommend stocks, just issue “look at what we found” missives for further research.
