Adam Feuerstein 复盘 Replimune 顾问委员会判断分歧，未披露新的 FDA 决定

If I left the impression in my last post that I was trolling @BiotechAutist for his $REPL calls, I was not. Apologies to him if it came off that way.

People who make bold or contrarian predictions are going to be wrong, a lot. That's fine. No one is right all the time, or even close to it.

Replimune is a really interesting case study in how the same set of facts and circumstances can be viewed differently, and shift dramatically.

The highly critical FDA review set an ominous tone for the adcomm and its outcome. We all probably gave Replimune a minimal chance of success. The wild card was going to be the oncologists on the panel, particularly the melanoma experts. What would they say? How would they vote?

Autiste's post during the discussion period of the adcomm caught my eye. He was watching the same panel I was watching, hearing the same comments I was hearing, yet his conclusion / prediction of a negative vote was diametrically different from mine. I was hearing the opposite. To me, the oncologists and melanoma experts sounded supportive of Replimune.

Inside STAT's Slack channel where we were discussing the expert panel discussion while reporting via the live blog, I told my colleagues that Replimune was going to win the vote, mostly because of the supportive comments from Tawbi, the MD Anderson melanoma expert.

I had watched enough of these adcomms to know that one, highly persuasive expert can make a big difference when it comes time to vote - moving the opinions and votes of other participants.

I think that's what happened, and helps explain the 10-3 vote in favor.

Would FDA follow the panel recommendation and approve? Or, dismiss and reject? A tougher call, perhaps, because many of the experts who voted yes did so reluctantly. There was still a lot of uncertainty.

Again, faced with the same set of circumstances, Autiste and I disagreed. He thought FDA would reject again, for the third time. I looked at the situation differently. In STAT's slack channel, we mulled over the same question. I thought there was a 1% chance of an FDA rejection, again, mostly due to the smart, realistic perspectives offered by Tawbi and the other oncologists. They didn't completely dismiss the FDA concerns about the data. What made their arguments so persuasive was that they acknowledged the shortcomings, but still laid out a cogent rationale for why the therapy should be approved. And that was an argument the FDA could not dismiss.

This is why i sincerely appreciated Autiste's posts. I wasn't saying "Haha, you were wrong, loser." I was trying to say, "We watched the same panel and reached totally different conclusions. That's interesting."

Next time, Autiste will be right and I'll be wrong. That's how it goes.