RE: Academy .23 Feb 2026 09:45
Francis 16:33
I think you can have two kinds of conversations with the regulators. You can have a kind of conversation where they’re saying, “Oh, you haven’t done this,” or “You haven’t done that,” and you can have the kind of conversation where they really want you to succeed.
And that’s what they have—kind of two roles. One is to stop rubbish stuff coming through, and the other is to facilitate good stuff coming through. And I really feel that we were in that second one. They were really helpful—“If you did this, this would be a good idea wouldn’t it,” and that kind of thing. Rather than “Why did you not do that?” or “You need to do this,” it was much more encouraging, in the right direction, to help us get through. They want this to succeed. That’s really what came across from the comments.
Christina Coughlin 17:22
That was really the sense across, I would say, our entire team—not just Francis and myself, but our entire team. It felt like they were almost helping us.
Francis
Pushing on that door.
Christina Coughlin 17:36
Pushing us, yes, through that open door.
So we’ve also talked a little bit about how the IND clearance really de-risks the programme tremendously. In that IND review, as we talked about, there were four key aspects: the pharmacology, the toxicology, the GMP manufacturing and the CMC, and then the clinical trial. And so our team was working on all four of those.
Well, when you look at the regulators then, each of these has a team that is assessing it, so it’s not just one person—it’s a large team.
Francis 18:23
It’s a little bit like peer review. When you get a publication out there, typically you read something in a high-quality journal and you believe it not just because they wrote it, but because to get to that point, people who know about this stuff have read it, asked questions, and checked things.
What we’re doing here is essentially, in order to get a drug through the FDA, you are talking to the experts and convincing them that yes, it is safe, yes, it has a chance of doing some good for the patients. And as we were saying, they’ve seen what we presented to them, and are really excited about it and want it to move forward. So that’s why we think it’s been de-risked—because the experts have looked at it and said, “This is a good thing.”
Sign In
Follow the stocks
