The panel was debating Vertex's drug for IgA nephropathy. He steps back to the competitive picture: Vertex enters a crowded market third, with less data.
…I feel like, to be honest, as an analyst covering it, I feel like it's a little bit unbeddable to sort of guess how this plays out. And my gut is that they're not going to get the monitoring requirement, but I really don't know. I mean, like, I don't think the FDA, look, and I mean, again, it's,
…hearing from ASN, but like nephrology, like they're aware of this. Like, no one's like, oh, this lowers IgGs. Oh, my God. Like, I never knew it up until this protocol came out, right? Like, they know that this is going to take some more attention in terms of managing these patients down the road.
I mean, I think you can also, I mean, you had to account for the fact. And Vertex, you know, has been asked about the label and what they think. They've been both at the ASN meeting and then on the earnings call, Restama has been very clear that they feel like they're going to get essentially the same label as everyone else is going to get. They're not going to have this patient monitoring. So, you know, I kind of tend to believe that it would be, I mean, they clearly know what's going on behind the scenes. So I don't think they would be as aggressive in the way that they've been saying this, even though they don't want to answer that question that keeps asking. I mean, the other thing, just stepping back, is that what I find fascinating about all this is just that this is going to be, you know, the kind of the first time since hepatitis C that Vertex has to compete in a market. You know, they obviously don't compete now with CF. And well, I mean, yeah, well, okay. I mean, yeah, I mean, if you want to say pain, and yet, how miserably have they done with pain? I mean, that's been a total disaster from a commercial perspective, as has Caschevi and Sickle Sale. I mean, that's like a black hole…
I would just also add, I mean, I don't think it's a, I don't think it's a small difference that Vertex is not going to have EGFR decline data outcomes data for like two years, right? So they're going to get accelerated approval while both Hatsuka and Vera get full approval and the full approvals…
Right. So we got, you know, we're getting the first indication of Razon Q sales for what would amount to about five weeks of sales, given the late August approval. And, you know, there was a lot of speculation, a lot of expectations. Obviously, this drug is providing great benefit to pancreatic…
Yeah, I mean, sort of, sort of, sort of very shocking. And obviously, like, there's a big debate on sort of valuation. This is a very big market cap for a single drug launch. But, you know, the data's been really great. And by all estimates, this was like way above where expectations were. So, so…
