Replimune Group FDA announcement

Our next question comes from Lee Wasek with Cantor Fitzgerald.

Hi. Hey, guys. I wanted to add my congrats as well Maybe just first question on the manufacturing side. Just wondering if you have enough drug on hand right now for the launch. And when will you be able to ship ship IP one to the patients? And then second, on the confirmatory study. Just wondering if you can share the enrollment status and when you might be able to share into an OS analysis. And is there. FDA requirement in terms of the timeline?

Yeah. Thank you. I think there were three questions there. So I'll take the first couple and then I'll add the confirmatory study over to Kostas. So in terms of how much drug supply we have, we have about a year of inventory on hand. So I think we're in good shape there. We expect to ship Rtp1 in approximately 60 days from now. And the team is working very hard to ensure that we can deliver on that. And in terms of the confirmatory trial and timelines, in terms of accelerated approval, current enrollment, I will hand over to Kostas.

Sure. Yes. So the confirmatory study, ignite three is ongoing with an overall survival endpoint event driven study. We expect the enrollment to complete around 2030. In terms of recruitment, we have recruited about one third of the study already. And we're moving forward. Opening the ex-US sites.

Just to clarify that data, in 2030.

Correct. As a reminder, if you'd like to ask a question at this time, that's star one one.

Our next question comes from Dana Grabosch with Leerink Partners.

One of the kind of criteria we looked at were there were a number of criteria we looked at for those, as I mentioned, you know, do they have integrated interventional radiology? Do they have intratumoral experience? Are they clinical trial sites. And yes, one of the overlaps is and there's a very significant overlap with and tag treatment centers as you can. Their initial focus is in these hospital based and academic accounts. So I think there's probably an 8,590% overlap with with MTV treatment centers. And. Then secondly, sorry, your question was on.

Society of Interventional Radiology and Sio, the Society of Interventional Oncology. So they were very excited and really looking forward to having RP one available. Obviously, we will need to sort of ramp up some of those activities, but I would say in terms of some of the key oncology interventional radiologists and are the key large academic sites, I think the awareness is very good, but that's certainly something we'll be using the sort of next few months to make sure that we are ensure that they have what they need, they're aware and that we're hitting the right people.

Our next question comes from Evan Seigerman with BMO Capital Markets.

Read over to the i3 study. Firstly, the primary endpoint in i3 is overall survival, which really has, you know, the response criteria and assessment really has no impact on whether the patient ultimately lives longer or not. So I don't think there's a lot of read through on that. I don't think this label and sort of what the discussion was at the Adcom really has much impact on where we expect commercial uptake to be. As I mentioned, the and as you heard from physicians, I think they're very excited about having a different option that treats this really hard to treat patient population. And given the safety and efficacy profile and the fact that we can treat a broad range of patients, I think that's going to trump any sort of conversations or downside from the Adcom.