With that, we’ll now ask Pharis and Virginie to join me for the Q&A. And operator if you could open up the lines for questions, that’d be great.
Operator: We will now begin the question-and-answer session. [Operator Instructions] Jon Wolleben with Citizens JMP. Please go ahead.
Jon Wolleben: Hey, good afternoon and thanks for taking the questions. First, I was hoping you can give a little bit more color on this EU directive. And then also can you comment how many of the 600 expected patients in VITESSE you’ve already enrolled to-date?
Daniel Tassé: I’ll have Pharis answer the question on the directive.
Pharis Mohideen: Yeah, Jon, it’s Pharis. So this EU directive is a little bit different from how things were done in the past. So you have to submit your dossier, your protocol and the countries that you’ve selected in Europe all are banded together essentially as one country. So in the past you could go one off to Germany, Italy, Spain, whichever countries you want to, in this case they’re all bundled into one. So if any country has any objection, it has to go all the way to be resolved and that process can continue almost indefinitely. And the big difference here is if one country protests and has an issue all of the countries are stuck, they can’t participate and you can’t pull out and won off, bill separately to all the different countries.
So it is a bit different and I think the challenge here was we were one of the first Phase 2 protocols that went through. And so the system wasn’t quite worked out, and I think there was a just a glitch here and there. And as these new things come through, they’re not always well oiled. So that’s the nature of the difference in the directive now versus how it was in the past.
Jon Wolleben: Got it. And can you comment on how many of the expected 600 patients have been enrolled so far?
Pharis Mohideen: We don’t provide that clarity of guidance for competitive reasons here. The study is progressing well against the forecast we had in place assuming that the sales were up and running, we’ve been up and running there as expected. What I can share is we expect that 60 to 90 days would be sufficient to get through the new directive process. It took us closer to — actually took exactly nine months to go through it. And that explains why we are out of abundance of prudence pushing the expectation of last patient screen from a first half of — Q2 of 2024 to Q3 of 2024.
Jon Wolleben: Got it. Okay. And any timing guidance on when COMFORT Toddlers will be starting? And then how do you think about the parallel programs, do you want them to be exactly parallel with BLA submissions in the same time period? Does that make it easier for you or potentially the review division? Or could there be staggering and one coming before the other?
Daniel Tassé: Yeah. So I’ll have Pharis answer the first question on COMFORT Toddlers, and I’ll talk about the benefits of having the two programs being parallel with.
Pharis Mohideen: Yeah. Jon as we’ve always said, we will start our Phase 3 programs when we have FDA feedback, so we’re waiting for the FDA feedback. We’ve done all the preparations we can in terms of the team and [indiscernible] being ready to go once we get that feedback. So we believe it will be a short period turnaround from a financial standpoint. So again and it’s the right thing to do for Phase 3 trials get FDA feedback in alignment before we start to run.
Daniel Tassé: And we’re in communication with them and they may reinforce to us. And we believe from the pace of no response e-mails everything else that they are — this is a top priority. We very much see that, but we’re just waiting for that final sign-off before starting the study out of again common sense prudence.
Jon Wolleben: And then the other question?
Daniel Tassé: Yeah to come back to the benefits of the two doses in parallel, is that your other question?
Jon Wolleben: Yes, yes please.
Daniel Tassé: Look, both markets are use. So I think it was essentially coming down to a rate to commercial potential, rate them even, quite simply. Obviously the program in toddlers is more straightforward is only one study to run. What we have to run with in four to seven year olds. But that was why we were very happy when the agency agreed, that these would be two separate BLAs. Making not one to be junior to the other by being the BLA and the supplemental BLA and thus, whichever one can file first. We will file first and making us as a Commercial matter in different two which one is ready first.
Jon Wolleben: Okay. And then, just to …
Daniel Tassé: That makes sense?
Jon Wolleben: Yeah. Last — last one for me Daniel. I know you touched on this, but product approval. Can you discuss how allergist you speak to or thinking about Viaskin Peanut to use versus older used EPITOPE. Do you think there’s an overlap between the patients that may like both? Or do you think these are going to be separate addressable markets based on the product profile? And I’ll jump back in the queue. Thanks.
Daniel Tassé: Yeah. I’ll have Pharis to give you more detail, because the stuff, we’ve also talked a bunch about or just acquired. I know there’s very little overlap between the two markets which is why, as all their approval is important here by offering options. And the populations are pretty significantly different. So Pharis will share the, which is done from it.
