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Operator: [Operator’s Instructions]. The first comes from the Maury Raycroft lineage of Jefferies.
Maurice Raycroft: Congratulations on the progress. I was going to put one on chikungunya. For example, at the recent ACIP assembly in October, the committee assigned to chikungunya advised the vaccination of adults traveling to epidemic areas. However, they expressed some considerations about the duration of protection of the population in order to detect rare adverse effects. as well as the use of immunogenicity as an endpoint. The post-marketing epidemic review addresses any of these problems. But I wonder if the duration of population protection is also an issue that is being discussed with the FDA before the PDUFA and separately. , will the ongoing outbreak study be sufficient prior to the ACIP vote in February, or will the ACIP need additional breakthroughs or testing before voting?
Thomas Lingelbach: Maury, of course, is a wonderful question. So, first of all, the protection database supports licensing, otherwise we wouldn’t be where we are now. Of course, the program is, or will be permitted, according to the fast-track approval procedure. The process of searching through definition uses a surrogate. So, there’s nothing you can do about immunogenicity data. But, of course, we’re going to prove our appeal in the genuine world as a component of Phase IV. And of course, there are also [indistinguishable] studies or protection follow-ups going to be done once the product is used in, I would say, larger cohorts. And this is all part of the ongoing discussions and procedures with the FDA and, of course, will shape the basis for the intended approval.
The Phase IV Protocol and Conceptual Design Agreement are mandatory for permitting. Therefore, the precise design will also be delivered to the ACIP and as such will also make transparent to the ACIP what they will be expecting and what they can be. looking forward to the next few years in relation to chikungunya VLA1553.
Maurice Raycroft: Got it. So, having the design vetted for the ACIP will be enough for them before they hit the road.
Thomas Lingelbach: That’s what we are, that’s our current hypothesis. Yes.
Maurice Raycroft: Okay. So, is there any other information I can share about interactions with the FDA and the frequency of interactions prior to approval in relation to the outbreak study and potential labeling discussions?I just wanted to check if I was saying anything about it.
I think, of course, I mean, I understand, Maury, you know this business quite well, too. We are unable to comment on ongoing interactions with the company. It’s fair to say that, of course, since we’re now at what I’m telling the team all the time in the last mile of the marathon and we have diverse, high-frequency interactions with the company as we review together to conclude this total procedure on time.
Maurice Raycroft: Compreris. Logique. Et maybe one last query for me. Only for Lyme cohort 2. It looks like the registry is going well there. When you fully enroll the cohort to receive the required starting doses for tick season 1, that cohort?I guess you can give us your perspectives on the timeline on this.
Thomas Lingelbach: Basically, there’s not necessarily a definitive release date for all of this. But I think, as you know, our purpose is for other people to be fully vaccinated and preferably have peak titers, optimized for the peak of tick season. And that gives you a little bit of information, given the timing and the fact that we then see the antibody titers at the highest point around month 7 and that gives you a little bit of a matrix. And since tick season hasn’t peaked yet, there’s also the [indistinguishable] that’s not fair. That gives them a little bit of flexibility about it. I’d say early next year.
Earnings Call TranscriptJoshua DrummNASDAQ:VALNPeter BuhlerQ3 2023Thomas LingelbachYahoo FinanceShow more. . . Show less
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