Thomas Lingelbach: I would say the situation with Lyme; it’s in a way unprecedented because of the seasonality of the disease. Under normal circumstances, if you did not have a seasonality to be considered, you lose, for whatever reason, people in your clinical study, and then you just continue recruiting, and the recruitment takes longer. Here, we have of course the situation where you need to recognize the seasonality because otherwise you don’t get the necessary case count in a placebo-controlled (ph) efficacy setting. And as such, there is probably not any precedent to such a specific situation. Now, the discussion with FDA on primary endpoints, secondary endpoints, co-primary endpoints, parallel endpoints; these are discussions that I have been through in my more than 30 years of vaccine development many, many times, and this is certainly nothing unusual, and these are things that need to be based on different statistical modeling.
And this is clearly something that is not new to any regulatory authority. But by the end of the day, it is always a matter of risk, benefit, and judgment. And that’s all I can say at this point in time.
Evan Wang: Got it. And I have a follow-up on chikungunya. Can you expand a little bit more on your travel commercial infrastructure? And in particular, how it compares to that of Bavarian Nordic?
Thomas Lingelbach: So, first of all, we do have own commercial operating entities and organizations in the U.S., in Canada, in the U.K., in France, the Nordics, and Austria. And we are working with Bavarian Nordic under a commercial agreement where, in some of the markets where we have our own infrastructure, we sell Bavarian Nordic products. And in other markets where Bavarian have an infrastructure, they sell our products. As we’ve said previously, of course this whole collaboration is going to be under review. But for now, both parties have made a clear commitment to respect their respective contractual obligations going forward.
Evan Wang: Great. And I had one last one on hMPV. It seems like maybe there’s more emphasis on partnering. Am I interpreting that right or is there still plans to bring that into clinical-stage development?
Thomas Lingelbach: So I would say, right now, so basically we have, as I mentioned earlier, we’ve reached the point of preclinical PoC completion. So, this means we need to take a clinical entry decision on this asset. But the point is that we are talking here about a pre-fusion candidate that requires an (ph). And standalone hMPV does not really make sense from a product development perspective. And the first trial in men is certainly very valuable. But whoever would then later combine this asset with an RSV vaccine would need to go largely back to the drawing board because of the specifics around adjuventation. Therefore, we have said we’ve given it a slight pause and look whether it would not be more valuable to bring this asset, at this point already, into a partnership model with one of the RSV candidates, and therefore have a more efficient development route.
Should this not be seen as a viable and value generating option, then we will certainly consider taking it into the clinic in order to increase the asset’s value.
Evan Wang: Great. Thanks, guys.
Operator: Thank you. We will now take the next question; it comes from the line of Max Herrmann from Stifel. Please go ahead, your line is open.
