Roanna Ruiz: Great. Thanks, and afternoon, everyone. Appreciate you walking us through the Dengue results. So I’ll start there. I was curious if you could clarify which factors seem to contribute the most to the unavailable results for DEFEND-2 sourcing different things like it may possibly trial execution, maybe there were some placebo arm trends that were difficult to interpret. And were you able to garner anything about the possible the potency of 752 in this trial.
Jean Sommadossi: I’m going to let the Arantxa but in terms of potency as I have indicated, I’m going to let Arantxa that, let’s not forget that fever is the major clinical sign of dengue. So Arantxa why don’t you address the question, please?
Arantxa Horga: Yes, thank you. Thank you for the question. So — might contributed through the viral unavailable. I think the main reason is that the patients tend to come later in the course of the disease. And as you can see in the slide a lot of them particularly in the placebo have already either low or undetectable viral by the time, they come to you and they come to you later. It’s not unusual. We mandate 40 hours fever criteria but patients sometimes have a hard time identifying really when the fever started exactly. And so they probably came later, presented later by the time we were able to enroll them. Another factor is that the test that we use for enrollment NS1 antigen is an antigen test. And as you seen with COVID antigen tests are not often very sensitive.
They’re not as sensitive as PCR but sites don’t have PCRs available. So we will need to develop better more sensitive diagnostic tests if we want to advance programs like this. So those are contributing factors. And with regards to the efficacy question, I think what we have seen in this data is a resolution of fever that is factoring more rapidly active and as you know fever is being clinical sign for dengue. In fact, it’s called dengue fever. And so we think that the resolution, faster resolution of fever, even considering such a small data set, is quite interesting and promising a signal in this trial.
Roanna Ruiz: Got it. Thanks for clarifying. And another question on the COVID program. So could you remind us, what do you want to see in the SUNRISE-3 interim to encourage you to move forward and if we fast forward and get positive final results, do you still think EUA is on the table with the FDA?
Jean Sommadossi: Janet?
Janet Hammond : So we’re planning to do an interim analysis when we achieve enrollment of 60% of the patient population in the study. And as you know, the primary endpoint is proportion of patients who require hospitalization. So we’re looking to see something to suggest that we’re going to an overall hospitalization rate in the patient population of ideally 4% to 6% is what we’re anticipating. And we still think that actually in the patient population that we’re going after in the study, that this is not an unreasonable number. And there have actually been some recent articles coming out, I think, in support of that. So that’s where we plan to be there.
Operator: This question comes from the line of Umer Raffat of Evercore ISI.
Jessica Hui: Hi. This is Jessica Hui on for Umar. Just one question. We’re trying to reconcile the SUNRISE-3 study design with that of a competitor oral COVID antiviral especially in light of the announcement last month that the COVID public health emergency will end in May. Specifically, the FDA took issue with a placebo controlled study in the US. So I just want to confirm that in the SUNRISE-3, the randomized monotherapy population will still include US patients. And you don’t expect the FDA to want you to change your trial design?
Jean Sommadossi: The short answer is no. But Janet wanted to expand on my answer.
