James Cummings: I sure will. So, in terms of your second question, first, I guess. This phase 2b study that would be executed is just that. It’s a clinical trial under the auspices of the good clinical practice guidelines and rules and regulations from the FDA. So, it requires GMP-manufactured material, which is what we use in all of our clinical trials. So, I think that should square that away. The comparator vaccine will be an approved mRNA needle-injected vaccine, and we’ll be comparing the efficacy of both of those vaccines, or candidate vaccines, against one another. We’ll also be looking at safety. We, in our platform, have a very, fortunately, very clean safety profile, and we’ll be comparing that to the solicited and unsolicited adverse events, both from our product, but also from that needle-based injection of an mRNA booster. And we’ll be looking at that data as well. What was your second question?
Madison Britt Wynne El-Saadi: Secondly, a follow up to the prior question. In the event, after your meeting with the FDA, in the event that you were to run a challenge study, just curious how fast you guys could initiate that?
James Cummings: Well, I think there’s, it just depends on what the guidance of the FDA really tells us, right? So, I don’t want to speak for the agency or make any assumptions until after we have that meeting. That said, the good news is that there are groups that have been refining what is that challenge model in the United States. So, I think we could, in relatively short order, move forward with a challenge study. I can’t be more specific than that until we have the dialogue with the agency.
Madison Britt Wynne El-Saadi: Understood. Thanks.
Operator: Thank you. I would now like to turn the call back over to Ed Berg for further questions.
Edward Berg: Thank you, operator. We’ll now turn to questions submitted by our shareholders. So, the first question is for Mike Finney. Incoming CEO Steve Lo has had success in first product commercialization. Was that the primary factor in your search? What other attributes did you consider, and how did you make this selection?
Michael Finney: Well, regulatory and commercialization experience are, of course, important, but the board was looking for an all-around performer, and I think we found that with Steve.
Edward Berg: Thanks, Mike. Our next question, what is the timing for next steps for norovirus? This is on timing. Following your FDA meeting in Q2, and James, I think you’ve answered some portion of this, but I’ll turn to you?
James Cummings: Sure. So, timing and next steps will, as I mentioned, be dependent on the dialogue with the FDA, right? We’ll assess at that time and look forward to providing an update to anyone really who’s interested after we have that meeting. The nice thing is there’s a couple of ways we see looking at the impact of how a next step would be, whether it’s, with the Phase 2b dose confirmation study for more safety data, whether it’s for a challenge study that may be required or may not be required, to give more information on the correlates of protection, and then with the whole idea of looking downrange to a potential Phase 3 study. That’s the goal.
Edward Berg: Thanks, James. Another question on norovirus. Will you be disclosing the results of your norovirus data analysis and the correlate of protection? Sean, I think this is yours.
Sean Tucker: Yeah. I’d be obviously very excited about the work we’ve done, and, of course, we will share our findings with you after we gather its input, and then we’ll assess the next steps for the program. And once all that’s done, we also plan to submit a peer-reviewed manuscript, and again, the timing of that will be determined at a future date.
Edward Berg: Thanks, Sean. Next question, please elaborate on the preparations for the Phase 2b COVID trial. When do you expect to complete preparations? James, I believe this is yours.
James Cummings: Sure. So, we’ve been coordinating with our colleagues at BARDA, and we’ve done, I think, a great job in terms of moving forward, progressing with preparation for the what is a really significant endeavor, a Phase 2b study of 10,000 enrollees. Once we have that completed, we will update you.
Edward Berg: Okay. Thanks. That is all the questions we have at this time. So, I want to thank everyone today for joining us, and this concludes today’s call. Thank you.
Michael Finney: Thank you, Ed.
Operator: You may disconnect your lines at this time. And have a wonderful day. We thank you for your participation.
