Greg Duncan: The Bateman Horne Center program is funded, so we do not need to raise any additional capital to run that program. We will look towards partnership and potentially non-dilutive funding through NHLBI and NIH under the RECOVER umbrella to potentially fund that mix confirmatory dose-ranging study because we’d like to look at multiple doses in that secondary trial. That would require partnership or non-dilutive funding. But as you probably have seen under recent headlines, both scientific and Lay Press, there was a lot of information about characterizing long COVID and I think NIH and NHLBI are now repurposing their focus to focus more in on treatments. I think everybody realizes long COVID is here to stay as a consequence.
Long COVID is here as a result of this continuing new pathogens, new — I think it’s the E5 variation now that we’re on, something of that ilk. This is going to be like the flu, and I think long COVID will follow these new versions of COVID. So this could be very timely and very, very helpful for patients.
David Bautz: Okay. Great. Thanks for taking the questions this morning.
Greg Duncan: Of course, of course. Thank you, David.
Operator: Thank you. The next question is coming from Sean Lee from H.C. Wainwright. Sean, your line is live.
Sean Lee: Good morning, Greg, and thanks for taking my question. I just have two quick ones. First is on the upcoming new long COVID study. So other than being double-blind and randomized, how is it — is there any differences between the proposed study and what has been completed so far, the payment and all?
Greg Duncan: So, excellent question, Sean, and thank you for joining in for your question. As Mike outlined, the original exploratory trial was open-label in its approach, and I think you’d probably agree, executing at the same center, same conditions, same outcomes under double-blind conditions is a higher hurdle rate. And so we are looking to validate that particular finding and we’ll commence that program this fall that is fully funded. So what we’d like to do is actually validate that study under more classic double-blind placebo control conditions. At the same time, as we referenced, we do think a more classic Phase 2B, and who knows where the conversations with FDA goes. We need to talk to them about what outcomes they think are important here, how they would like us to explore different doses for long COVID.
One of the other questions which we didn’t mention, but I think is important to reference in the context of your question, Sean, is we will also ask the FDA about broader fatigue opportunities. If you look historically at these combinations, be it the Phase 2a fibromyalgia trial, the Phase 2b fibromyalgia trial, and now this exploratory long COVID trial, the impact on fatigue is robust, statistically significant and consistent across all of those three studies. We do think it’s early days, but our initial thought process is given the robustness, consistency and concordance of this signal across all three studies, would it make sense to potentially explore this particular combination in a broader suite of fatigue-related disorders, whether that’s myalgic encephalomyelitis or chronic fatigue syndrome, as it’s more classically known, or some other form of fatigue also represents an opportunity?
So that pre-IND meeting will certainly be mostly focused on long COVID, but we do think there is a potential to expand that research given the consistency of the signal to potentially other fatigue-related disorders. Does that answer your question?
Sean Lee: Yeah, that’s part of it. The other part is for the randomized study. It’s in terms of endpoints and patient enrollment patient selection. I mean, and also study size. Is there any differences compared to the previously completed study?
