But whether that means we will be able to, for example, increase the amount of fludarabine. We’re able to give patients — to give it a chance to be to activate more of the Gedeptin inside the tumor masses that are injected, whether that means we can either dial up or dial back the amount of injected adenovirus that carries the activated protein into the tumors. Those kinds of questions, we’ll get some sense from where we can take this study as we go into additional patients. Does that help you?
Vernon Bernardino: Yes. And as a follow-up, do you have any expectations on how many repeat cycles maybe possible, especially when you’re also giving fludarabine?
Kelly McKee: Well, so each cycle right now involves injection of Gedeptin through €“ three Gedeptin injections over a two day period followed by three days of fludarabine. Now — and it’s five cycles for each — up to five cycles for each patient. Now whether we can add additional cycles, whether additional cycles would be useful. We really don’t know that yet. And again, that’s — these are questions that we want to explore as we progress the development program, but we don’t have enough information right now to be able to make that decision.
Vernon Bernardino: Perfect. And do you expect to discuss data from the 10 patients with the FDA, you think that will be this year?
Kelly McKee: Yeah. I mean, we are obviously sort of constrained by how quickly we can enroll these final two patients and then if you sort of follow — if these final two patients follow the entire lifecycle program, we’re looking at basically six months from the time that the last patient is enrolled. So give us a month or so to analyze the data and pull it together, schedule a meeting with the FDA. So we’re hoping we’ll be able to get in front of them by the end of the year, but there are some factors that are sort of beyond our control in that regard.
Vernon Bernardino: Perfect. That’s very helpful and thanks for taking my questions.
Operator: Our next question comes from Jason McCarthy with Maxim Group. Please state your question.
Joanne Lee: Hi, this is Joanne Lee on the call for Jason McCarthy. Thanks for taking the question. Just two from me as most of my questions have already been answered. But firstly, I guess sort of from a broader perspective, do you guys have any numbers on, I guess, the proportion of patients who are getting regular boosting in revaccination? And would you expect this to be sort of the addressable population for your vaccine? Curious to hear your thoughts.
Kelly McKee: When you mean patients, you mean our hematologic malignancy population or who are you talking about specifically?
Joanne Lee: For the COVID, related to the COVID vaccine, I guess how many people are up to date and actively getting boosters and I guess, if your COVID vaccine that you’re currently developing would be addressable to this population of patients?
Kelly McKee: Well, I mean, I would anticipate that that, given the impact fact that this disease can have on an immunocompromised population of patients, virtually all of them will be getting regular boosters with mRNA vaccines according to the schedule prescribed by CDC and the cancer societies, but we don’t have any specific numbers in him (ph). What we do know is that the response that these patients generate to mRNA vaccines is suboptimal compared to that seen in normal healthy individuals and that they remain vulnerable to contracting severe illness when they get infected with this virus.
Joanne Lee: Great. Appreciate the color. And moving on, I guess, to the head and neck cancer trial, how large do you think the trial would go in terms of enrollment and what kind of response rate do you think would be clinically meaningful to advance the program? Thanks.
