Dr. Zamaneh Mikhak: Yes. Yes, we think just about 10 patients would be sufficient for us to make a call about TFF TAC as well. As I mentioned, we’ve enrolled three patients. With our first patient, it was the first time we were transitioning patients from oral tacrolimus to inhaled tacrolimus. So, we approached it very conservatively, watching that patient very carefully, making the transition and then very slowly leaning that dose of inhaled tacrolimus because you have to have — you have to be careful about that balance of making sure the patients have been going to rejection while you’re improving prospects of safety and tolerability. And we — as I mentioned, we were surprised of how low we were able to go in the TFF TAC dose.
With the second patient, we implemented our learnings from the first patient and were able to duplicate those observations. So obviously, we want to see that happening in a number of other patients, but we think 10 — approximately 10 patients will be sufficient to give us the information we need to make a call that, yes, this is a goal into Phase 3. And obviously, you continue always to learn from additional patients you bring in, also at your development program. But approximately 10 patients should be sufficient.
Vernon Bernardino: Great. I look forward to that decision. Now I know an Expanded Access Program is generally not one designed to provide results, for example. But the Expanded Access Program, especially with your drugs, TFF VORI and TAC, in particular, the voriconazole study, as you mentioned, the small number of patients. Would there be a possibility to give any kind of data and/or results from that program and would — especially with the help of Durbin Ireland or Uniphar rather provide a perhaps broad coverage of the kind of patients globally that you could, I guess, put together, translate, synthesize, whatever — however you want to describe it into the results that you might see with TFF VORI?
Dr. Harlan Weisman: Why don’t you go ahead Zamaneh and take that one, too?
Dr. Zamaneh Mikhak: Sure. Yes. We believe that the information we gather through the Expanded Access Program will add to the knowledge base that we’re going to have about TFF VORI and its potential. We are developing TFF VORI by conducting a clinical trial, and the results of the clinical trial will lead us and help us, guide us to understand our next steps and the design of our Phase 3, et cetera. But the information we are gathering through the Expanded Access Program is very valuable and adds to that. It also really expands the indications that we are in. The clinical trial is in invasive pulmonary aspergillosis, Expanded Access Program gives the opportunity for TFF VORI to be in five additional indications, which is really significant. So, that information is really helpful to us also to understand where are the signals of efficacy where we should be pursuing further clinical trials for TFF VORI.
Dr. Harlan Weisman : Probably we are — I just wanted to, I’m sorry, just mentioned that, you brought up Durbin. And one of the reasons for us signing on with Durban is that it — we have — although it’s not a formal clinical trial protocol, we do have a data collection mechanism that would provide us with uniformity, across the various patients that come into the compassionate use program. So it’s not with the same degree of rigor, but there is a systematic data collection that’s planned that would allow us to characterize the patients and the outcomes. Zamaneh, I don’t know if you want to…
Vernon Bernardino: Sure. That’s exactly what I was looking for. Yes. Terrific. That’s exactly what I was looking for. And then, secondarily, I know you have cash, as Kirk said, through perhaps third quarter 2024. My model makes it easy to see that is certainly true. But if you had additional cash, what other molecules do you think you might think about advancing into clinic and make good sense in whether they be a small studies or just even a proof-of-concept studies, where you could generate results that would provide just additional opportunities for our partnerships.
