Dr. Harlan Weisman: Yes. Good morning, Justin. Thank you for the question. That one seems like another perfect one for Zamaneh to address.
Dr. Zamaneh Mikhak: Thank you, Justin. So, we will look at signals of efficacy. For example, in TFF VORI, we certainly want to see that patients are feeling better, the clinical signs and symptoms have improved, and we like to see that there is evidence that aspergillus has been cleared. The treatment duration is about 12 weeks. That may or may not be long enough to see radiologic evidence, but we certainly look for it, and we expect to see that at least in some patients. In the TFF TAC program, for example, we want to make sure that as we transition patients from the oral tacrolimus to the inhaled tacrolimus, we continue to see that patients are free of rejection. And that they are shown good signs of safety and tolerability. And of course safety and tolerability is big for TFF VORI as well.
Justin Walsh: Got it. And did you discussions with the FDA or the EMA related to the amendment of the trial?
Dr. Zamaneh Mikhak: We made the amendment, and we submitted it to the health authorities in the various countries we’re in, in Europe, and they’ve been approved in 4 out of 5 countries, and it’s under review in the 5th country.
Justin Walsh: Got it. And then last question for me, you had mentioned the hospice and some of that angle here. But I’m just wondering if you can remind us or provide commentary on the expanded access and compassionate use of TFF VORI. What alternatives do these patients face, either in terms of standard-of-care or other experimental therapies that you might be aware of?
Dr. Zamaneh Mikhak: So the Expanded Access Program really provides the opportunity for patients who might benefit from TFF VORI to get access to it. And the patients who might benefit from this therapy are not just patients who have invasive pulmonary aspergillosis. There are many other indications for which TFF VORI could be helpful, chronic pulmonary aspergillosis, ABPA, in patients with lung transplant, bronchoanastomotic infections. There are many areas, and also fungal infections that are not aspergillus but are voriconazole sensitive. So, every time you do a clinical trial, you have a clinical trial protocol, you have to implement and cement a particular design. And once that design is cemented, then there are patients who don’t qualify based on one thing or another.
So the Expanded Access Program really helps us get TFF VORI in the hands of patients who could potentially benefit from it. And these are patients, like you mentioned, who have tried standard-of-care therapy at adequate levels and they have not had a good response to it or because of systemic toxicities are not able to tolerate these drugs. The two patients we had for compassionate use that were treated previously, for example, were patients who were lung transplant recipients, they had recurrent pulmonary infections — pulmonary fungal infections. And they had significant toxicities to the point that when their infection came back, they were at the end of their rope. And they didn’t have — they didn’t know where to go, and that’s where TFF VORI was given to them with very good results.
Did that answer your question?
Justin Walsh: Yes.
Operator: The next question comes from Vernon Bernardino from H.C. Wainwright. Please go ahead.
Vernon Bernardino: Your answers as far as the VORI program have been very informative. So I think I know the answer to my question. Regarding the Phase 2 TFF TAC program, though, do you think that the small number of patients that are going to be dosed with the — in the TAC clinical trial will be predicted enough to also make a go/no-go decision for Phase 3?
Dr. Harlan Weisman: Why don’t you go ahead and take that, Zamaneh?
