Leland Gershell: Mitch, thank you for the update and for taking our questions. Just to get into specifics to the extent you’re able to with respect to the ongoing FDA discussions, can you say that you are continuing to discuss the design of what may be a confirmatory trial that would be performed under the EUA? Is that a part of the ongoing discussion content?
Mitchell Steiner: What I can tell you, which is public, is the FDA stated in their background package that the design that they laid out was agreed upon by the sponsor. So, it’s there. And so, that’s not the top discussion point because that’s been agreed upon. I think I can’t say much more than that except right now in the black box of the FDA, they’re checking their boxes that they need to check.
Leland Gershell: Can you comment if there are any particular boxes that are left to check that you’re working to check?
Mitchell Steiner: I can’t say much more.
Leland Gershell: Okay. And then with respect to the other countries, has there been any change in in their interest since the advisory committee and whether there has or not or whether you can comment or not, are you aware of any dependence on what the EUA decision outcome will have in terms of what those ex-U.S. decisions maybe versus independent, it could be independent emergency authorizations and other places irrespective or prior to an FDA decision?
Mitchell Steiner: Yes. So, let me see if I can give you some color on that. So, the question is basically, have you noticed any changes in the interactions that we’re having with other governments that are reviewing our application based on the advisory committee? And the answer is no. In fact, what we see is intense discussions with other regulatory agencies outside the U.S. To put this in perspective and using Remdesivir as an analog, especially the last six months that was reported by Gilead, almost 52% to 53% of their revenue, they reported I think revenue of $1.9 billion for the first half of the year. It was coming from outside the U.S. and a big bulk of that was coming from Europe. The point I’m trying to make is that when you’re looking at the COVID-19 drug, the split of 65% in the U.S. and 35% outside the U.S. doesn’t make sense.
It’s very different. And when you look at that, the major markets then turn out to be Europe, and all the countries that follow Europe. So, if Europe gives you an emergency use authorization similar, than 80% of the countries outside of Europe will use that authorization as part of their review or in lieu with their review, okay, because €“ and it makes sense. So, if you get U.S., you get Europe, you get both. And those are the major markets you’re good to go and have significant revenue, but I will tell you that there has not been at all any change in the interactions that we’ve had with, as I mentioned in the prepared comments, with multiple agencies, and the multiple agencies remain engaged and active in their review. And so, no, the answer is no.
The answer is, it appears to be quite independent. And as I mentioned, the FDA is still reviewing the application. So, I’m not quite sure what to make out of the AdCom.
Leland Gershell: Okay. And then just one question on the other development programs. Just with our test and veracity, I believe you’d indicated around the time that those trials were getting going that we could see enrollment starting to complete, kind of in this timeframe. Just wanted to ask about enrollment progress with those. And if you do see either of both trials perhaps completing enrollment by year-end or what that timeframe is looking like?
Mitchell Steiner: Yes. So, the timeframe still looks like data in €“ end of next year kind of timeframe and they’re event driven. And so, enrollment is still consistent with that, but that’s all I can say at this point.
Leland Gershell: Okay, great. Thanks for taking the questions.
Mitchell Steiner: Thank you.
Operator: Our next question comes from Chris Howerton from Jefferies. Please go ahead.
Chris Howerton: Hey, good morning. Thanks for taking the questions. I guess, two from me. One would be, with respect to the FC2 and ENTADFI part of your business, what measures are you going to take in your own internal hub to, kind of combat some of the challenges that your partner had for the telemedicine and I guess to give you confidence that that will be a sustainable business? And then I guess I’m just curious if you can give us some more color around liquidity and your cash runway in a scenario where sabizabulin has launched? What would be your cash needs to launch such a drug? And in a scenario where maybe there’s a longer delay, how do you see your current cash reserves being deployed against your plan? Thank you.
