So again, it’s really important that we get the FDA’s confirmation on that, and we do not have that yet. We’re also asking them to give us guidance on the number of patients, and again based on previous discussions with the FDA, we are guestimating or estimating that it be somewhere between 100 and 200 patients. But we weren’t €“ you know we need to get that confirmation from them, and we also want their feedback, very importantly on how they want us to define a hypotensive event. Remember, this is a safety study and the primary endpoint is hypotensive events, you know comparing the number of hypotensive events between the oral and the GTX-104 IV. So you know, we’ve asked for their guidance on €“ you know, should it be based on €“ you know what threshold should it be based on; systolic only, diastolic or you know sysolic, so we’re really waiting on that.
That’s really a key piece of information. And finally, as I think you know, we’ve discussed this. We’ve asked them to comment on the various exploratory endpoints that we’d like or I shouldn’t call them end points; the various exploratory data that we want to collect. We want to do sparse PK sampling of the patient population to build on our, you know PK CD modeling. We’re going to collect some efficacy and pharmacoeconomic data that you know really for publication purposes. So really you know this is a long way of answering your question, but it’s really important that we get that clarification before we really finalize the protocol design and start this study.
Q – Oren Livnat: And I might have missed it, but did you already have that meeting?
Jan D’Alvise: No.
Q – Oren Livnat: Okay. Is that expected or are things dragging just at the FDA agency in general or has there been €“ is there been some back and forth?
Jan D’Alvise: You know things are dragging, you know absolutely, and you know the FDA has indicated that they are short staffed. You know and again, we’ve had good communication with them. So you know I just think, you know we expected you know to get this soon, and as soon as we get it, obviously we’ll be putting out the information that we get.
Q – Oren Livnat: Okay. And big picture, commercially on 104 you know, as the stuff is going on separately, it’s obviously a pretty concentrated market. Has there been further process in your relationships with you know big centers of excellence and the associated KOLs there that theoretically or helping you continue to you know prime the palm for later groundwork for excitements and rapid adoption if and when this thing works and is approved.
Jan D’Alvise: Yeah, you know I’ll just make a quick comment and then I’ll hand it over to Prashant to expand. But you know as we begin to identify and qualify sites, you know we’re building on relationships we have and expanding those relationships. But let me pass it over to Prashant. Prashant, do you want to add anything there?
