John Vandermosten: Great, thank you. When we look at selling, general and administrative, how do we split that between, I guess, sales and marketing and general and administrative for this year?
John Gay: Yes, so if you think about bifurcating, if you will, the SG&A from our commercial business, it was about almost not quite $14 million, and quarter over quarter that spend has stayed–you know, Q4 to Q3 has been kind of relatively consistently. As it relates to what part of that relates to marketing, etc., that has also stayed consistent. Again, as it relates to our activities, I don’t know the exact percentage but I would say it’s fair to say that we expect our G&A as it relates to our–or SG&A, I should say, for the EPI Health business to stay between $4 million and $5 million on a quarterly basis.
John Vandermosten: Okay, and then final question on–you know, if we see approval for SB206, how will that incrementally affect sales and marketing expense as that’s rolled out? I know you have a lot of excess capacity, but there might be some other demands that need to be made. How should we think about that in 2024, assuming approval?
John Gay: Yes, I think there will obviously be some increase, but part of the main benefit of having the acquisition of EPI Health is that it will greatly reduce the amount of marketing spend, quote-unquote, that will be necessary for 206.
Paula Brown Stafford: I was going to say too, the sales, I think stay the same. The marketing might be what increases as we try to market, and as I mentioned earlier, it’s going to be relative to the financing–the funds that we have, how much we are able to market the product ahead or at launch.
John Vandermosten: Great, thank you.
Paula Brown Stafford: Thank you John.
John Gay: Thank you John.
Operator: Thank you. The next question is a follow-up from Oren Livnat with HC Wainwright.
Oren Livnat: Thanks for accommodating the follow-up. You mentioned earlier on the call, John, when discussing R&D that a top priority is certainly progressing to manufacturing activities, so you’re ready to launch if and when the time comes. Can you just talk about in general, what is left to do on that front? Is it just crossing Ts and dotting Is, and manufacturing, keeping things in compliance, or are you going to actually ramp up and build launch quantities ahead of January, and is that in your financial plan?I guess also, just de-risking-wise, are there any things left to do that, in your mind, represent, I guess risk, paths with regards to manufacturing? Are there things that need to be verified still in terms of scale-up or inspection with the FDA? Thanks.
Paula Brown Stafford: Thanks Oren. We are on track for the January PDUFA goal date and the normal course of that standard review. We here are producing in Durham, North Carolina our drug substance and we have submitted what we need to submit, and we are on track. I mean, there are usual processes that you go through in terms of process validation, etc., and so all of that is ongoing, no risks that we are aware of. We continue to progress and want to move toward manufacturing or a potential launch, and in terms of that de-risking and how much do you do ahead of an approval, the midcycle review would come sometime this summer and I think once we get through that, we’d like to be in a position to begin to manufacture product that would be available for a launch. I think John wanted to add–
