Sahil Kazmi: Excellent. Thank you very much for that. And then just the last question as you kind of think about the subsidiaries here, both Melt and Surface, it was really helpful to see an update from Surface discussing their dry eye program. But to the extent you have visibility, do you know when we can expect to see some of the Phase 2 data from Surface and kind of what are the next steps in the potential monetization of Melt after their pivotal data?
Mark Baum: Sure. So at the recent AECOS meeting in Aspen, Kamran Hosseini gave a nice talk about the Phase 2 chronic dry eye disease data for his drug candidate. I believe there is some publicly available video or audio related to that and what I will try to do is gather that and make it available to you. But he has spoken about his Phase 2 data. I know they are in discussions with strategics, the data was extraordinary and they continue to work towards a Phase 3 program for that asset, as well as the other programs that they have. In terms of Melt Pharmaceuticals, which we own 46% of, as well as a senior piece of debt and a 5% royalty on their MELT-300 program. They did report, once again, amazing data, Phase 2 data and it was really pivotal data in terms of efficacy for this program and they had really excellent sedation data.
They were able to demonstrate that their MK, their midazolam-ketamine combination product from a sedation perspective worked statistically significantly better than the midazolam alone, which is tough to do. Midazolam is a very good sedation drug, they were able to show Stat 6 on their MELT-300 program using the Zydis delivery technology. They have a meeting with FDA in the middle of May and it is an end of Phase 2 meeting to confirm what will be required in a Phase 3 program. And in the past, the FDA has indicated that the Phase 3 program would be against placebo. So active versus placebo, which is a very attractive prospect for Melt Pharmaceuticals, it’s a fairly derisked study. And so the company is going to FDA to confirm what would be required.
The FDA could change its mind. The FDA may confirm what they had previously said about what would be required. We will have to see, that will happen in mid-May, and then once that occurs, we would expect the company to work towards capitalizing itself so that it can complete that program, and ultimately, get that product out to market. We sell at Harrow through our ImprimisRx business a compounded lozenge. We call it the MKO Melt. It is the compounded product that really inspired us to create Melt Pharmaceuticals in the first place. And so once again, the idea is that if there’s an FDA-approved version of this product available, we would certainly prefer to sell the FDA approved product, make that available to the significant customer base that already purchases the compounded or a compounded version and so that’s really the idea there.
But unlike some other products, the MELT-300 product, if it’s approved, would not only be impactful in ophthalmology, it could be used in other areas outside of ophthalmology, dermatology, plastics, women’s health, ER medicine, colonoscopies potentially there are many, many uses for this we believe, as a novel IV-free and opioid-free sedation product.
Sahil Kazmi: Excellent. Really helpful overview, and once again, congrats on a really successful 2022 and look forward to following the story later this year. Thanks for taking our questions.
Mark Baum: Thank you, Sahil.
Operator: Seeing no further questions in the queue, I would like to turn the call back to Mark Baum for closing remarks.
