All right. Welcome back inside our proactive newsroom. Joining me now is Dr. Seth Letterman. He is the CEO of Tonics Pharmaceuticals and Dr. Letterman, welcome. Good to see you again. Great to see you, Steve. Thank you for having me on. Yeah. So the company had an opportunity to present some data at a major conference in Rome around TNX 102SL. So I'll let you pick it up from there. This is a pretty big scientific conference. Sure. Well, TNX 102SL is our new drug in development for fibromyalgia. And we expect to file the new drug application for TNX 102SL to FDA in October of this year. So it's very exciting for Tonics to be at the point of imminently filing our new drug application. There are not many biotech companies that get all the way from an idea to a product that's on the verge of being filed for approval. So in that vein, our product, TNX 102SL, is a novel and proprietary formulation of cyclobenzoprene. And it's designed to be taken at bedtime. And for that reason, we had to come up with a new formulation that was engineered to improve the speed of uptake. And also very importantly, to bypass the liver, what's called the first-pass hepatic metabolism. And in this conference, our formulation scientists, both within Tonics and also an important outside contract partner, presented data about the formulation. And Dr. Letterman, you mentioned that you're applying for that designation from the FDA. And this is after it's been heavily studied as well. You've done a number of clinical studies on this, and I'm sure that was brought up during this conference as well. Yes, although this conference was mostly focused on the formulation science. In one of the oral presentations, one of our scientists was invited to do an oral presentation, and he went through some of the clinical trial results. And we expect TNX 102SL to be, if approved, it would be the first new drug approved for fibromyalgia in more than 15 years. And since we've guided that we expect to file the new drug application in October, then we would expect a decision on FDA approval in 2025. Okay. And lastly, just on the uses for this, I know you've talked about it in the past in interviews that we've done just about the need for this. And as you mentioned, it's been quite a while since a new fibromyalgia drug has been available. So there is a great need for what you're talking about. Yes, fibromyalgia patients in in this is based on literature and some work that we've commissioned that we've discussed before, for example, a report by a consulting firm called Eversana has found that there is dissatisfaction among patients, even though there are three approved three FDA approved medicines for fibromyalgia, the side effects limit their use and and all drugs are, you know, risk reward benefit of benefit versus side effect. So we've now have two statistically significant phase three studies supporting the approval of our drug. And in those studies, we have found our product to be well tolerated and activity in fibromyalgia that we think should be sufficient for a decision by FDA. All right, well, we look forward to hearing more about that with the time is right. Dr. Letterman, thank you so much. Good update and good to see you as well. Thank you. All right, Dr. Seth Letterman, the CEO of tonics pharmaceuticals.
