What are the trials, patient preference studies, and other evidence supporting your approach for deploying DTE in clinically appropriate populations, and in what percentage of patients with hypothyroidism does DTE become the treatment modality of choice?
So there have been pre-clinical studies that have looked at mice populations, um, and mice that have had their total thyroidectomy done. And when you've had a total thyroidectomy, not only are you losing the T4 portion of what the thyroid produces, but you're losing about 20% of your T3 as well. And so in those mouse models after total thyroidectomy, um, they did find that when those mice were placed on T4 monotherapy, they had significantly lower T3 than mice that did not have a total thyroidectomy that were um the control mice. Suggesting maybe that there was something to um total thyroidectomy and losing maybe that 20% reserve of T3 within the thyroid gland itself that significantly lowered the T3 homeostasis in the body and may translate into humans and into the clinic and maybe explain why some patients still feel bad on T4 monotherapy. We see that clinically as well, um, you know, after a total thyroidectomy when patients lose, um, that 20% of their T3 from the thyroid, a lot of them do end up needing T4-T3 combination therapy, not all of them, but a lot of them do, um, and you know we have also, um, had some good. Um, clinical data on humans, it's not, it's not a randomized control trial, but it is preference studies looking at whether patients prefer T4 monotherapy, um, or DTE products, and, um, those have been in the forms of, um. You know, patient questionnaires. There was a big study that was published actually in Thyroid that looked at thousands of patients and whether they preferred DTE versus T4 monotherapy versus T4-T3 combination therapy. And in that questionnaire, a majority preferred DTE products. There was also a white paper that was written by the American Thyroid Association that talked about who would be a candidate for T4-T3 combination therapy. And in that paper, they reviewed a lot of the basic um pre-clinical studies and some of what we have for, for human studies, and they concluded that about 15% of patients who have hypothyroidism may in fact require T4-T3 combination therapy or DTE. Um, they did review the, the pre-clinical work, um, in mice and rats after total thyroidectomy as a potential reason for requiring, um, combination therapy. And, um, they also, uh, spoke about maybe a genetic component to DIONase 2 maybe not being as, as active, um. The verdict for the why of this all is not well established in the research literature, but we do know that in animal studies, it does seem to be the case that T4 monotherapy after total. Thyroidectomy comes away with a lower free T3 level in these animals, and we do know that patient preference studies do prefer DTE products, um, especially if they've had a total thyroidectomy.
