Eton stated there are no outstanding IRs or deficiencies for ET-400 ahead of its May 28 PDUFA date. What does this imply in terms of FDA likelihood for timely approval and how common is this level of clarity in late-stage filings?

How does ET-400 compare pharmacologically and logistically with compounded oral suspensions, especially considering the FDA's prohibition against compounded copies once an approved alternative exists?

Eton positions ET-400 as complementary to Alkindi Sprinkle. How do these two products differ in real-world clinical use, and what does this mean for payer coverage and prescriber preference?

With 50% of patients still using compounded or homemade hydrocortisone, what percentage of that market do you believe ET-400 can realistically convert within its first 12–18 months post-approval?

Eton claims commercial launch will occur within a week of approval. What operational steps need to be in place to ensure success in such a fast turnaround, especially in ultra-rare markets?

Assuming ET-400 launches in Q3 2025, how pivotal is this product for reaching Eton’s $80M end-of-year revenue run rate, especially given the projected $50M+ annual sales potential for ET-400 and Alkindi combined?

What are some unique formulation or delivery challenges that ET-400 solves compared to traditional steroid therapies in pediatric adrenal insufficiency?

Upon FDA approval, how likely is it that ET-400 could influence pediatric endocrinology guidelines or shift clinical preference away from non-approved compounded alternatives?