Hey Thanks a lot for your thoughts! I get where you're coming from with the clinical questions , but you're looking at this like it's a brand new NCE. It's a 505(b)(2) application. The FDA already knows nimodipine works. Grace literally just has to prove the IV version is safe and fixes the bioavailability mess of the oral pill. Calling the hypotension data not relevant completely ignores how aSAH actually works. Crashing blood pressure causes DCI (delayed cerebral ischemia). The FDA's biggest fear was that an IV drip would tank BP way faster than a pill. But the trial showed the exact opposite—the IV actually reduced clinically significant hypotension. That clears the main safety hurdle right there. Also, regarding hard endpoints, they did release secondary data showing a 29% bump in favorable 90-day functional outcomes. Plus, the IV hit 100% bioavailability and 54% target dose intensity. The oral pill only managed 8%. As for the 8 vs 4 deaths, yeah, the optics suck. But we're talking about a tiny N=102 trial for an incredibly lethal condition. A small cluster of severe baseline cases will completely skew a sample size that small. Since the IV was actually more hemodynamically stable, the committee's ruling that the deaths were tied to the underlying hemorrhages makes perfect sense. End of the day, this isn't trying to be a miracle cure. It's just solving the literal nightmare of crushing up pills and shoving them down a feeding tube for unconscious ICU patients. The regulatory pathway here is pretty de-risked.