General Comments / Chat, page-10308

Patch my head hurts after reading your posts lol

RC220 Circa 6 months
P1 12-18 months - FDA has 30 days to review an IND, Maybe they make submission at the same time Aus kicks off in H2 - Mostly Aus sites to keep costs down but throw in a US site or 2 in prep for opening a P2 there as well. Remember trial is Bayesian design so allows some flexibility and advantages with the accumulation and reporting of data (recommend going and reading up on this)
P2 likely starts H1 2026 - 18 - 24 months we are in 2028
To hit your timelines, Approval would need to be granted off Interim data. Not sure how many cases of it happening off P1 data, but there is precedent off early P2.

FDA = "In situations where standard-of-care exists, a distinction between small, incremental improvements, and game-changing effects must be made in order for Breakthrough Therapy designation to be granted"

Id assume the end points RAC have come up with are not just wild guesses and fairly well researched, to be enough to be granted use if it demonstrates any sort of efficacy as cardioprotective. Of course all of these timelines matter for approval and not a transaction.