@cdoyle you accounting for the fact that we are on an expedited route as the actual drug being used has already been prescribed for years, its only the method of delivery that is being approved here? if it was a new drug and the method of delivery was also being approved, then yes those timelines would apply but i was under the impression this is sort of different. I'm not expecting FDA approval tomorrow but i also wasn't expecting q2 2026, again i actually don't have much knowledge on the FDA approval process so I'm happy to be corrected where i am wrong.
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