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hemopure36

08/14/20 9:46 AM

#24456 RE: fantomphan #24454

As I've said here a couple times, it's more likely than not that the FDA will require a trial for Ticagrelor, but there's a very small chance they will not, in my opinion. However, that's not what the question here should be. On this board, as usual, the "no trial requirement" path seems to have become the baseline and requiring a trial would be negative, but only here. Most of us didn't even consider the possibility of no trial requirement until Dr. Chan recently uttered the word, "if" and someone here pointed it out. We've been told that the trial would be relatively fast and easy to execute. So my baseline is that a trial will be necessary and any decision about moving forward without a trial would be very unexpected. I do like that our new CMO is taking the lead on this and I'm confident he will shepherd this to approval with or without a trial.