We’ll see but I believe the update has more to do with FDA’s exceptions to adquate and well controlled trials and potential unwanted legal challenges surrounding the update. Until final “approval” of the new methods for measuring PFS with approval of a BLA, the updates surrounding these methods are not “approved” rather they are “accepted” in principal as an adequate potential measure for this situation so avoiding confusion about the difference is prudent. There is now no confusion about OS primary as an approved measure being agreeable to FDA nor has there been since previous regulator updates. Best wishes.
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