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10/15/22 8:25 AM

#152123 RE: chereb19 #152122

Obviously no, he's not anticipating meeting delayed, but rather he's not anticipating a short path forward coming out of meeting. Should have an idea by middle of next week. It's understandable. MK was so positive after May 20 meeting, and here we are almost 5 months later still without an animal test plan. And we're now 13 months past the last IDE submission forecast.