B-OM's sample size is decent relative to the Phase 3 size, which should be ~200 patients. P's sample size is decent relative to the Phase 3 size, which should be ~500-600 under 505(b)(2).
Just like P, B-OM is a double-blind trial. If severe OM is prevented in a majority of patients where the SOC only shortens the duration, I'll be very surprised if the SP doesn't respond.
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