[my theory-crafting only] BOT believe/suspect, as many on HC do, that there is a mistake/mislabel/other issue at the US manufacturer. unfortunately, they are unable to prove it. (lack of posterity samples from all 11x batches) - i think this is the key. if they know they can never prove the issue, what else can be done?
therefore, they release the data as it stands, highlighting the obvious discrepancy. proceed to phase 3 with much better manufacturing processes/controls, knowing the next round of results will put proof in the puddin' [IMO]
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- Ann: BTX 1503 Acne Phase 2 Study Results Presentation
Ann: BTX 1503 Acne Phase 2 Study Results Presentation, page-232
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