I'm just worried if FDA will think of phase II results as 'effective' enough or not. If you take all the data together then certainly it's not 'effective' enough as the primary endpoint is not met. If you only view Oz data, it is certainly 'effective' enough, but management needs to convince FDA that US data is definitely incorrect. To prove that's incorrect they need to give possible reasons.. and the reason they are currently giving us is not very plausible (multiple suppliers and manufacturing issues). Don't know if FDA will buy it.
But if having met one of the secondary endpoints is already enough for FDA to approve progressing to Ph3 then maybe they don't need to try to come up with another more convincing explanation...
Ann: BTX 1503 Acne Phase 2 Study Results Presentation, page-534
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