Infact it was the up titrating that the CEO used as his excuse for why we wouldnt see the same rates of AE in the upper dose as we did in the Ph2, which really didn't convince me.
i think one problem they could face from a whole lot of patients titrating up then stepping back down again would be not having enough upper dose patient data to support label inclusion.
im just remembering now some statement they made about making the Ph3 "adaptive" such that they can add more patients if they think they need to. I read this as few patients are staying at the upper dose, probs need more patients for sufficient power to hit significance at the lower dose.
Infact it was the up titrating that the CEO used as his excuse...
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