The similar 12% placebo vs 14% treated non-up titration population only reveals the problem with titration compared to no titration in which patients are given the targeted dose directly. In another word, these 12-14% patients were not treated with target dose because “they can’t tolerate the perceived dose change”.
“little difference in efficacy between 30mg and 50mg” is even more worrisome. FDA wants to see definitive dose dependent efficacy in p2s as shown in PDD and confirmation with the definitive treatment dose in p3s. “little difference in efficacy between 30mg and 50mg‘ accomplished neither unless say 30mg max for Rett and 50mg max for AD. The higher the better depending on tolerance till PM is figured out.
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