BIOXCEL THERAPEUT DL-,001 Forum: Community User: Adler.

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the FDA indicated that we should conduct a further clinical trial to evaluate safety and collect efficacy data of BXCL501 in the at-home setting before we are able to submit an sNDA seeking approval of BXCL501 for use in such populations. These requirements for submission of an sNDA will be further discussed with the FDA at a forthcoming meeting.... (Feb. 20) At this meeting, we intend to propose to conduct a randomized, double blind, placebo-controlled, 2-arm study of 100 patients in which safety and feasibility will be assessed as the primary endpoints over a 4-week treatment period. We also intend to propose that we should not assess efficacy in this trial since we believe there are no well-defined and validated measures of efficacy for the at-home setting of acute agitation as measured by the caregiver, notwithstanding that the FDA stated that we should collect such efficacy data at our October 2023 meeting.

Verzeihen sie aber verstehen sie nicht was ich sagen will ? Man kann in amerikanische Aktien investieren auf einem DEUTSCHEN Forum ! Wenn sie der Sprache nicht mächtig sind ist das kein Problem ! Aber hier englische Texte reinzukopieren ist mehr als respektlos !