BIOXCEL THERAPEUT DL-,001 WKN: A2JF20 ISIN: US09075P1057 Kürzel: BTAI Forum: Aktien Thema: Hauptdiskussion
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.
Post wurde gelöscht.
|
Thema | ||
---|---|---|---|
1 | BBBBY - Insolvenz möglich? | ±0,00 % | |
2 | GAMESTOP Hauptdiskussion | -0,77 % | |
3 | Kroatischer Brokerimbiss 1.0 | +0,71 % | |
4 | Lilium Aktie | +3,06 % | |
5 | RHEINMETALL Hauptdiskussion | +0,73 % | |
6 | TESLA MOTORS Hauptdiskussion | -1,44 % | |
7 | Cypher | ±0,00 % | |
8 | Palantir | +3,86 % | |
9 | GeoVax Labs Hauptdiskussion | +12,63 % | |
10 | JINKOSOLAR Hauptdiskussion | -5,83 % | Alle Diskussionen |
|
Thema | ||
---|---|---|---|
1 | BBBBY - Insolvenz möglich? | ±0,00 % | |
2 | GAMESTOP Hauptdiskussion | -0,77 % | |
3 | Kroatischer Brokerimbiss 1.0 | -0,83 % | |
4 | Cypher | ±0,00 % | |
5 | TESLA MOTORS Hauptdiskussion | -1,44 % | |
6 | Palantir | +3,86 % | |
7 | Vicinity Motor Corp. | -6,03 % | |
8 | GeoVax Labs Hauptdiskussion | +12,63 % | |
9 | JINKOSOLAR Hauptdiskussion | -5,83 % | |
10 | was hier los ??? | -15,05 % | Alle Diskussionen |