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

Na das war doch zu erwarten. Beste Grüße Wiolant

Ruhig geworden hier

Da immer wieder danach gefragt wird, hier nochmal die Primärquelle: https://ir.bioxceltherapeutics.com/node/11211/html Darin sind übrigens auch die Risiken aufgelistet, welche hier gerne mal von den Optimismus-Hardlinern unter den Teppich gekehrt wurden: "For example, even if the Company’s investigation and the independent audit conclude that data from the TRANQUILITY II trial have not been affected or compromised by the principal investigator’s actions or other deficiencies at the trial site, the FDA may not accept or agree with the Company’s conclusions or analyses, or may interpret or weigh their importance differently. Further, if the Company or the FDA determines that there are issues with data integrity and/or compliance with good clinical practice requirements at the trial site, the Company may be unable to use some or all of the subject data generated at this clinical site to support a marketing application. If all or a substantial portion of such data were discarded, the TRANQUILITY II trial may no longer be adequately powered for statistical significance and the Company may need to conduct a new clinical trial. If the Company conducts a new Phase 3 trial, such trial may have different safety or efficacy results from the topline data the Company is announcing today. Topline data from the TRANQUILITY II trial, including results from subjects at this principal investigator’s site, may not be predictive of the results in any new trial. Further, any investigation, disqualification or debarment of, or proceeding or action against the principal investigator, or any investigation, proceeding or action against the Company, could further delay development and approval of BXCL501 for this indication, and otherwise have a material adverse effect on the Company, its financial condition, results of operations and prospects."