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BTAI / BioXcel: Data Integrity Concerns Muddy Regulatory Outlook (Rating Downgrade)

BioXcel: Data Integrity Concerns Muddy Regulatory Outlook (Rating Downgrade)
BioXcel Therapeutics faces regulatory challenges after the FDA found inconsistencies in one of its clinical trial sites, jeopardizing the supplementary approval of its drug, IGALMI. BioXcel's initiated an internal investigation and independent audit in response, but doubts persist about their commitment to regulatory compliance and ethical conduct, potentially impacting their industry reputation. Given the regulatory uncertainties and the company's existing marketing issues, I have revised my investment recommendation to a "Strong Sell" for BioXcel. Read More
Posted: Jun 30 2023, 18:27
Author Name: Seeking Alpha
Views: 112524

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