The filed complaint alleges that defendants made false statements and/or concealed that: (1) the Company lacked adequate internal controls over protocol adherence and data integrity; (2) as a result, the Company’s principal investigator failed to adhere to the informed consent form approved by the Institutional Review Board; (3) the Company’s principal investigator failed to maintain adequate case histories for certain patients whose records were reviewed by the FDA; (4) the Company’s principal investigator fabricated email correspondence with a pharmacovigilance safety vendor that was then provided to the FDA; (5) the foregoing would negatively impact the Company’s ability to obtain regulatory approval of BXCL501 for the treatment of agitation associated with dementia in patients with probable Alzheimer’s disease; and (6) as a result of the foregoing, defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.