Deadline
Passed
Lead Plaintiff Deadline: February 08, 2021
(i) the truth about the feedback received from the FDA concerning the “end-of-Phase 2” meeting; (ii) the Phase 2b study did not use the commercial formulation of roluperidone and was conducted solely outside of the United States; (iii) the failure of the Phase 3 study to meet its primary and key secondary endpoints rendered that study incapable of supporting substantial evidence of effectiveness; (iv) the Company’s plan to use the combination of the Phase 2b and Phase 3 studies would be “highly unlikely” to support the submission of an NDA; (v) reliance on these two trials in the submission of an NDA would lead to “substantial review issues” because the trials were inadequate and not well-controlled; and (vi) as a result, the Company’s public statements were materially false and misleading at all relevant times.