Deadline
Passed
Lead Plaintiff Deadline: September 20, 2021
(i) deficiencies existed with respect to an investigational drug product, DefenCath’s, manufacturing process and/or at the facility responsible for manufacturing DefenCath; (ii) in light of the foregoing deficiencies, the Food and Drug Administration was unlikely to approve the DefenCath new drug application for catheter-related bloodstream infections in its present form; (iii) Defendants had downplayed the true scope of the deficiencies with DefenCath’s manufacturing process and/or at the facility responsible for manufacturing DefenCath; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.