Deadline
Passed
Lead Plaintiff Deadline: May 03, 2021
(i) the data included in the Oral Paclitaxel plus Encequidar NDA presented a safety risk to patients in terms of an increase in neutropenia-related sequalae; (ii) the uncertainty over the results of the primary endpoint of objective response rate (ORR) at week 19 conducted by BICR; (iii) the BICR reconciliation and re-read process may have introduced unmeasured bias and influence on the BICR; (iv) the Company’s Phase 3 study that was used to file the NDA was inadequate and not well-conducted in a patient population with metastatic breast cancer representative of the U.S. population, such that the FDA would recommended a new such clinical trial; (v) as a result, it was foreseeable that the FDA would not approve the Company’s NDA in its current form; and (vi) as a result, the Company’s public statements were materially false and misleading at all relevant times.