Purushothaman Damodara Kumaran, M.D. / Senthil Specialty Hospital

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60].

Passage 2

You failed to adhere to these requirements. Specifically, for Subjects **(b)(6)**, and **(b)(6)**, hematology and pulmonary function safety assessments were not completed after investigational drug dosing on Day 8, Day 22, and Day 35 during both Period I and Period II, as required by the protocol. As a result, half of the protocol-required safety assessments for these subjects were not completed during the study.