Adarsh Daswani, M.D.

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, **(b)(4)** doses were not administered to the following subjects randomized to receive **(b)(4)** and on **(b)(4)**:

Passage 3

You failed to adhere to this requirement. Specifically, IRT transactions were not conducted to obtain the randomized treatment dose for the following subjects:

Passage 4

You failed to adhere to these requirements. Specifically, Subject **(b)(6)**, randomized to **(b)(4)**, had a HemoCue Hgb of 12.6 g/dL, which was repeated and confirmed to be ≥12 g/dL (12.6 g/dL) on **(b)(6)**. However, randomized treatment dose was not held, and **(b)(4)** was administered on **(b)(6)**.