On July 16, 2021 Kiromic BioPharma, Inc. (Nasdaq: KRBP) reported that Two INDs were submitted to the FDA in May 2021 for the first-in-human off-the-shelf allogeneic CAR-T for Solid Tumors (Press release, Kiromic, JUL 16, 2021, View Source [SID1234584912]).

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FDA returned with comments on the Company’s allogeneic CAR-T products with respect to:

— Tracing of all reagents used in manufacturing

— Flow chart of manufacturing processes

— Certificate of Analysis (COA) for the Company’s CAR-T products (allogeneic CAR-T)

The company has an FDA response taskforce, staffed with 30 yr industry veterans, working on answering the FDA comments above.

Our CMC processes are rigorous.

Our product is allogeneic gamma delta T cell manufacturing which few companies have mastered.

The company’s timeline for commencement of the dosing of its first in human clinical trial is expected to be tighter but we still plan on delivering in 3Q 2021.

June 2, 2021, Kiromic announces the closing of public offering