One of the important features of the BTD is that no CRO is necessary. This simplifies approvals as there is no intermediary between the FDA and sponsor. That makes a November BDT application for NASH of the greatest importance for the health and well being of possibly 100 million Americans and CYDY. Patients treated for Nash with Leronlimab would simultaneously benefit from its other healing effects, known or unknown. This could make Leronlimab available by January 2022 for many millions of Americans.