According to the November 8th PR the mTNBC BTD application has been submitted between Nov. 5th and 8th.
PR:
"VANCOUVER, Washington, Nov. 08, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"

, a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it has submitted to the U.S. Food and Drug Administration (“FDA”) an application for Breakthrough Therapy designation (“BTD”) for leronlimab as a potential treatment for mTNBC. This BTD application is based on the data analysis reported by the Company on November 3, 2021."