While we don’t have clinical results yet, if the results are half as good as the preclinical results, TNBC would likely qualify for Accelerated Approval (AA) based on reduced CTC levels and tumor shrinkage as secondary endpoints as misiu mentioned. I don’t want to put a date on it, but IMO if positive results, Approval will be much faster than many think.

Here is a link that discusses AA based on surrogate endpoints.

https://www.fda.gov/patients/fast-track-break...d-approval