Accelerated ApprovalThere doesn't seem to be a link between Breakthrough Therapy and Accelerated Approval. There might be, but so far, I haven't found any, in any documentation.
In the June corporate presentation, AA (projected early 2023) is also presented as being independent of Breakthrough designation. Not a post-requisite.
To qualify for AA, one has to demonstrate a surrogate point, like a marker pointing to a tumor shrinkage, as per this document:
https://reaganudall.org/sites/default/files/2022-03/RUF_drugApproval_graphic%20%28002%29.jpg Cystoscopy can confirm "
no sign of tumor", like it did for Ph. 1b p#5-6. So it's clear that we technically qualify. Could we already have applied for the AA with data on the optimized group so far (p#13-20) and be awaiting FDA response by Jan. 1st???