aidenb, I wanted to follow-up and provide the statement and link to the PR I was referencing, but didn't have time to look it up yesterday when posting from my phone.

Quote:

---

With recently granted Fast Track Designation for mTNBC, Section 561A(f)(2) of the FD&C Act, now requires leronlimab to be available within 15 days under expanded access policy for patients with serious or life-threatening illnesses

---

It's from the May 8th PR: CytoDyn Provides Updated Pre-Clinical Data Showing Leronlimab (PRO 140) Continues to Suppress Breast Cancer Metastatic Burden >98% Compared with Untreated Animals

https://www.cytodyn.com/newsroom/press-releas...ta-showing