Canadian drugmaker Thallion Pharmaceuticals and the FDA have agreed on a regulatory framework for Shigamabs, a treatment of Shigatoxin-mediated E. coli infections.

The new framework will allow the firm to include U.S. sites in an upcoming Phase II/III study, Thallion said.
 
The company announced in October that it intended to proceed with the trial outside the U.S. because of the lack of a clear regulatory path.