U.S. Bioscience regulatory update

The amendment would be based on analyses of existing clinical data, both from the company’s two pivotal trials and from other studies, focusing on Ethyol’s protective effect against the cumulative renal and hematologic toxicities from cisplatin and cyclophosphamide.

"The indication is the same; the change is to summarize the entire clinical experience on Ethyol - not only the pivotal trial, but other studies," said CFO Robert Kriebel. "We’re encouraged we’re not being asked to do additional studies." ...