Talon Therapeutics Inc (fka TLON)

[goodwill4all]

"We have corrected flaws in vincristine ... Our doses are two to three times larger," said Talon Chief Executive Steven Deitcher in an interview. "We can dose intensify with a side effect profile comparable to the original drug."

This is the basis for my dosing comments. The FDA may agree with how the study was powered, but clearly they are looking for more information on something. I can only say in my experience what that ususally means in labeling negotiations.