Genentech receives FDA Refuse to File Letter for T-DM1

Or, it could mean that Genentech was given faulty guidance on the early application and then the FDA backtracked. It could also mean that the FDA didn't like how Avastin played out and is now making sure they don't approve a drug and need to backtrack on it so it sounds like it could be a purely political move by the FDA. Wouldn't be the first time. I hope the breast cancer groups scream loudly on this one, they need to on behalf of the patients. Unfortunately, the way oncology clinical trials are designed, based on FDA guidance and regulations, death is the primary endpoint with the better, more effective drugs often taking longer to approve because they WORK. Talk about bitter irony!