Biotech Values

[jq1234]

Each situation is different. Back and forth with FDA on potential filing is nothing unusual. It usually happens in the background though while this one is in public. It is good it would be a define yes or no answer from FDA to avoid RTF like Genetech T-DM1 accelerated approval filing.

This is pretty much what I expected that AA filing would be around surrogate endpoint and likelihood of surrogate endpoint to predict clinical endpoint 6MWT.