Biotech Values

[DewDiligence]

Roche/IMGN—FDA issues Refusal-to-File letter for accelerated approval of T-DM1:

http://finance.yahoo.com/news/Genentech-Provides-Update-on-bw-3922842210.html?x=0&.v=1

In its review of the BLA, the FDA stated the T-DM1 trials did not meet the standard for accelerated approval because all available treatment choices approved for metastatic breast cancer, regardless of HER2 status, had not been exhausted in the study population.