Roche, GA-101 could get first approval as early as December 2013
Roche is reporting that the FDA has accepted to grant GA-101 Breathrough Therapy Designation and its BLA a priority review based on the stage 1 data of the pivotal CLL11 trial, thus installing an action date for December 20, 2013. This is once again recognition of the highly valuable and meaningful results presented at the ASCO meeting in late May.
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