The Priority Review designation is granted to drugs that may offer major advances in treatment, or provide a treatment for diseases with no adequate therapy.
The FDA has a goal of completing a Priority Review in just six months.
As a result, ThromboGenics has pulled out its current filing and will re-submit a BLA for ocriplasmin for symptomatic VMA including macular hole by April 2012. The re-submission will allow ThromboGenics to meet the pre-approval inspection timelines.
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