Monday, July 10, 2017 11:46:53 AM
Reuters
The keenly anticipated preliminary review of the leukemia treatment, posted on the FDA's website on Monday, comes two days ahead of the advisory panel meeting, which will discuss the drug and vote on whether the benefits exceed the risks.
If approved, the drug would be first gene therapy to be approved in the United States. The FDA is not obliged to follow the recommendations of its advisors but typically does so.
(OXB has been mentioned in the New York Times, FT I think things are looking up.)
HTTP://www.reuters.com/article/us-novartis-leukemia-fda-idUSKBN19V1GF
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