Can bluebird bio Recover From Another Major Setback?
Shares of bluebird bio (NASDAQ: BLUE) recently took a pounding after the company's lead candidate hit a snag that investors find all too familiar. The company will no longer be applying for approval of bb1111 as a treatment for sickle cell disease (SCD) in the second half of 2021 as previously expected. Instead, Bluebird will spend about a year proving it can manufacture commercial-grade bb1111 identical to the product used in clinical trials supporting its application.
The Food and Drug Administration's insistence on analytical comparability means an application to treat sickle cell disease patients with bb1111 won't be ready for review until late 2022 at the earliest.
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Source Fool.com
