Here's Why Bluebird's Shares Fell Out of the Nest Today
Shares of bluebird bio (NASDAQ: BLUE) are down 14% today after releasing third-quarter earnings yesterday. It wasn't so much the earnings that investors are reacting to; for the record, the company lost $195 million on revenue of $19.3 million. Instead, investors are rightfully upset about a pushback in the timing of a potential approval for LentiGlobin as a treatment for sickle cell disease.
The Food and Drug Administration told bluebird that data from patients with sickle cell disease who have already been treated is enough to support the marketing application for LentiGlobin in sickle cell disease. With just that information, bluebird could be ready to submit its marketing application relatively soon.
But the FDA expressed concern about manufacturing the drug once it's approved. If a drugmaker doesn't use the commercial process to generate the drug used in the clinical trials -- which bluebird didn't -- then the agency typically requires the company to do a comparison of the different manufacturing processes to prove that they're equivalent.
Source Fool.com
