Friday, November 02, 2018 7:51:49 PM
I thought it was relevant in light of the FDA 'refusing to file the application'....
'The setback likely leaves Alkermes back where it was at the beginning of the regulatory process, when the FDA initially refused to file the application and then did an about face and opened the door to a review. The company has another trial underway, but now may well be looking at a requirement to mount new, expensive and lengthy clinical trials that would likely take at least 3 years to complete'
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