The Food and Drug Administration gets a lot of information in the marketing applications submitted by drug companies. Most of the data is routine and it's usually the clinical trial data that's the make-or-break issue for the decision. But every so often it's manufacturing issues that trip up the approval.
Unfortunately for Bristol-Myers Squibb
Welcome to the club.
Or in Lilly's case, welcome back. Lilly and partner Amylin Pharmaceuticals
The good news is these things almost always get resolved -- eventually. It's impossible to change clinical trial data, but manufacturing issues can be dealt with.
Bristol-Myers and Lilly didn't say exactly what the issue was or how long the delay might last, but the companies would be smart to get the problem wrapped up and resubmit quickly. With clinical-trial data that was good enough for approval, but not enough to knock the socks off doctors, a delay just makes clinicians more comfortable with using the drugs already on the market, like Genentech's
You better get hopping, Bristol-Myers and Lilly.
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