Thumbs Up. Thumbs Down: On rookie mistakes, a class action suit and getting past failure
Endpoints assesses the big biopharma R&D stories of the week, with a little added commentary on what they mean for the industry.
Portola makes a rookie mistake, and gets hammered by a CRL
If any company looked to be sitting in the right place at the right time with a new drug application, it was Portola. The FDA had already given the company a breakthrough designation, offering ready access that company execs say they took advantage of regularly. But when it came down to the PDUFA date, the biotech was forced to announce that the agency had rejected the application. Why? In a call with analysts, Portola’s crew sounded like they had fundamentally misjudged the FDA’s attitude on manufacturing and data issues. Points they thought could have been clarified after an approval couldn’t wait. And now it will spend some time answering the FDA’s CRL rather than marketing its anti-anticoagulant. This was a simple rookie mistake, but we’ve seen repeated rejections this year based on CMC issues. Other developers should take very careful note of it.
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