Whither Intarcia’s FDA decision?
More than two years ago, privately held biotech Intarcia Therapeutics received some of the worst news a company can get from the FDA. Instead of approving the company’s implant intended to treat type 2 diabetes, the FDA sent the company a complete response letter — basically, a rejection.
But complete response letters do allow the company to go back, fix whatever issues the regulator highlighted, and try again. That’s what Intarcia did back in October — and six months later, we’re all still waiting to see what happened this time. The PDUFA date was March 9, according to the company.
An Intarcia spokesperson did not respond to a request for comment.
But complete response letters do allow the company to go back, fix whatever issues the regulator highlighted, and try again. That’s what Intarcia did back in October — and six months later, we’re all still waiting to see what happened this time. The PDUFA date was March 9, according to the company.
An Intarcia spokesperson did not respond to a request for comment.
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