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The ITCA 650 device. Photo: Intarcia Therapeutics
The FDA yesterday erected a new speed-bump for Intarcia Therapeutics, the Boston biotech "unicorn" that has developed a matchstick-sized implantable device for Type II diabetes treatment.
What happened: The FDA sent a Complete Response Letter that Intarcia says relates to aspects of its device manufacturing process (the letter itself was not publicly released). That means commercialization in the U.S. will be delayed from Q4 of this year to the second half of 2018. Intarcia says the CRL should not necessitate any additional clinical trials.
Why it matters, beyond for Type II diabetes patients: Intarcia CEO Kurt Graves has been the rare VC-backed biotech CEO who has insisted on commercializing before IPO, and yesterday told Axios that there is no change to that strategy. He added that the company has now raised over $615 million for its Series EE funding, which held a $215 million first close last fall at a $3.5 billion pre-money valuation. Most of the additional cash has come from sovereign wealth funds.