After 2 damning CRLs and 3 denied dispute-resolution requests, an ailing, one-time unicorn has only a glimmer of hope left with the FDA
Back in September 2017, the FDA issued its first complete response letter (CRL) for Intarcia Therapeutics’ lead, type 2 diabetes drug, calling on the company — the FDA now says — to address extensive clinical deficiencies, and device and product quality-related issues.
At the time of the CRL, however, the company said in a statement that it did not expect to be ordered to conduct “new pivotal trials or any long lead-time CMC activities.”
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