Correvio Pharma (NASDAQ:CORV) receives a complete response letter saying that the FDA can’t approve the NDA for Brinavess in its present form.
The FDA says the submitted data provides evidence of the treatment’s effectiveness but didn’t provide reassuring evidence of its safety.
Correvio will “need to develop an approach to select patients who are at low risk of adverse cardiovascular reactions” and “data from an additional, potentially uncontrolled, clinical study will be needed to assess Brinavess’ cardiovascular risk in the selected patient population and to support an NDA resubmission.”
CORV will meet with the FDA to discuss the design and specifics of a potential study to address the concerns.
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