Biovica’s complete submission addresses the deficiencies identified by the agency on Biovica’s original application, including the feedback received from FDA during the interactive process up until
“We are glad to report that our team has worked thoroughly to provide all the remaining information that the FDA asked for. We look forward to making DiviTum®TKa available to breast cancer patients in US through our own CLIA certified lab as a 510(k)-cleared test, which we expect will happen later this year,” said
The expected outcome of the submission is either approval (clearance) or a request to submit more information.
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