In Brief: Cardiovascular Diagnostics/Bayer
This article was originally published in The Gray Sheet
Executive SummaryCardiovascular Diagnostics/Bayer: Reach deal under which Cardiovascular Diagnostics (CVD) will develop a diagnostic point-of-care test for monitoring antithrombin (AT), a regulatory protein that helps control clotting activity in the body. Bayer produces Thrombate III, a concentrate of AT made from blood, which currently is approved for treating AT congenital deficiency. Under terms of the deal, CVD will obtain access to Bayer clinical trial data for Thrombate III for use in a future 510(k) submission. Bayer will have the first right of refusal to co-market Thrombate III with the POC test upon FDA clearance, "which could come sometime in 1997," CVD predicts...
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