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Biotech / Medical : Alliance Pharmaceutical
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To: Cacaito who wrote (512)1/10/2001 12:22:05 AM
From: Cacaito  Read Replies (1) of 548
 
Could Allp surprise and ask Fda approval of NDA for Oxygent, based on the European data alone or combine with the American data (phase II and III) showing efficacy and safety in general surgery and forgeting the cardiopulmonary bypass sector?

And later, after approval, try the cardiopulmonary bypass sector if feasible?

Cardiopulmonary bypass is full of complex clinical situations, age is very important, even few 80 year old patients (strokes as high as 60%) or patients with significant carotid artery occlusion (80% to 90% occlusion has risk in the 50% range)can eskew the data and create the "imbalance".

Tough situation to try to improve, actually one of the major improvements in some cardiac procedures has been the avoidance of cardiopulmonary bypass (almost 0% risk of strokes!).

Allp will most probably abandon the cardiopulmonary bypass market and go after the rest of the surgery market,later trying the acute bleeding situations at the emergency room
, ER is probably the biggest market of all.
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