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Biotech / Medical : Biotime-Nasdaq's best kept secret? -- Ignore unavailable to you. Want to Upgrade?

To: Jim Roof who wrote (938)	5/15/1998 12:26:00 AM
From: Stephen How	Read Replies (1) \| Respond to of 1432

Hextend is not designed to combat a loss or imbalance of calcium prima facie. It is designed with calcium and other electrolytes balanced to address coagulation problems. How is supplementing hetastarch with Ca++, K+, Mg++ and a buffer supposed to address hetastarch-induced coagulopathy? The coagulopathy is likely due to the large hetastarch molecules precipating clotting Factor VIII from the blood. The mechanism has been studied in depth, and there is evidence that the interaction is not dosage-dependent. Many studies find no effect of hetastarch on coagulation. One study safely applied 5 L to 4 patients in a 24h period, and 15 L to another patient in a 24h period. Ca++ is already in the blood. How is adding Ca++ to hetastarch supposed to solve a not-always-observed coagulation problem understood to be caused by interaction of the large hetastarch molecule? Despite the small sample in the Phase III trials, Hextend was favored in every category of import whether statistically significant or not. If this were simply due to sampling error then I would expect a more even, less one-sided observance of favoritism. We've debated all this before. The non-statistically significant differences were around .1 - .2 SD. How is Hextend&reg to compete in a crowded $30M/year US hetastarch market and charge a premium? Further, as Hextend&reg does not solve the potential hetastarch-induced coagulopathy problem, it will have the same standing as hetastarch as an alternative to albumin. Steve btim.dyn.ml.org