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

To: Jim Roof who wrote (823)	4/2/1998 12:20:00 PM
From: Stephen How	Read Replies (1) \| Respond to of 1432

I don't think Hextend can exceed the hetastarch limit of 1.5 liters/day (20ml/kg/day). I don't think that the Phase III trials were designed to determine safe dosages. (I think that's what Phase II is for.) Also, I think that the maximum dosage is determined by hemodilution (anemia and dilutional coagulopathies). Part of the initial "story" for Hextend was that it could be used in larger volumes than hetastarch. I think this was based on the idea that Ca in Hextend solved the non-dilutional coagulopathies of hetastarch. Looking back, I don't see how the Phase III trials could have easily been designed to prove this. I think the EBL was actually a function more of surgical variation than non-dilutional coagulopathies. So I don't think that doctors can readily change their procedures without more study of Hextend (vs. hetastarch) for non-dilutional coagulopathies. Also, I don't know what the FDA requires for Hextend to claim a dosage higher than the hetastarch limit of 1.5 liters/day (= 20ml/kg/day). We should ask Biotime what was filed as the max dosage for Hextend in the NDA. Steve