Biotime-Nasdaq's best kept secret? Message Board

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Biotech / Medical : Biotime-Nasdaq's best kept secret?

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Nov 5 1:26 PM EST

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To: mesaone who wrote (1232)	12/10/1998 11:57:00 PM
From: mesaone	Read Replies (1) of 1432

Homeboy says: <<And without an organized prospective randomized double-blind clinical trial including a significant number of patients, it is highly unlikely that the FDA will accept Biotime's conclusion that the calcium in Hextend actually reduces bleeding and improves coagulation.>> And this is why I know you are NBIC or one of his stablemates (Manuel's hired goons?). You keep coming up with this bizarre notion that the FDA has to buy into this calcium thing and swallow BTIM's "retrospective subgroup analysis and data dredging" to find Hextend approvable. Again, the phase III trial (yes, "an organized prospective randomized double-blind clinical trial including a significant number of patients") was designed to demonstrate Hextend's safety and efficacy equivalence to the gold standard, hespan. Superiority to hespan was never an FDA requirement for approvabilty. But the study in fact did demonstrate statistically significant safety (bleeding complications) and efficacy (clinically significant hemodynamic parameters) superiority to hespan with standard statistical analysis and without subgroup analysis or "data dredging" and without requiring a complete understanding of all the complex physiologic mechanisms that may or may not be at play in order to explain Hextend's superiority. Deal with it! And please consider asking Manuel to transfer you to the CCSI case. A transcutaneous bilirubinometer that will revolutionize pediatric medicine? ;-) You'll likely find a more receptive audience for your insidious pseudo-intellectual distortion of facts and issues and your slanderous unfounded attacks of company management and scientists. Your act here has grown quite stale. Have a nice day.

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