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Biotech / Medical : ABTI Alpha-Beta Technology

ABTI 0.200

+99,900.0%

Jun 17 12:34 PM EST

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To: Eduardo Canto who wrote (352)	7/31/1997 10:32:00 PM
From: Cacaito	of 572

Eduardo Canto: Your 98% chance of working is not real, not even for simple translation of results. Do not forget that those results came after combining groups that were not initially in the plan, this is very important to interpret P. There is nothing about the POWER of the study. This is probably well below 50%(this means nothing) because of the very few number of patients. The phase III study must use a power of at least 80% and must be planned in advance.The study can not be run the same way as phase II. It must be very strict in patient recruitment and similarity of clinical conditions. Many times the care of this patients is above the usual for non research conditions and it is harder to prove a benefit. Because the patient care is so good,infections and complications are decreased across the board. Something as simple as washing one's hands is strictly inforced and infections go down in both treatment and placebo groups. Recent example of this was Synergen TNF blocker, infected patients in the control group were well below the historical range (company down from $60 to $5 and then someone swallow the rests). Very recently ALLP perflubron trial was halted due to a very low mortality in placebo group (down to 10% from expected historical mortality of ards of 30% to 50%). And this is a very good product with very strong research. Recent Lipo failure was preceded by a much better organized pII study (26 patients only) and the same plague: no decrease in mortality.

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