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Biotech / Medical : IPIC
IPIC 0.00010000.0%Aug 15 3:35 PM EST
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To: David D. Long who wrote ()5/6/1998 10:47:00 PM
From: muddphudd   of 1359
 
This is a clipped from a post on Yahoo:IPIC by NeuroInvest

An interesting update regarding the CerAxon MRI trial. The initial release from the company had implied a complete washout of the trial due to the unforeseen high placebo response. However, a fuller analysis of the MRI findings were presented at the American Academy of Neurology last week, and the direction of the results (not statistically significant) were supportive of effect on CerAxon's part, even though a total of only 81 patients completed the full three months of the study.

Specifically, the mean infarct volume (i.e. volume of stroke damaged brain tissue) for placebo patients increased by 180% over three months. The mean infarct volume for patients receiving CerAxon increased by only 38%. Since there was a negative correlation between infarct size and functional outcome,a positive effect upon neuro function is implied.

Because of the variance in the populations, and the very small sample size, this did not reach statistical significance, nor did it reach the level of p<.10 where it is considered acceptable to discuss statistical trends. Because the FDA had made it clear that it would accept nothing less than statistical significance, the NDA was withdrawn.

This supports what we have said before...that this trial did not reflect a failure of the drug...and it continues to be a mark of bureaucratic intransigence that the FDA is primarily attuned to statistical nit-picking rather than what is a consistent pattern of demonstrated clinical value on CerAxon's part. NeuroInvestment (www.neuroinv.com)
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