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Biotech / Medical : Biotech Stock Picking for Charity - 2006 -- Ignore unavailable to you. Want to Upgrade?

To: dr.praveen who wrote (408)	6/6/2006 9:59:02 AM
From: DNA-Jock	Read Replies (1) \| Respond to of 592

Close, but no cigar. Unfortunately the Statistical Analysis Plan compares the performance of the median (of 3) blinded readers. Thus they hit the endpoint for accuracy and specificity (=avoiding false positives) but missed the endpoint for sensitivity (=avoiding false negatives) -- i.e. AI-700 will miss cases of CHD that the nuclear test would spot, according to these data. Another example of a great product delayed thanks to co-primary endpoints, IMNSHO.

To: dr.praveen who wrote (408)	6/6/2006 11:00:27 AM
From: kenhott	Read Replies (1) \| Respond to of 592

I have personally seen this product (by chance) and I agree with dna-jock about a potentially good product having trouble in the testing phase. My concerns were about safety (For instance, (1) there are millions of echos done per year and (2) nuclear works fine) and if they can get pass the FDA with their two phase 3s, as designed with e.g. N=300 to 400 each. Now they will need help at the FDA even if they hit all the endpoints of their 2nd phase 3. One concern I had was the lack of an adequate partner in the U.S. We may not see this product on market unless someone with size gets behind this product and push.