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thebigass

04/11/08 7:30 PM

#5640 RE: ocyanblue #5637

One reason they would worry about keeping shareholder interest beyond the interim look is if IMPACT interim fails modestly but not horrifically the share price probably will suffer, and then the cost of raising money will go up.

Maybe there wasn't any new data that came their way that caused them to change to OBF, maybe something dawned on them. Have you tried to look at the 9901 data with an OBF alpha spending function? Is it possible to do so? How does it change the results?

It doesn't bother me so much that they made this change. For one as I indicated on the other board the raising of money indicates that they are confident about the drug and do not want to partner before approval. Now this change allows them to peek earlier and look at the final earlier, and without much of a penalty. Even if they changed nothing, the combined data of the 300 new trial participants gets us a large enough sample size to be confident in the pooled results. Plus, the FDA (according to mgmt) seemingly wants to see results 'consistent with' the previous trials - which is ironically vague for people who have been called statistical fascists (and that's what bugs me the most, because I can't beleive 'consistent with' is the actual standard for which IMPACT interim is being judged). And, so long as the FDA is willing to look at living longer as a reason to approve, then the FDA is being clear headed, finally, about what matters most to terminal patients.

[t]DNDN[t]