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Re: DewDiligence post# 47829

Friday, 06/01/2007 9:39:51 AM

Friday, June 01, 2007 9:39:51 AM

Post# of 252588
How would spending more money on this trial have helped?

first of all the assumption they made going into the trial was that they would get a placebo rate of 25 percent because that has been the historical response.

the cerovive trial had 35 percent placebo rate and that trial ended before this one did. they should have asked the FDA to extend the amount of people the trial because maybe in the last couple of years standard of care has changed.

Paion did reperfusion studies in their prior trials that showed that the clot dissolved within 15 minutes to 30 minutes from the drug infusion.

If you are scratching you head trying to determine if the drug worked that data would have helped. Forest didn't do the reperfusion analysis to save money.

That wouldn't have changed the trial result but it would have answered the question about whether the drug is effective. If you can dissolve the clot within 15 minutes to a half hour that is the most you can hope for. No drug could do better without causing hemmoraghes

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