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investingdog

06/22/13 8:59 PM

#129035 RE: volgoat #129004

Volgoat <<The FDA will need to re-evaluate MOS as the key and start looking at long term Survival percentages>>


You have a valid point, the problem is that would prolong the already lengthy trials. To get a good look at the late separation of KM curve it may take 2 to 3 times as long as it takes to get to 50% point.

Yes, 19 months would be great, especially if the control group is at the historical average of about 11 months for the mix of stage-III and stage-IV that were enrolled. If I remember correctly 84 patients were enrolled - small study and statistical noise can easily skew the results one way or the other.