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Re: Protector post# 107041

Wednesday, 01/09/2013 12:44:40 PM

Wednesday, January 09, 2013 12:44:40 PM

Post# of 345997

- MOS after discrepancy adjustment is still super good (70% vs 100% improvement.


Why? If all one did was take the Sep data and combine the placebo + 1mg arm one would be left with an improvement in median OS of about 30% (as a quick estimate). Yes, there will be a few more datapoints comming in, but hard to see that much improvement.

- I don't see why an AA/FT/Breaktrough would be out of the equation. If any, than it will probably be the statsig of 3mg that could be the game breaker and force FDA to set the AA/FF/BT grants aside for this trial.


Stat sig seams quite unlikely. The Sep data was not stat sig for 3mg vs placebo, Adding more data points that trend the wrong way will not help.

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