IMO its been the same for other portions of the trial design. Im not a statistician but it seems like we are trying the same thing with the power of the trials as well. We dont allow any error or wiggle. Had CD12 had 100 more people we may have likely hit approval numbers because the age differences most likely would have been more even. IMO its the same for LH. Why only 50 total. thats only 25 in LH arm and at that point we knew it would fill quickly. It would have taken hardly any more time to double that.
I love this damn drug and want it approved and helping people! I sure hope we get decent data with 25 people for all these biomarkers discussed. Hopefully we can find good PEs to aim for and if the P3 trial is thought 400 is enough we should do 600 especially if we know we could fill it quickly with some anecdotal storys from P2. Hopefully they are working on recruiting more sites as we speak for LH.
But i'm really just screaming at the sky because nothing i say means a dang thing other than sharing these thoughts on an internet bulletin board.
I love this damn drug and want it approved and helping people! I sure hope we get decent data with 25 people for all these biomarkers discussed. Hopefully we can find good PEs to aim for and if the P3 trial is thought 400 is enough we should do 600 especially if we know we could fill it quickly with some anecdotal storys from P2. Hopefully they are working on recruiting more sites as we speak for LH.
But i'm really just screaming at the sky because nothing i say means a dang thing other than sharing these thoughts on an internet bulletin board.
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