BDAZ - Thank you.
My take on the DSMB's comments about the Futillity Study results are:
"Stop the trial" your killing more than you are helping - which would be the worst thing we could possibly hear, the share holders would not have a very good day.
"Add more patients to the trial" - which would say we are at or near 25% RRR but less than 30% and we need stronger statistical significance, and there are no serious safety issues. This would be okay but would suggest that we need 1200 more patients in the trial and we would be about another year of time and burn capital. 25% RRR is still pretty awesome as that is in addition to standard of care.
And what we really want to hear
"Continue on the way you are" - which says we have 30% or more RRR and there are no serious safety issues.
I have heard in different presentations that once a positive Futility Study / Assessment has been announced for a Phase III Trial that there is better than 90% chance of the trial being completed successfully. Could you please give us your thoughts on my summation?
BKC - If you would chime in on this as well it would be appreciated.
tada