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Re: fm112 post# 2037

Sunday, 02/10/2013 8:49:36 PM

Sunday, February 10, 2013 8:49:36 PM

Post# of 5874
To be candid, I am not buying into this theory of predicting based on when the interim results will be read. Being randomized (2 to 1), double-blinded controlled study there is no way of knowing who is getting pulsed with ICT-107 peptides vs those who are not.

As everyone is getting SOC (chemo etc), there will be no physical indications related specifically to ICT-107 for any clue either. So at best 32 events (deaths) when they occur (any time now) interim analysis will kick in and I would suspect they would do autopsy to rule out safety issues. However from autopsy they might at best know trial duration of each of 32 patients and whether these autopsy reports can tell who got what is highly speculative. I would think they need to be able to know the later info to ascertain with any confidence the vaccine is working or not on many of those who are still alive.

THere is not sufficient information posted anywhere on what exactly they plan to do on the interim other than it's for safety. I really doubt they can even call out the futility of the trail at this point.

FYI, I am long and plan to add more as PI results are really impressive. And if at least 1/3 of patients (out of 102) are still alive towards end of this year, the odds of success is high.
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