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Re: DrChuck post# 19111

Thursday, 09/18/2014 1:41:47 AM

Thursday, September 18, 2014 1:41:47 AM

Post# of 690219
The FDA does not require OS as the primary endpoint; they prefer it, but several drugs have been approved using PFS.

IMUC is trying to reposition themselves after the failure of their PhII, and by implication deposition NW.

BTW, the failure of their PhII did not have to do with OS, rather it was that ICT-107 targets only 6 antigens, and only for one of the HLA subgroups (issues that DCVax does not have), but they did not restrict their PhII to patients with those characteristics. I'm sure their PhIII will fix those trial design issues, but there is high risk ICT-107 will be too little, too late by the time their PhIII finishes circa 2018/2019.
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