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Re: Know-Fear post# 161555

Thursday, 03/08/2018 12:48:35 PM

Thursday, March 08, 2018 12:48:35 PM

Post# of 721306
I've also had a change with my impression of the rGBM combination trial. I think UCLA moved it out (for the fifth time) to June 1, 2018 (apparently a pivotal date for many things), in order that their trial design can take into account any and all new information gathered from the "spring refresh." They might or might not do some last minute tinkering to the combination trial design. Of course, it appears they are also likely waiting to see topline in the phase III for obvious pragmatic reasons at this point. I'm less inclined to believe, as I once more did, that the rGBM might be used for confirmation. The continued timing delays for the combination trial seem to emphatically reject that proposition. Of course, this then can be spun either way. It could mean UCLA anticipates the phase III trial will prove ultimately fully approvable for DCVax-L on its own merits, or they have enough knowledge about their unmasked adjuvant and monotherapy armed trial that they think they already have confirmation in the bag in case it is needed, or, on the bearish side, that they don't expect much from the Phase III trial. I doubt it's the latter.

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