Hi iclight. Sporadically posting/checking when there's news. None really today.
DCVax-L timeline has been extended. Basically we're told on these webcast. But it makes sense given the delays with getting Germany sites on board and recent add on of Canada. I stated all along that I believed enrollment would need to be complete before they stop the trial. I cant imagine any country accepting a halt if hardly any of their citizens were within the study. It's particularly important to go the distance if this same trial is going to be used for full fledge approval. Plus, Les did hint that enrollment wouldn't be complete until late this year/early next year at the last conference, so there's that too.
Do you think there's any chance that the original 33 patients were not part of this Ph III trial? I'm starting to believe they restarted the entire Ph III in late 2010, but that's just me. :)
As for Direct, it's clear to me they need a Ph II to build on results of Ph I. Btw, the "sickest of the sick" exclusion was added on June 27, 2014, so most of the main leg of the trial would have been enrolled at that point. But it could mean that they got healthier patients for the 4 over enrolled patients. Time will tell once the data on those patients shows up. They did make it clear that Direct needs additional injections and a closer schedule to get a more robust response. I see that going hand-in-hand with a market "happy" response.
Do you think they did the safety on all the different dose levels before the FDA released the Direct enrollment brakes? If so, then some of those higher dosage non-responsive patients likely reached their 4th vaccine by the June PR, and may have been turned away. They never did actually state how many of the 20 patients reached their 4th vaccine, only that the 9 of the 9 had reached it. I can't imagine that the enrollment timeline not too many of the 20 reached their 4th vaccine but, the safety test patients should have, and some of the 7 patients who showed disease progression in May, may have been denied their 4th vaccine. See, I do realize they paint the data in the best light, but skeptics like you usually spot these things before optimistic folks like me do. Point is, we're only told the good, we need to figure out what potential bad there is out there from the hints they reveal at these conferences. A first in man study, and the 4th vaccine was just too far to get a truly positive response from many patients. Anyway, I'm optimistic that Ph II will fix this.
I do not plan to transcribe the webcast.
