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Friday, May 31, 2019 2:08:41 PM
You mentioned in a post that in February 2017 management announced they reached the primary endpoint number (248). Do you think that date will be restated as a later date (I guess that is possible if they have clear evidence to change it) with what they have been finding about pseudo progression (that for what I understand was mistaken before as real progression) and announce something like that at ASCO or in the near future?
I do think, although I'm not sure, that reaching the February 2017 PFS was based on unadjudicated PFS events. I say this because that same press release indicated that at that time, the PR announcing this indicated that the MRI images were being checked. And that verbiage has since been dropped from the multi-month processes noted in the November 18 PR.
The process involves in-person monitoring visits to all of the 80-plus sites in four countries to review the files onsite, as well as other documentary confirmation and checking of all MRI images.
https://nwbio.com/nw-bio-announces-lifting-clinical-hold-dcvax-l-phase-iii-trial-fda-progression-free-survival-events-reached-overall-survival-events-not-yet-reached/
As for what they'll address about pseudo progression at ASCO, I don't know. I think, personally, that the topic of pseudo progression is tied into the halt so I'd think they'd have to trod carefully as to what they disclose on that subject overall, for now. IMO. I think there will come a time that they would give a much clearer explanation for it, and how they intend to deal with it, but whether that time is now or later, I just don't know.
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