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07/01/17 11:01 PM

#124399 RE: Virgilio #124395

Okay, so? I've stated that I've been concerned about PFS for quite some time now.

Here's a portion of a post of mine from 6 months ago December 30, 2016 where I expressed my concern:

Right... Avii noted that there were 3 newly diagnosed GBM patients out of 15 that showed false progression. Because it was a P1/2 trial, and the doctors were "in a clinical setting" - as noted by Linda Liau in her 12-15 presentation - they figured it was probably progression caused by DCVax - not chemo/rad - and so they just waited and watched and guess what? It was.

But in this P3 trial, LL's point is that you can't just wait and watch.

One has to go with the outside radiologists' diagnosis. If two disagree... a third makes the call - something like that. I think both RK and flipper have made the case that while the progression can be cut and dried... there are several ways of ruling out or looking further to see if the progression is false. And it's possible there may have been some changes made to the 2013 protocol that might allow for further wriggle room.

But as I mentioned, there are several recent cases of patients posting on Facebook and Inspire that have received DCVax-L - 2 in the trial and 1 recurrent GBM patient (Kat) that have demonstrated progression, and they were told by their doctors that they were to cross over - even though the doctors did not know whether the progression was false or not. And in the case of Kat, she was told that this "progression" was quite "common" for this treatment... implying that this is a progression that occurs with DCVax... and not the progression associated with chemo/rad that for the most part was ruled out in the screening process.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=127531731



However, I've also written about how the company was having all the scans and data adjudicated before unblinding. I would suggest that they are likely doing this because of these types of concerns.
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biosectinvestor

07/02/17 10:35 AM

#124419 RE: Virgilio #124395

That's very linear of you. I don't think that will be the result, regardless of how it "sounds".