Adapting the SAP is something that is pretty common in biotech nowadays
For the sake of argument, let's assume your statement is true (although in reality I am highly skeptical that it is). For a company to "adapt" their SAP, what does that mean? If it means they are sticking with their originally defined primary endpoint but simply tweaking a parameter here or there then sure, that's probably not a very big deal and happens fairly often. But I don't think that's what you are talking about. By "adapting" the SAP I think you mean they are changing the originally defined primary endpoint of the trial. Correct? If so, why would they want to do such a drastic thing?
There's only one reason, and that's because they know the trial wasn't going to show efficacy for the originally defined primary endpoint. If they thought the trial was going to show efficacy for the originally defined primary endpoint, there's no way they would take the absurd risk of "adapting" the SAP. Right? I mean, this is just Common Sense 101, but some people seem to have the hardest time grasping common sense. It makes me fear for the future of our country.
Some will argue that OS is the "gold standard" of GBM/cancer trial endpoints. But if that is the case, then why didn't NWBO use OS as their primary endpoint for DCVax-L in the first place? "Adapting" to the gold standard, coincidentally at the exact same time all the PFS data became perfectly ripe, was a tacit admission that they screwed up royally and that their originally defined PFS endpoint was a failure. Otherwise, if PFS had been a success, wouldn't they have just come out and announced it? You bet they would have! Again, Common Sense 101.
I don't want to hear the lame argument that the trial is blinded and they were totally in the dark when they made the monumental decision to "adapt" the SAP. Of course the trial is "blinded" (wink, wink), but if you think they were totally in the dark when they made the decision to "adapt" the SAP I've got some other investments you might be interested in. What really, really bothers me is that they've never told shareholders what they are doing. If they know the trial failed its primary endpoint they have an obligation to disclose it, but they never have. Obviously, to do that the trial would no longer be blinded. Exactly. That is what's supposed to happen. We've seen several far more professional companies announce P3 failures in just the last few months. Funny, but those companies didn't try to "adapt" their SAPs. You aren't supposed to be able to take a scientific trial and just turn it in whole new direction mid-stream. That's bogus and it corrupts the scientific process. I would dispute your contention that doing so is "pretty common in biotech nowadays".
They've also conveniently left data out of their rosy interim releases, which is highly questionable and renders the interim releases utterly meaningless. What they are doing puts them right up to the edge of outright fraud, and it all stems from their obstinate lack of transparency. All of it has led us to the place we are now, almost 12 years into a trial trying to "adapt" the SAP and refusing to release the data because they don't want the pipe dream to end. Yesterday the IR guy told a shareholder that he's unable to say where they stand on the SAP/topline process. That's because there is no legitimate process. They are hoping this new doctor can pull off a miracle on the SAP, but that's not at all realistic. More likely, he will become a bigger part of turning this conversation away from DCVax-L and toward Direct. But in order to do that, they are going to need a whole lot more money. Can't wait to find out where that's going to come from.
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