JerryCampbell,
Let me put a couple of thoughts together to help explain. There had to be a good reason that NWBO thought they could expand the inclusion/exclusion requirements without damaging their chances at trial success. I think we can agree about that with Dr. Linda Liau involved. We also know that NWBO wanted to speed up the trial and lowered ALC count would be expected to have an adverse effect on SOC patients which would probably result in more rapid eventing, at least for SOC/placebo. I think we can agree on that too. Well suppose now that we focus on mesenchymal, meth-, lowered ALC, SOC patients. Those are really bad prognostic indicators right? Let's say we agree on that. Ok so let's suppose, just for argument's sake, that Fraunhofer "optimized" DCVax-L and that SOC was eventing sooner as perhaps expected by a little but then pseudoprogression type PFS eventing began to increase as well so that a noticeable increase in events was taking place compared to previous trial history. So NWBO does a blinded look to determine what might be going on and someone on the DSMB reports it looks like increased eventing based on old standards while NWBO suspects increased pseudoprogression all along. So NWBO passes info along to the Germans whose clinicians may have noticed this phenomenon first by reported clinical observations and NWBO, knowing German policy, imposes a voluntary hold before or around the same time as FDA. After the hold FDA then received updated data that the Germans may already have been familiar with due to where the observations originated from. FDA reviews and decides they too will not allow any more SOC/placebo into the trial because of obvious benefit associated with pseudoprogression created even in patients with low ALC. This is not necessarily speculation because low ALC was not found to be an exclusionary factor in the top 100 patients and normally it would be. This scenario is speculative but the observations from data and basic understandings of the historical impact of prognostic indicators is not. The data supports the idea that historical impact of various factors is being changed in some patients significantly. Those observations, if statistically significant, would be reason for an ethical intervention to prevent SOC/placebo patients from being further enrolled into a known worse situation.
Part of the changes made to the trial in 2014 was to closely monitor the impact of ALC on patient outcomes. I believe that close observation of this led to the hold. Now this does not mean that the entire group of patients is posting a median benefit at prescribed PFS and OS parameters designed for this trial but it points to benefit in at least some significant group of patients. So continuing the trial to distinguish any longer term benefit differences between earlier and later enrolled patients makes sense and is consistent with equivalency as you have noted. I hope that helps clear up what I think is going on. Those who think as I do and are traders or bent on some nefarious shenanigans would obviously have realized they had some time to play with against the longs since 2015's "bump in the road". That time appears to be quickly coming to an end. Best wishes.
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