As noted and I can confirm, the enrollment escalated in the second half of '16... the overwhelming majority of patients were enrolled after June of '16... kind of an escalating level of enrollment up to the end of '16.
I believe the FDA wants to improve VB111. We know from numerous points of data in various conditions that VB111 is safe. We know there is virtually nothing useful against rGBM, so the field is wide open.
One of the things that gives me pause is where Dror, in various calls, notes that a formal meta analysis of multiple trials in over 600 patients gives about an 8 month overall survival for Avastin. That is true, but if you dig into the actual trials mentioned--you get a wide range of months for overall survival from 7 up to 10.5, so there is a range of numbers for these trials. If the Avastin group survives on average 7.5 months that is one thing--but 10.5 is quite another. Since there was no selection bias in the GLOBES trial, one would be surprised to see a large Avastin number--but my point is that the number jumps around quite a bit depending on the trial noted. So you can't put too much emphasis on 8 months for Avastin and that never deviates; it does.
Another thing that bothered me(a bit)when reviewing the Inspire threads it that I found a patient or two who had stable disease on MRI--but were feeling awful(i.e. doing poorly in a subjective sense)and contemplated quitting the trial because that had to fly to center x or y in order to receive VB111. In the phase II trial, I doubt patient had to fly anywhere. This is a small point to be sure, but I'm just throwing it out there.
I found about 11-12 patients who received VB111 from the various social threads when I was invested and my "feel" was that the overall survival was not 14-15 months in this cluster--but was much less. That is only 10 % of patients but I got a feel that the final results might be close compared to the historical Avastin controls. Then I found a few drop outs from the Avastin arms as was noted on the conference calls. So, I don't think this is a slam dunk, and I don't feel that the 8 months survivorship for Avastin is set in stone. I do think there will be a tail of longer surviving patients in the VB111 and this should be enough to approve the drug. As a neurologist and former shareholder, I'm cautiously optimistic about VB111 but have not bought back in to date. Good luck to all longs--and more important to the patients. If it were up to me, I'd approve the drug just based on a tail of long term survivors alone. That should be enough IMHO.
