There are a number of investors on Investor Village who are reasonably sure that results are sufficient to gain approval in a select group, what's uncertain if if results are sufficient in this trial, or if further data will be required in that group. The other thing I believe that's still under consideration is survival. It seems that even though the disease progressed in the patients who received the drug, they still were living longer after progression was seen.
As you may know, I've invested in NWBO, while their Phase 3 results in DCVax-L have not yet been released, one thing has clearly been established in the trial, pseudoprogression. It was found that patients thought to have progressed either had further surgery, or autopsy, and what was thought to be progression was actually an expanded mass of necrotic tumor which was termed pseudoprogression. Ultimately they found a way of using a variety of scans, as I understand it, to differentiate between progression and pseudoprogression in the patients in the trial. These are all glioblastoma patients, I don't know if their methods would work in others, or if in fact we have some pseudoprogression, but if patients are living longer post progression, I think it's a real possibility. In the case of NWBO, it's doubtful they'll achieve initially established goal, but their trial has a long tail and appears to have over 80 patients who've survived well over 3 years, I believe that survival data we lead to an approval regardless of what goals failed be met, I think the same may be true for IMGN.
Gary |
