georgebailey,
MHRA and the UK have an opportunity in their hands right now like none presented to them in recent times. They can make their mark as world leaders in health care in one fell swoop with the opportunity presented to them with DCVax-L by NWBO. I do not think this opportunity is going to be ignored and the silence by MHRA with regard to flipper44’s questions seems in line with this consideration. It would be considered impossible by historical standards and a long shot as currently in process this way so should be considered unlikely even if highly desirable.
I felt like March might be the time for NWBO to announce an ASM based on progress with submission by that time but if still in progress they may be advised to avoid a meeting and any possibility of saying something they shouldn’t. If silence needs to be maintained then July-August may be the next best guess but that just seems too far out without any news especially since someone might feel the need to put pressure on NWBO by forcing a court ordered ASM because of pressure on the share price. The eery quietness of our qualified investor class tells me there might be some imminent news but this is no guarantee since all of us longs are waiting for at least the minimum regulator review time anyway so really not much to say.
As far as Edens, I have expected that process to be ready at least by FDA approval. So much time has elapsed that it may have been part of the submission and you are correct, the manufacturing plays a huge part in everything going forward with partnerships, trials and Advent ability to supply an all comers type of potential demand from GBM, rGBM, lower grade gliomas, clinical trials with combos done in Europe, off label use and medical tourism demand. Edens would seem to be a necessary part of the plans, at least in the very near future after initial demand begins to be absorbed. Best wishes.
