hopeforthefuture2, I understand your frustration. Like many, I was disappointed that no more progress was reported at ASCO 2018.
However, looking back at it now I feel that the progress made between the November 2018 SNO and ASCO was still substantial. The SAP was worked on for 5 months and was almost complete and queries were reduced from thousands to a few hundred.
It is true that those few hundred queries may be the most difficult to answer but NWBO told us that they are mostly uncertain about the time it would take for the RAs to submit their approval of the SAP, which means they are relatively more confident that they can complete the SAP and answer the queries within a reasonable time. NWBO has signaled that approval of the SAP by the 4 RAs may take more time than anything else. However I am guessing that this too can be done within the next 2 months.
I also believe that given the very few new OS events that are likely to have occurred recently, the number of additional queries most likely should not represent a problem.
In summary I also tend to believe that the SAP has already been dispatched to the RAs and that top line is possible by September.
I don't believe that if the trial is successful, it will take the FDA as long as one year to approve DCVax-L. The need for treatment of GBM patients is too important for the FDA to drag its feet. This is just my hunch, but if the trial shows great promise, the UK. EU and Canada will be swift in submitting their approval and the FDA probably would not want to be far behind.
