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05/08/22 10:48 AM

#467827 RE: MI Dendream #467806

Thanks MI Dendream!

Yes, it’s reasonable to think the FDA may want a post marketing commitment for recurrent GBM… you’re thinking like a phase 4 trial, right?

Still… the cross over control group was unequivocally rGBM on SOC, and there were about 70 of these patients who crossed over to. DCVax-L. So it’s also possible that may suffice. But reasonable, too, to think the FDA may grant something like AA for rGBM, and then ask for confirmation. We’ll see. :)