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Re: MI Dendream post# 467806

Sunday, 05/08/2022 10:48:24 AM

Sunday, May 08, 2022 10:48:24 AM

Post# of 704417
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. :)
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