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hankmanhub

03/07/25 2:54 PM

#753113 RE: JFR161162 #753106

I like your logic, but I would keep in mind that this (I hope) will not be a typical labelling negotiation. I hope they will be asking for a much broader label, perhaps for not just nGBM and rGBM but also for all gliomas of any type and, dare I say, for all solid cancers on a cancer and tissue agnostic basis (perhaps with a follow up P IV). This might complicate the labelling negotiation and take a few more weeks than typical. Perhaps they may also ask for a label that does not include the current SOC such as the chemo and Temozolomide and radiology treatments - just the resection.