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Re: CherryTree1 post# 522062

Saturday, 10/15/2022 11:55:23 AM

Saturday, October 15, 2022 11:55:23 AM

Post# of 818740
The off-label use would be minimal if it does get approved.

First, the definition of the approved product will include the source of the lysate, and that will be the patients' glioblastoma tumor (maybe plus wIDH). If it is manufactured with a different tumor material, it is not the same product. Thus it is not off-label, but unapproved.

Second,, insurance and risk is a huge real world issue. That is why Specials does so little despite not being capacity constrained.

Not that we will ever know the answer.
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