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Re: ATLnsider post# 603046

Tuesday, 06/20/2023 10:47:39 AM

Tuesday, June 20, 2023 10:47:39 AM

Post# of 822036
I agree with you that they have a tissue agnostic treatment and I believe that there will be expedited ways to get approval for new indications including that it is tissue agnostic. But, I do not believe they are in a position to get tissue agnostic approval for a Glioblastoma trial on first application.

Subsequently, they may have relevant data and may go through the relevant process for a tissue agnostic application. And real world data might even be usable if it fits the necessary criteria.

But I doubt they would skip the GBM application and I doubt they even can do so in terms of approval routes to jump immediately to a Tissue Agnostic approval based on side data, or just the formal Glioblastoma trial. Plus that just doesn’t fit how this process works. But I do believe and expect that many will want DCVax-L off-label, and that will be easier to get as well as insurance and Medicare/Medicaid coverage.
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