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News Focus
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vator

06/20/23 10:39 AM

#603049 RE: ATLnsider #603046

If there is a way to twist what you think, they will.
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biosectinvestor

06/20/23 10:47 AM

#603054 RE: ATLnsider #603046

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.
Bullish
Bullish
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ilovetech

06/20/23 11:18 AM

#603077 RE: ATLnsider #603046

ATL - What is DCVAX really? The answer to that question should easily put the agnostic argument to rest. To suggest that DCVAX is not tissue agnostic is to say Dendritic cells are synthetic, and not innate to human immunology. Moreover, the personalized extraction of dendritic cells makes the argument even stronger towards accepting DCVAX as an elegant "natural tissue agnostic treatment," which explains the safety profile of the treatment. With that said, " If not DCVAX, then what other possible candidates could be a better fit? Because if it's to difficult to name one, then why have the category in the first place? The category would just be another wasteful bureaucratic abyss imo.

ILT