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attilathehunt

06/11/23 4:45 PM

#600498 RE: ATLnsider #600490

Maybe there are two separate submissions (simultaneously) so GBM is not held up due to further discussions regarding the agnostic submission.


If it is worth a shot, then to separate the two may be the best option.

biosectinvestor

06/11/23 5:39 PM

#600518 RE: ATLnsider #600490

I have no doubt that the DCVax platform will ultimately qualify as tissue agnostic. As a regulatory matter, I see no possibility that they are applying initially for anything vaguely like a tissue agnostic approval. I do think once approved for any indication, expansion of the indications is much, much easier and they may very well even use real world data for those applications.