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Re: hankmanhub post# 611478

Thursday, 07/20/2023 10:00:45 AM

Thursday, July 20, 2023 10:00:45 AM

Post# of 700462
Addition to my post:
I would add one more possibility that I missed in the original post;
2.1) to account for Poly iclc?

Thus the post now reads:

At 27 modules and 1.7 million total pages,


I assume that as 1.7 M pages is much larger the the usual submission, then it follows that 27 modules is much larger than usual as well. Anyone know how many modules the typical submission contains? If for example the answer id say 20 modules, then we have 7 extra modules. (my math is very good).
My question is, what would be the substance of these say 7 extra modules?
1) due to the diff requirements of the several RAs?
2) to account for tissue agnostic?
2.1) to account for Poly iclc?
3) to account for EDEN?
4) to account for the addition of rGBM?
5) to account for solid tumors?
6) to account for Direct?
7) to account for the many possible combos, in particular those trials already underway?
8) to treat DCVAX as a platform?
9) to account for ECA?
10) to help lead up to any of the above to ease future trials and lighten their submissions?
11) For any combination of the above?
Clearly something is happening here, even if we are only actually applying for GBM in the UK.
Any ideas?
Whatever the answer to the above we really seem to be on the one yard line this time. Can't be long now!
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