On July 20 & 25 I posted the following:
hankmanhub
Re: Doc logic post# 613686
Tuesday, July 25, 2023 4:46:07 PM
Post#
613710
of 623388
On the 19th I posted several thoughts on the possibilities for the additional modules (pages) which I copied below. I have inserted into your post the correspondence to my item numbers from my post, Seems like the ideas are pretty similar except I offered more choices.
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To tell you the truth there are a few things that 700,000 extra pages could be focused on. ((4)) First of all this trial started as de novo GBM then turned to GBM and rGBM. As you know GBM was reclassified based on IDH status too before results were published so plenty of things this extra paperwork could represent. ((2)) The possibilities also includes supporting evidence of tissue agnostic status due to the natural in vivo way DCs and, therefore, DCVax works through the imitation of the process of DC maturation/activation and subsequent immune response in almost ALL DISEASES. ((2.1)) Then there is the use of Poly ICLC as an activator of increased immune response ((3)) and digitization of Edens which will be the answer, at least on an early interim basis, for getting a personalized vaccine treatment to the masses of patients wanting and needing them. Take your pick, they are all good choices.
hankmanhub
07/20/23 10:00 AM
#611917 RE: hankmanhub #611478
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!
