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Re: Maverick0408 post# 401792

Tuesday, 09/14/2021 1:29:52 PM

Tuesday, September 14, 2021 1:29:52 PM

Post# of 700702
Maverick0408, I don't think LL alluded to this:


UK & EU accepted it last year. FDA has not been easy to convince one way or another and LL alluded to this last year


Can you share a link to that? (Not trying to create controversy with you, just I don't think that is the case).

What I think is that all of the RA's, including FDA are aligned with using historical control arm information to compare trial results, because I remember the company informing they will proceed with DL only after that alignment. Also, I believe that FDA clinicaltrials site is updated by the company as opposed to the other RA's web sites.

I think the reason for not updating the web site is because if the company did that, they would be just implying the trial was a success. And that is because we know from a press release that more than 90% of the patients received DCVax and that survival blinded information is much better than historical SOC information and control arms for the comparable trials.

To complement that, I think the company never thought the endpoint changes were going to be updated on the other RA's sites and was a surprise for them, as I think I read from someone on this board that talked to them.

For me all this is enough to be sure the trial was a success.

P.D.: Sorry if my English is not clear or has mistakes.

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