I had not realized it as well. Shorts had said other things and directed people to subsequent studies, and adeptly misdirected people to make their critiques of DCVax-L. Mainstream journalists doing stories on GBM are misstating the reality and listening to doctors who are not telling the full story because it is not in their interest to do so. Super Steve did a great job of highlighting that point and then I looked up the details and added the journal article and clinicaltrials.gov link to show that the primary measure was in fact OS, and that the results did in fact show zero OS benefit. And yet it was approved. It is a device, and the scrutiny of devices is much less than drugs generally.
But yes, DCVax-L is very safe, virtually zero side-effects, has extended survival by itself, with a very easy regimen on patients after their initial standard of care treatment, and has a long-tail. In combination with Poly-ICLC it has shown incredible survival results. Truly incredible, and still with fantastic quality of life and low to no side-effects.
I cannot see this being not approved. I think the company has been exceptionally careful as well, given that there are obviously serious forces working diligently and non-stop to prevent this from coming to market. That is really the story, and that no journalist has yet taken up that effort and done full investigations of those involved, is really a huge journalistic miss here.
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