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hoffmann6383

04/25/22 10:53 AM

#462570 RE: ATLnsider #462560

great post and info atlnsider
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Nix59

04/25/22 11:04 AM

#462573 RE: ATLnsider #462560

Great post!!!! Keep them coming!
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Margin Buu

04/25/22 11:41 AM

#462580 RE: ATLnsider #462560

It's all there, black and white, clear as crystal!
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pqr

04/25/22 11:48 AM

#462581 RE: ATLnsider #462560

ATL excellent thank you.
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sukus

04/25/22 11:54 AM

#462583 RE: ATLnsider #462560

Agree 100% ATL.
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sentiment_stocks

04/25/22 12:40 PM

#462592 RE: ATLnsider #462560

They say that DCVax-L will not be approved to treat those subsets of trial patients who had OS increases to 18, 24, 30, 36, 42, 48, and 54 months, compared to the current OS for SOC to treat ndGBM, which is currently only 14 to 16 months.



Hmm... it would be very interesting, then, if the subset who did better was comprised of those in the treatment arm.

Great post, by the way.

:)
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Hopeforthefuture3

04/25/22 1:37 PM

#462612 RE: ATLnsider #462560

ATL, wish you were correct but I go with what Dr. Liau has said at her presentations before she got talking about the combination therapy trial. Imo these trials started as her group is seeking a way to help a greater % of patients.
Not my problem if you are having difficulty understanding what she says, it does in some presentations mix what they are actually seeing and ideas on how they may try to improve the percentages
Good luck
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MI Dendream

04/25/22 7:13 PM

#462668 RE: ATLnsider #462560

Dr.Richard Pazdur, Head of Oncology Center of Excellence - FDA 17:57

“Really, we don’t work for the regulations. We work for the US Govt and the US Govt are the patients, they are the community. And we have to always remember that we are not the American Statistical Association making decisions based on a P value. We have to weigh the risks and benefits of every application and every decision about what is in the best interest of the patients. And I always tell our staff that that should be our ultimate decision here. Is what is in the best interest of the patient in making a regulatory decision.

And if you keep that in mind, you will always be on the right side of history.”

https://collaboration.fda.gov/pbq6126oijaa/

I know that I am on the right side of history here. The question to ask yourselves is are you?

Thanks for the video ATL!

BTW - Pazdur hails from Chicago. A fitting place to make history
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abc1212

04/25/22 10:12 PM

#462703 RE: ATLnsider #462560

Very interesting post ATL, many thanks