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Arby2000

01/05/21 12:55 PM

#344988 RE: flipper44 #344985

Sounds more and more as if they found a new way to sell tin foil hats at the expense of GBM patients. And making out like bandits doing so.
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flipper44

01/05/21 1:00 PM

#344991 RE: flipper44 #344985

What’s scarier is that NVCR created a (trick) statistical analysis template to follow.
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jammyjames

01/05/21 1:47 PM

#345017 RE: flipper44 #344985

is that what you're going to write in your letter of complaint?

check page 18, table 4. Here's a more detailed breakdown of the censors of the data used for approval. You've got fairly similar censoring % between the 2 arms. Slightly more on the optune arm for withdrawing and disease progression/AE but no where near enough to account for the differences on the KM curve between the two arms.

https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100034S013b.pdf

still this doesn't change the fact that they don't have reliable data to say anything about 5-year survival and in my opinion it shouldn't be legal for them to advertise that % KM figure.