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Re: flipper44 post# 238514

Monday, 08/05/2019 3:57:33 AM

Monday, August 05, 2019 3:57:33 AM

Post# of 820745

Idiocy. The FDA and Novocure people responsible for saying expected 13% alive at five years in their phase three Optune EF-14 final analysis treatment group should be sent packing. Only 12% (number = 57 out of 466) were alive at two years after the last patient’s enrollment. Only 3.4% ( number=16 of 466) had made it to five years by two years after last enrollment and most of those 16 likely were part of the 57 still alive. It’s downright criminal.


Yes, K/M curves are idiocy?

Maybe you should let the FDA, EMA, NICE, biostatisticians, clincal researchers and LL and the 65 other authors all know that.

As far as your flawed analysis. The 57 alive at EOS does not include LTFUs. Because of the design, the trial had a significant number of LTFUs past 2 years on trial. The purpose of K/M is to handle survival curves with missing data. That is what is has done.

There is a reason survival stats are presented as K/M and not all this hand waiving about "actual" numbers and alive at so long past end of enrollment. The reason is called math.

Was the DCVax-L paper "criminal" when it asserted a 12% OS at 88 months when only 1 or 2 patients lived that long? That was a K/M with far more missing data than the Optune 5 year number.





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