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biosectinvestor

08/22/20 8:18 PM

#301612 RE: JerryCampbell #301605

No, given the 90% crossover and the halt that seems to have only protected them ultimately from enrolling more placebo patients, and then the unexpected FDA guidance update allowing historic SOC data to be used, along with recent approvals without placebo patients based upon overwhelming evidence and high need for particularly deadly diseases, the only way we get to your destination is with a time travel machine and by excluding reforms and advancements in how trials are run and judged.

You have to step backwards and ignore many facts and developments to get to your destination, but it sounds good to newbies and the less sophisticated.
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CherryTree1

08/23/20 8:00 AM

#301655 RE: JerryCampbell #301605

That is certainly true if you are trying to demonstrate that some new chemo treatment has a median overall survival that is 1 or 2 or 4 months better than the current SOC but in case pretty much every GBM patient is dead after 5 years with the SOC treatment whereas we are seeing with DCVAX > 20% are still alive and much higher % still alive if you look at subgroup or methylation. You would be igoring commonsense to say well here is the treatment group and here is the placebo group most of which 90% ended up crossing over and getting DCVAX. If the placebo group also benefited from receiving DCVAX perhaps even just a much even receiving it a little later after progression it would be ludicrous to ignore that. If you were diagnosed with GBM what would you choose as a treatment SOC or DCVAX with what you know now?
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hankmanhub

08/23/20 12:42 PM

#301703 RE: JerryCampbell #301605

If the control cohort and treatment cohort both lived longer than expected, then nwbo is back to square zero.



Why would you choose to propose that this SOC will be any different than any previous SOC? If you are questioning the selection procedures then you can make similar claims with ALL blinded trials. The only logical assumption is that the only significant difference between the treatment in the arms was whether they received DCVAX or not - and this would be the logical reason to assume a different result for the two arms rather than assume illogically that the two arms will show no difference and for some strange reason the SOC lived much longer than any other previous SOC!