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HappyLibrarian

09/24/20 8:24 AM

#310196 RE: learningcurve2020 #310193

I believe the Flask works purchase makes bad TLD less likely but yes, obviously there would be reflection from many but some shareholders would never admit it and will seek to excuse it.

CherryTree1

09/24/20 8:31 AM

#310197 RE: learningcurve2020 #310193

Well it seems all but impossible that we would have unimpressive results based on what we saw with the still blinded data.
https://nwbio.com/updated-interim-data-from-phase-3-trial-of-dcvax-l-for-glioblastoma/

Median OS From Surgery__________Survival 1 yr__Survival 2 yrs__Survival 3 yrs
2018 methylated 35.1 months________94.6%______66.6%______49.1%
2018 unmethylated 19.8 months______86.4%______32.6%______14.3%


With that said with > 90% of the patients receiving DCVAX at some point in the trial there is a risk that even the crossover patients see significant benefit so we don't see a big different between the patients that received DCVAX day 1 and those that got it later after progression. The argument that that won't be the case is that the GBM tumor cells will continue to mutate and the vaccine produced from exposure to the original resected tumor may not be as effective since the mutated cell with likely have a different antigen profile. That makes sense to me.

The other concern is that we already see federal agencies (e.g. The CDC with President Trump this week messing with the covid vaccine approval guide lines) may not play it fair and straight. That is a greater concern to me than DCVAX not proving far more effective than SOC for GBM. Big Pharma has deep pockets and deep pockets can influence and corrupt people in decision making positions. Lets hope and pray that is not the case if this really such an effective treatment that can save and restore many patient's lives. GLTU

exwannabe

09/24/20 12:04 PM

#310305 RE: learningcurve2020 #310193

LC, the true believers will believe the spinned version by LP and say the results are great despite a failure.

A few examples:

On PPHM one of the main longs (forget the name) argued that the stat sig subset should garner an approval despite the fact that overall patients did worse on the PS mab. PPHM did not even submit for approval.

On ONTY many argued that the key subset should have garnered an approval. They never even filed for approval.

On IMGN Gary argued the FDA screwed them as it was P<.05 of OS on a key subset despite the fact the company did not allocate sufficient alpha. They never even filed.

Expect the same here if LP spins a failed trial as I think is likely.