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Dr Bala

12/08/22 3:38 PM

#545978 RE: hoffmann6383 #545976

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flipper44

12/08/22 3:47 PM

#545983 RE: hoffmann6383 #545976

Did you notice Dr. Stupp didn’t really critique the rGBM results? One of the advantages for DCVax-l in the recurrent trial is that there was no Temodar to interfere with t-cell behavior**. It also doesn’t infringe on his ego, because Temodar is not considered a salvage therapy.

In fact, DCVax-l can rehabilitate t-cell numbers and effectiveness after Temodar therapy is stopped.
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Papa9x

12/08/22 4:12 PM

#546002 RE: hoffmann6383 #545976

The egos of some in the scientific and academic world are just as great as those found in the political and financial world.
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biosectinvestor

12/08/22 4:15 PM

#546006 RE: hoffmann6383 #545976

Exactly!
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SkyLimit2022

12/08/22 4:32 PM

#546014 RE: hoffmann6383 #545976

I actually think that he does want DCVax to become SOC. He affirmed that the data reflect efficacy, but he’s just an older traditionalist and wants additional clinical data of the traditional variety. He’s not as current and evolving as Pazdur and the FDA’s OCE. He seems as though he would be uncomfortable with the RWE that the FDA is increasingly moving toward too.

There’s nothing wrong with a doctor who wishes to adhere to traditional views.

In my opinion, his article overall seems to present an argument for phase 4.

https://www.cancer.gov/publications/dictionaries/cancer-terms/def/phase-4-clinical-trial

https://www.fda.gov/about-fda/fda-organization/oncology-center-excellence

Bullish
Bullish