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Re: hoffmann6383 post# 545976

Thursday, 12/08/2022 4:32:36 PM

Thursday, December 08, 2022 4:32:36 PM

Post# of 703805
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

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