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Re: marzan post# 625751

Tuesday, 08/29/2023 8:46:32 AM

Tuesday, August 29, 2023 8:46:32 AM

Post# of 730653
marzan,

Thanks. I am just a minnow swimming along with many whales.

One thing I feel really interesting is McKensson's unique expertise in using real world evidence to file for FDA approval.

A powerful, real-world evidence study designed by McKesson Specialty Health for its biopharma partner played a key role in the Food and Drug Administration’s (FDA) approval for first-line indication for a rare disease. Recently “Merkel Cell Carcinoma Observational Study for Historic Comparison” received the 2018 Clinical and Research Excellence (CARE) Award for Best in Health Economics and Outcomes Research, recognizing how data research supports true innovation in oncology care.



McKensson has Ontada and Aetion purely oriented for RWE (real world evidence). Dr. Vivek Subbiah is a big champion of using RWE for regulatory approval.

https://www.businesswire.com/news/home/20210519005219/en/

The longs here are worried about the trials that NWBO is planning to carry out will take another five years or longer. My speculation is that this won't happen. NWBO is going to use real world evidence for regulatory approval. That's what NWBO is going to do in the next stage. We will see pretty soon what "revolutionize cancer clinical research" means. Hopefully in a couple of months.

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