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biosectinvestor

07/14/21 1:50 PM

#389301 RE: anders2211 #389297

I appreciate that example, though this is a redefinition driven by the World Health Organization and larger scientific community defining cancers generally for study. So the FDA must ask NWBO this question before they can be licensed for this indication. The fact that it helps is ancillary. It’s requisite of the regulators to look at this data, and it appears the company anticipated that long ago and started the process of going back and collecting it from materials they had already collected.

This is not necessarily prospectively offered as data to enhance approval, but necessarily to answer an anticipated and obvious regulatory question that a regulator would necessarily ask if they are doing their job correctly.