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ATLnsider

12/20/20 4:55 PM

#341088 RE: foxhound02 #341075

You missed the point of my message post. You need to read the FDA guidance for RTOR again. The FDA guidance clearly states that RTOR can be used to approve new drugs & biologics, and for add-on indications for already approved drugs & biologics. Here is an example of a new oncology drug FDA approval using RTOR:

https://www.quanticate.com/blog/real-time-oncology-review-first-drug-approval?hs_amp=true

I mentioned the Keytruda approval because of the connections between NWBio, Merck, Dr. Kevin Duffy & Keytruda. Please re-read my post, along with the FDA guidance, then get back to me.