Yes, with mono treatment, the FDA I feel is not concerned. With combo treatments, in HIV, maraviroc paved the way with used with other HIV drugs, so less concern with combining the drugs. You take to common chemicals like Hydrogen Peroxide and Vinegar and you get Parecetic Acid. I assume the chemo drug used for colon cancer is different, so a new phase 1.

I can understand the FDA being concerned with say mono in HIV, because there are only drugs available. But you would think the more dangerous the issue, the more aggressive the FDA. While the FDA is requiring cydy to jump through the hoops for safety data for metastatic TNBC in phase 1, almost half of the patients with mTNBC diagnosed in January 2019 will be dead by next January 2020.