One would think, but one never knows until that pre-IND meeting. Please understand that the FDA is geared for vaccines and what are basically poisons. The assumption is that therapeutic levels are those dosages that kill microbes but not sufficient to kill humans. Even with inhibitors like Tamiflu the therapy is dependent on manipulating cell function so that the virus is blocked from entering, but the cell doesnt completely shut down. They aren't mentally geared for technology that only affects viruses and has no impact on the host.
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