Genotoxicity would have been anticipated years ago by competent management before even approaching FDA because Radiogel is targeting earlier stage 1 cancers. Likewise with controlled containment verification via direct imaging of Radiogel placement. MK not only came to FDA with neither, he wasted years resisting and foot dragging against those FDA suggestions.
Of course products targeting some life extension for late stage cancers are held to much lower standards. Patient is terminal. What harm could be done? Again, competent management would have understood that and not complained and resisted FDA holding an early cancer treatment to a much higher standard.
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