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FDA subsequently concluded that evidence supporting TB-500 itself for wound healing remained insufficient

4: Hahn, A., Wolters, M

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Doses in research trials have ranged up to 2 mg per kg of body weight per day (max ~50 mg/day) to achieve therapeutic effects [5]

While we continue to believe in the validity and importance of this measure, and the clinical significance of measuring radiation safety, we acknowledge the current challenges that HOPDs face with respect to the measure's implementation that could necessitate a longer implementation timeframe