BW, I think HB was about to go down the route you suggested that he should, but deliberately chose not to go down that path (thus the hesitancy). I think he did not want to offend folks at FDA as idiots for giving us the black label. I think he wants to maintain good relationship with FDA to pave way for smooth sailing for EPIC trail and 113 approval. I think he figure that the Rx number will speak in favor of pona overtime, without any cost to his political capital. Sansana
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