My greatest concern is that the Board will fumble the distinction between pain relief and DMOAD and finish up with a longer path to significant revenue (an MPS deal excluded).
They need to separate the two in discussions with the FDA; so that an early pain and relief option is available. Otherwise the FDA may steer them to the all-encompassing labeling. We know from experience that the FDA likes to add little bits of work and we know that cycle added 9 months.
Ann: Investor Presentation - $66m Capital Raise, page-63
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