Problem with the FDA, anything is possible. All biotech are at their mercy. Even this 75 days limit is based on assumption they would not find a missing comma or full stop in the final submission.
Ultimately, I dare bet it would drop just when we least expect it.
On the flip side, once the FDA lands, it becomes a barrier to entry for others. PCK approval would become the standard that future comers need to overcome to be approved. In that time, PCK will enjoy a monopoly on digital pain management system.
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