There will always be scenarios where exceptions exist.
Potiga's main problem back than, and disconnect was the side effect profile: neuro-psychiatric symptoms, including confusion, hallucinations and psychotic symptoms, suicidal ideations.
This was not a concern too the the FDA advisory board, they felt the data was transient and not lingering beyond 7days and was dose dependant.
In this case, the FDA panel wasnted more data, and it was subsequently approved.
either way, there are no sure bets when involving speculative trading!
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