Elite Pharmaceuticals Inc (ELTP)

[Jimmy Joe]

Phase1/2A proves Safety and Tolerability!!!!!

and that is exactly why SequestOx should have been approved. This was proven in the successful 163 person P3 Bunionectomy trial which had ZERO adverse events
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That is the whole ball of wax here. No adverse events. Zero.
Should of, would of, could of been approved. So why the sudden change from "just a labeling issue" to "safety concerns" with the present FDA administration?
This time around Elite has had the guidance from the FDA and the path forward toward approval is very positive. No more excuses
from the FDA. Enough of the stonewalling.