Elite Pharmaceuticals Inc (ELTP)

[Hike]

All clinical trials in the U.S. must be approved by an IRB (Institutional Review Board) before they begin so if commercial batches are considered part of the Phase 3 trial (not sure of that) then I imagine they would need the FDA's OK.

Also, for cgmp there is a LOT of reporting (mostly statistical reports on manufacturing/variations etc) that are done and I believe that that QC process etc has to be thoroughly documented and approved before physical batches are made etc.

Whether that level of data is available to the consumer/investor I don't know.

I'll keep poking around on that.