Intellipharmaceutics International Inc. (IPCI)

[fred198484]

I suspect an issue the company and the FDA are trying to sort out is if the blue dye is removed and the whole issue of oral and nasal are therefore removed, could the FDA just go ahead and give tentative approval for just the IV version of the drug? Does the removal of the blue dye require new testing? I would think not since it is not a chemically active ingredient, but the FDA may think differently.

If the FDA did agree to just the IV approval and the removal of the blue dye without the need for more testing, then I would expect the company to finish off its PODRAS testing and then apply PODRAS to the oral version abuse deterrence. Perhaps it would just drop trying to get nasal approval altogether.