Elite Pharmaceuticals Inc (ELTP)

[Steges]

I agree 100% re: very solid chance of approval by the PDUFA date because the FDA had everything they needed in advance, the labeling of nasal and intravenous adt is obvious for this product, and the ADCOMs that just occurred only reinforces they should be all set for imminent approval.

Also, there is not such thing as an oral adt. Vantrela is not an oral adt (not sure what the committee was thinking on that one - particularly the vote being 14-3!) and I wouldn't be surprised if they all get the same nasal and intravenous adt labeling when all is said and done.