Elite Pharmaceuticals Inc (ELTP)

[dr_lowenstein]

Yes, they could, but in this case that is NOT what they did- otherwise they would not describe it as immediate release. By the way I have never been convinced that the first product would be Morphine. Nasrat believed he would not have to do an efficacy study and that was only even theoretically possible with an IR Oxy product. It would be theoretically possible to argue for approval if they had bioequivalence. HOWEVER, the thorn in the side was the combination product issue - hence as I predicted the need for efficacy. The other interesting thing is that the efficacy study needed is for acute administration following surgery and not chronic pain, where again the bulk of the market lies. Not a terrible strategy but certainly nit the billions and billion predicted