Elite Pharmaceuticals Inc (ELTP)

[dr_lowenstein]

The FDA, as I said before is cautious and relies on precedent. In this case, the caution arises because of the dual active even though one is theoretically not released. It also arises from the potential for formulation to affect efficacy and safety in practice. Bioavailability is an indicator. but is not 100% reliable in this context and it is a limited number of subjects and said subjects are healthy volunteers, not patients with all of the concomitant on board drugs and physiological issues that healthy volunteers do not have. If there were so straightforward this would be filed as a 505j, not as a 505b2.