Elite Pharmaceuticals Inc (ELTP)

[Hike]

Couch, I don't understand this "risky business".

Camargo meets with the FDA several days a week no?

Elite and Camargo consulted with the FDA prior to beginning studies no?

Don't you think if the FDA even "suggested" Elite needed efficacy studies that Elite and Camargo would have conducted them?

No, Oxy is Oxy. If Elite demonstrates bioequivalancy efficacy is assumed.

From Wikipedia:

Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
Birkett (2003) defined bioequivalence by stating that, "two pharmaceutical products are bioequivalent if they are pharmaceutically equivalent and their bioavailabilities (rate and extent of availability) after administration in the same molar dose are similar to such a degree that their effects, with respect to both efficacy and safety, can be expected to be essentially the same.

So all that being said let us celebrate the great St. Patrick so famous for chasing the snakes out of Ireland!

Sláinte!