Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

It does not fit at all.

How does this fit in with this topic

http://www.cytodyn.com/media/press-releases/detail/205/cytodyn-submits-phase-3-protocol-to-fda-after-agreement-on

The Company believes that upon successful completion of this Phase 3 study, CytoDyn will have the opportunity to seek accelerated approval for PRO 140 based on previously FDA granted fast-track candidate designation.

The drug to which you are referring has FDA "Fast-Track" status and therefore irrelevant to this discussion re: FDA approval process for non-fast track drugs. As has been discussed, FDA answers questions from companies regarding their protocols. It may give an affirmative or negative answer to a specific question about a protocol, but it does not approve or dis-approve of said protocols, except in special circumstances, such as SPA. Besides accelerated review at end of Phase 3, "Fast Track" status also gives a company priority for meetings with FDA and for getting answers from them after those meetings. CytoDyn is rightly hawking their communcations with FDA and their fast track status. It's a strategy.

It seems as if the CytoDyn Investor Relations Team has a reasonable understanding of the FDA approval process and the difference between "Fast Track" and "Priority Review," as well as the potential benefit of an occasional well-timed Good News PR. Oh, to dream...