Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

I think "Priority Review" is the correct term.

Not "Fast Track," which is different. Fast track gets 60 day review for cancer drugs, etc. NH has used this term, I believe, incorrectly. What he actually describes is "Priority Review," which is a 6 month review. ELI-200 qualifies for Priority Review based on FDA letter to NH; however, Priority Review is not offically-granted until after the application has been submitted. Fast Track status can be granted at any time in the process.


http://www.fda.gov/ForPatients/Approvals/Fast/ucm405405.htm

FDA informs the applicant of a Priority Review designation within 60 days of the receipt of the original BLA, NDA, or efficacy supplement.

Stay tuned underdog150, in approximately 2 months you'll get a PR that says Phase3 complete and application submitted. 1-2 months later you'll get a Priority Review PR, and 4-5 months later an FDA Approval PR. Wait till then to buy in at your own peril, IMO.