Elite Pharmaceuticals Inc (ELTP)

[rrr2003]

I really need to add some additional information to your list:

FDA meeting(s) - yes they did occur in 2014 and 2015
NDA by end 2014 - September/2014 NDA was on track to be filed by year end. November/2014 the FDA advised a PIII may now required. We will let you know in due course. An FDA decision was finally rendered early 2015 prompting an PIII efficacy trial.
No P3 needed - absolute BS. November/2014, Nasrat was advised by the FDA a PIII trial may be required- see comments above.
NDA by end 2015 (notice a recurring theme?)- ELI-200 NDA was filed on January 14/2016. Wow, Nasrat missed the year end filing by two whole weeks.
resolution of Safety issue any day now - "any day now" - when did he say this?


LOL LOL