Elite Pharmaceuticals Inc (ELTP)

[no2koolaid]

Actually...this is a mistaken application of the facts...

The deal was for one country and one country only

THE DEAL WAS WITH ONE COMPANY, FOR ACCESS TO MULTIPLE COUNTRIES, as Dexcel's commercialization capabilities allow. Remember? One submission to EMA gets reviewed and decided upon within 210 days and then the commercialization begins across multiple countries in Europe.

pproval by EMA takes place by using a centralized procedure that leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway.

This time next year Elite will be bringing in European commercialization revenues because the approval process for generics in the EU EMA is no more difficult than for the US FDA. If approved as a generic in the US it will get approved by the EU and, in no small part, because Dexcel will be part of the process and they know the EMA. Remember, I just wrote generics not NDA's. So, please, no nonsense about some NDA that was not approved. I know there are a number that have not been approved.