Replies to post #374699 on Elite Pharmaceuticals Inc (ELTP)

[imanjen13]

I was looking for Weezul's post but you beat me to the punch again. It is not easy to revive a discontinued drug and it would be odd for a company to discontinue a drug and then file to revive a discontinues drug they intend to launch in less than 6 months, the Elite contract expiration date being March 31,2023. You are indeed The King.

[kayak_wench]

You can decide to trust input from an anonymous user posts over fda websites, or you can read and interpret actual FDA documentation. I made it easy by posting a link below. From my read of it the process is not substantial, costly, or time-consuming'. It does mention the possibility of needing to submit a form as much as 2 months prior though (not very much of a delay given they plan to start marketing in Mar).

In my opinion it makes zero sense for a company to have to repeat costly tests just because they chose not to market a drug. Between the FDA documentation and common sense I choose to conclude that WeeZuhl is mistaken in his opinion.

See page 7, question 10 in the document below. It only mentions submitted notifcation forms no costly testing.
From https://www.fda.gov/media/138389/download