Elite Pharmaceuticals Inc (ELTP)

[Couch]

Its possible the FDA changed all their criteria at the last moment and cost Elite an FDA approval for Sequest.

Any effective way to research this??

Sure thing - when it comes to ELTP DD there is no better in the business.

So let me help you out.

The FDA did in fact change their criteria as Nasrat stated it did. All one needs to do is read this 2002 FDA guidance document to verify this fact.

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126833.pdf

But while I'm at let's add another piece of FDA research that cannot be denied. In essence, Nasrat has stated he will refile SequestOx's submission and he knows his chances of SequestOx's approval move to 74.6%.

The total approval rate jumped nearly 20% to 74.6% after companies submitted responses to the US Food and Drug Administration's (FDA) CRLs. A third round of responses brought that percentage up an additional 8.3% to 82.9%.

- See more at: http://www.raps.org/focus-online/news/news-article-view/article/1138/bio-analysis-resubmissions-after-third-round-of-fda-review-not-worth-the-effort.aspx#sthash.fZk9osaF.dpuf