Elite Pharmaceuticals Inc (ELTP)

[PH4RM4C3UT1C4LS]

Odds of approval are not 20%, don't know where you got that statistic, but you are misinformed.

Here is some old information, but still relevant nonetheless...

"Of those NDAs and BLAs, 281 (81%) received approval from the agency, of which 200 (71%) received approval during the first round of review. The remaining 81 submissions (29%) were approved during subsequent second, third (and beyond) submissions. Earlier studies, such as a 2012 analysis by the industry trade organization BIO, found that subsequent submissions have a far lower rate of approval. Only 1.4% of submissions made after the third round of submissions obtained approval , BIO found.

Complete response letters featured prominently in these reviews, Datamonitor found. One hundred and forty-six (42%) of all submissions received a CRL, of which 55% later obtained approval. Approximately a third of the submissions were withdrawn, while another 16% were still undergoing review by regulators."

- See more at: http://www.raps.org/focus-online/news/news-article-view/article/2761/#sthash.B2RxDB66.dpuf

The stats are even better, post 2012/13