Elite Pharmaceuticals Inc (ELTP)

[Gman24]

FYI......CRL’s

What to look for
Familiarity with the ins and outs of these letters can help you make better investing decisions. The most important thing you want to look for when a company announces the receipt of a complete response letter is the list of deficiencies cited by the FDA. The agency rarely outright rejects an application it has officially accepted and agreed to review. Instead, it uses complete response letters to cite issues that must be addressed before it will review the application again.

In 2016 the number of complete response letters issued spiked to a three-year high, largely due to increased concerns related to manufacturing facilities.

Complete response letter disclosure requirements

Perhaps the most important thing to bear in mind about complete response letters is the way companies are required to share their contents. Failure to inform shareholders about receiving one of these letters while awaiting an approval decision would most likely result in shareholder litigation, but their specific details are not subject to full disclosure.