Replies to post #276816 on Elite Pharmaceuticals Inc (ELTP)

[namtae]

It's possible Elite plays by different set of rules than public companies in compliance

A triggering event occurring within 4 business days before the registrant's filing of a periodic report may be disclosed in that periodic report, except for filings required to be made under Item 4.01, Changes in Registrant's Certifying Accountant and Item 4.02, Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review. The registrant may disclose triggering events, other than Items 4.01 and 4.02 events, on the periodic report under Revised Item 5 of Part II of Forms 10-Q and 10-QSB and Item 9B of Form 10-K and Item 8B of Form 10-KSB, as applicable. All Item 4.01 and Item 4.02 events must be reported on Form 8-K. Of course, amendments to previously filed Forms 8-K must be filed on a Form 8-K/A.

[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.