Elite Pharmaceuticals Inc (ELTP)

[Gman24]

A nice explanation of CRL’s here... good read..

Any uptick in the CRLs that deal with chemistry, manufacturing, and controls issues is really a function of increased focus by the agency on drug manufacturing, particularly of foreign firms,” he says. “Like anything, if you put more microscopes on a problem, you are going to find more issues.”


The agency doesn’t release CRLs publicly because of confidentiality concerns, and most companies disclose only limited details. “Whether and how a company discloses why it got its CRL really depends on the company,” Cormier says.


“Most publicly traded companies will disclose that information because they have U.S. Securities & Exchange Commission obligations to disclose material facts to their shareholders,” he says. “Small companies that often are privately held may be less likely to make public that they even got a CRL and, if they go that far, the ‘why’ behind it.”

https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=2ahUKEwj-ocT2tKvmAhUthOAKHdyPAswQFjAAegQIBRAB&url=https%3A%2F%2Fcen.acs.org%2Farticles%2F95%2Fi20%2Fcomplete-response-letter-mail-one.html&usg=AOvVaw1ghhBsx0ttSnEnvcN9wNBK