Elite Pharmaceuticals Inc (ELTP)

[Couch]

No that is nothing but a crock of Sh*T. A CRL letter is not a rejection letter.

http://www.healthcarelawinsights.com/wp-content/uploads/sites/667/2015/01/CRL_Whitepaper.pdf

II. The Evolution of the Complete Response Letter

Before August 2008, the FDA responded to a drug application in one of three ways:

• Approval letter: The FDA approved the drug application and the drug could go to market. The contents of approval letters were made available to the public at a later date.

• Approvable letter: The FDA could not approve the application as submitted, but might subsequently grant approval if certain criteria were met.

• Not approvable letter: The FDA could not approve the drug application as submitted.

“Not Approvable” letters meant that the FDA had refused to allow a drug to go to market and the interaction between the FDA and the applicant on that application was completed, and if the applicant decided to continue developing that drug, when ready the process of applying for market entry would begin anew. In the instance of an approvable letter, the applicant was free to continue his efforts for subsequent drug approval by the FDA working on the criteria noted in the letter. This letter most closely resembles the current CRL process. Regardless, the type of letter had a potentially significant real-world impact on the applicant, completely separate from the application’s status with the FDA.