Replies to post #219474 on Elite Pharmaceuticals Inc (ELTP)

[COO2002COO]

Practices of FDA. In case you missed the information, here is just one of them to refresh your memory:

Why is FDA adopting the use of complete response letters?

A complete response letter provides a more consistent and neutral mechanism to convey that our initial review of an application is complete and we cannot approve the application in its present form. It provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application. The adoption of complete response letters is one of the Agency’s commitments under the Prescription Drug User Fee Act (PDUFA).


http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/LawsActsandRules/ucm084143.htm

[Couch]

That is total BS.

“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.

[dr_lowenstein]

Yes it is. There are no longer not approvable letters.