Elite Pharmaceuticals Inc (ELTP)

[mrwrn2010]

Examples just looking around at other pharmas like Hikma and whoever Roxane is - other pharmas that received FDA approval letters dealing with first-to-file situations:

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202090Orig1s000ltredt.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208339Orig1s000ltr.pdf

Looks like if patents are involved, the FDA mentions them and discusses how the company corresponded, such as if the applicant says they were invalidated or whatnot.

Case in point: I don’t think we’ll know if we are first-to-file on the Oxy ANDA until our approval letter or if we hear of another pharma getting it before then.