ANI Pharmaceuticals (ANIP)

[silvr_surfr]

Hmm, I look at the classic version of the clinical trials page and it does not have this comment, so I cannot confirm that it is new. I looked at the rules again, and we can say for certainty that it is delayed for one of the below three reasons (perhaps the second reason does not even apply):

Certify Initial Approval: Trial studies an FDA-regulated drug product (including a biological product) or device product that was not approved, licensed or cleared by FDA for any use before the Primary Completion Date of the trial, and the sponsor intends to continue with product development and is either seeking, or may at a future date seek, FDA approval, licensure, or clearance of the drug product (including a biological product) or device product under study.

Certify New Use: Trial studies an FDA-regulated drug product (including a biological product) or device product that previously has been approved, licensed, or cleared, for which the manufacturer is the sponsor of the trial and for which an application or premarket notification seeking approval, licensure, or clearance of the use being studied (which is not included in the labeling of the approved, licensed, or cleared drug, product (including a biologic product) or device product) has been filed or will be filed within one year with FDA.

Extension: Request, for good cause, an extension of the deadline for submitting results information.

Could we FOIA this and find out what the delay reason was?