I've touched on this a few times now some are putting a little too much merit to the OLE. Still trying to find approval vs non- approval for confirmation, but OLE basically means you completed a trial and it doesn't appear the drug was harmful.

"n summary, OLE studies, despite being a standard addition to many well-controlled studies, need to be examined much more carefully to determine whether they are statistically meaningful and ethical. If OLE studies do not provide clinical insight or (more cynically) are done simply to get clinical sites accustomed to providing the new treatment in anticipation of regulatory approval, then this clearly is a problem that needs to be addressed."

https://www.appliedclinicaltrialsonline.com/v...on-studies