Ann: IND QUESTIONS RECEIVED FROM US FDA, page-339

Agreed, we will be informed when it is submitted/received. I know it hasn't through understanding the FDA's process and using some common sense.

"Paradigm has made the first major submission for its Pivotal study in subjects with pain associated with Knee Osteoarthritis (OA) with the submission of its IND application to the US Food and Drug Administration (FDA)."

Says nothing about it being received by the FDA. Also, it is 2021, they are not going to be making the submission via carrier pigeon, an email is effectively received immediately, so there is realistically little difference between the two, however, we will get an update once they email it to them.

Here is two excerpts from an FDA guidance document on "receipt dates":

1. For the purpose of assigning receipt dates, if an electronic submission covered in this guidance arrives via the ESG Monday through Friday, it is deemed to have arrived at FDA on the date and time corresponding to the Official Center Acknowledgment (second acknowledgment) that is automatically sent to the submitter by the ESG.

2. When an application is submitted electronically, the submission and receipt occur at almost the same time.