I aksed Ai Chat if this was unusual and recieved this as an...

I aksed Ai Chat if this was unusual and recieved this as an answer. Note; Ai is not always 100% accurate.

Yes, it is common for sponsors to submit an Orphan Drug Designation (ODD) application to the U.S. Food and Drug Administration (FDA) before obtaining full clinical trial results.

The FDA acknowledges that limited clinical data may be available at the time of submission, and it expects additional information to be provided later. Therefore, it is not uncommon for sponsors to submit an ODD application early while planning to gather more data during subsequent stages of clinical development.It is important to note that the FDA may require more supporting data or evidence as the drug progresses through clinical trials and the subsequent drug approval process.



Keep in mind PAA will be using a company that specializes in ODD applications to steer them through the process, this all those companies do and understand the process. I think Quiltman provided info on this some time back.