Replies to post #25405 on Grapefruit USA Inc (GPFT)

[IMGGorBust]

I'm trying to help you understand the FDA organization, but if you don't want to listen that's up to you. Heather is in a key policy role and is very much involved in developing the 510(k) program at the program level. She has been very much involved in the proposed changes to the program itself, but she is not involved at the ground level for the device by device application decisions. Go back and listen to Dean's conference calls and you will hear him identify who has participated in his interactions at the FDA. It's the Reviewer and Jeff. That is consistent with how these applications are routinely handled at the FDA.