Replies to post #114630 on Amarantus Bioscience Holdings Inc (AMBS)

[JJAAMMAANN]

$AMBS$ ODD process by FDA
What is the review process like once application is received in OOPD? How is a designation application reviewed in OOPD? Please describe the review process for a designation application.

Following receipt of the Orphan designation application, the OOPD review process is as follows: The application is assigned a designation application number and logged into OOPD database and an acknowledgement letter is sent to the sponsor. The assigned OOPD reviewer completes the review of theapplication by preparing a review. The review is forwarded to the OOPD Team Leader for a second level review and concurrence. The review is forwarded for a 3rd level review by the OOPD Office Director. Following the OOPD Director’s concurrence, a designation letter, a letter requesting additional information, or a denial letter is prepared for the Director’s signature and the letter is issued to the sponsor.

I'm guessing we are just not quite there yet...it is a process...not a rule.