Posted by Marty on September 24, 2008, at 17:16:04
In reply to Re: Agomelatine Approval .. Who's with me ?, posted by Nadezda on September 24, 2008, at 16:59:02
Hi Nadezda,
I agree with everything you said.
> Do you think a petition would really make any difference with the FDA or EMEA?
---
Depending on the amount of signature and the credibility of the 1 or 2 Psychiatrist supporting the open letter, yes. Very unlikely that it would make them approve a drug that they wouldn't have approved anyway, but the whole idea is to speed up things.. to let them know that people are watching them, scrutinizing them and expecting from them. If published in a medical journal, it would also stimulate (slightly) discussions between some people in the field and increase interest in this drug. Historically, Americans aren't very fond of Servier psychopharmalogical drugs and telling them (the FDA) we care about those would make them less comfortable in blocking the approval of those drugs in America: Amineptine BLOCKED. (Not only blocked here, but the FDA also pressurized Servier to withdraw it from other countries!), Tianeptine (Hard entry, so somehow passively blocked)... and now they are ****ing about Agomelatine ? There's no reason./\/\arty
poster:Marty
thread:853681
URL: http://www.dr-bob.org/babble/20080915/msgs/853836.html