page 333 : piège tendu à NicOx sur outcome study ?

DR. DIXON: May I ask for a point of clarification? Is it too late? With reference to the need for longer-term outcome studies, is it the conclusion that such studies are needed for all members of the class of NSAIDs or are we singling out this particular product for demanding those kind of studies?
DR. O'NEIL: I don't believe the discussion addressed that and I was just trying to summarize. So I'm going to buck that answer.
But unfortunately for the sponsor, they started - they planned these studies, they started these studies before the rofecoxib debacle, and we are in a new world with more data every day.
Dr. Hertz, you have a comment for that?
DR. HERTZ: So we've already mentioned that for something that was truly novel, that they would need to come in with outcome studies to look at the cardiovascular effects.
But with regard to what I've heard, agree with Dr. O'Neil's summary in terms of what's needed for this product. Does that sort of answer your question?
I would just like to take this opportunity to thank the committee. As you can see, we don't take the easy ones to committee. If we had all the criteria and all the study designs established, we would not need to call on you to help us with these difficult decisions.
So we greatly appreciate your deliberations, the questions, the challenges that you've posed, and your taking the time from your very busy schedules to come and give us this assistance.
I'd like to also thank Dr. O'Neil for chairing. We really appreciate that, your ability to keep the meeting on track and to provide clarity with each discussion point. So thank you all.
DR. O'NEIL: This meeting is now adjourned.
[Whereupon, at 3 p.m., the meeting was adjourned.]

Hi Simis !

De toute façon, ils auront toujours raison...
Il trouveront le petit point à éclaircir ; "petit point" qui nécessitera de longues études...

Mais le Napro est "prometteur"...

Wait & see

HI D@N !

mouais ça sentait le traquenard ...

Le pire, c'est que la réunion s'est terminée là dessus. Ils ont du se sentir mal le staff Nicox sur le coup...

agréable pour personne même professionnel d'être renvoyer dans

les starting block après un faux départ, espérons qu'il s'agissait que

d'un carton jaune

La FDA n'avait qu'à prévenir Nicox après le retrait du Vioxx, ils ne l'ont pas fait, il y a une raison.

Ce n'est pas au panel de décider des études supplémentaires à réaliser à moins que ce ne soit le même panel que pour le Vioxx et qu'ils aient une peur bleue de refaire la même erreur. Dans ce cas il faut qu'ils changent de job ou qu'ils refusent de faire parti d'un panel (ce qui doit rapporter pas mal d'ailleurs...).

"a new world", non mais c'est pas la décision du siècle non plus!

Pas de demande FDA, pas d'études sup, c'est tout.