Al di là delle vicessitudini di questo medico....meglio leggere meglio questo passaggio....
Mi piacerebbe avere un parere anche da Coxi, se gli va !!
What can we learn? Could things have been done differently? If NicOx had asked me a year ago, here is what I would have told them:
1. Naproxcinod would be approved if they went in purely as an NSAID since the data do support such a claim.
2. The endoscopic studies were too short, used the wrong kinds of subjects, and the wrong endpoints. There are enough studies showing the way (which is why I showed the Celecoxib data), and clear FDA guidelines, so I’m surprised that the company proceeded the way they did.
3. The cardiovascular effect was not sustained label was not likely. Once again, there are FDA guidelines, and precedence of other compounds. Especially with the data showing lack of sustained lowering of blood pressure.
I think the science is interesting, and the compound has potential. If developed properly.