SLC post about NCE status.
slcimmuno Member Level Saturday, 05/13/17 11:49:02 AM
Re: Blues44 post# 181850
Post # of 181919
Thx more 505b2 info the better
Re Prurisol, I think this is the right way to go - leverage Ziagen data (long-term safety profile). It also looks like CTIX will be going for NCE status, though much less common for 505b2 drugs, it has happened (can't find cite, was in a blog post on Camargo, 505b2 consulates, website). Even if P isn't granted NCE and the 5 year exclusivity that goes along with it, they can likely get the 3yr exclusivity tied to the "new clinical investigation" provisions -- and they do have a patent that runs to 2032. So IP is looking robust.
slcimmuno Member Level Saturday, 05/13/17 11:49:02 AM
Re: Blues44 post# 181850
Post # of 181919
Thx more 505b2 info the better
Re Prurisol, I think this is the right way to go - leverage Ziagen data (long-term safety profile). It also looks like CTIX will be going for NCE status, though much less common for 505b2 drugs, it has happened (can't find cite, was in a blog post on Camargo, 505b2 consulates, website). Even if P isn't granted NCE and the 5 year exclusivity that goes along with it, they can likely get the 3yr exclusivity tied to the "new clinical investigation" provisions -- and they do have a patent that runs to 2032. So IP is looking robust.