could someone let me know when the pdufa date is for qcor gel, i thought it was oct 2, but i was wrong
according to miller tabek they had a scheduled pdufa meeting with the fda regarding their acthar gel for ms
No meeting date yet. In May the FDA asked for additional statistical analysis on one of the secondary studies in the filing. The company said they would file the sNDA in October. That's next.
I'm not sure what your question is. They intend to file an sNDA in October.http://phx.corporate-ir.net/phoenix.zhtml?c=89528&p=irol-newsArticle&ID=1333579&highlight=