Posted On: 05/20/2016 3:07:26 PM
Post# of 72447
THIS is why CTIX schedules meetings with the FDA and revises trial protocol to meet whatever protocol the FDA wants.
http://www.fiercebiotech.com/a-showdown-sanof...RHM9In0%3D
Quote:
Novo Nordisk’s regulatory team will need to spend some time next Tuesday explaining to an FDA advisory panel just how it designed a big late-stage program for its combination of Tresiba (insulin degludec) and Victoza (liraglutide), a once-daily injectable dubbed IDegLira.
That combination of a GLP-1 drug and basal insulin proved superior to either of the two treatments provided to patients alone, according to Novo. But an internal assessment at the agency concluded that the trial design was biased in favor of the combo, making it impossible for the FDA to agree on that point regarding its superiority to Tresiba.
http://www.fiercebiotech.com/a-showdown-sanof...RHM9In0%3D
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