Replies to post #127375 on Biotech Values

[DewDiligence]

NVO submits US NDA for Degludec/Degludec-Plus:

http://hugin.info/2013/R/1551031/477640.pdf

The data package is identical to the European submission made three days ago.

[DewDiligence]

FDA extends NDA review of NVO’s Tresiba (a/k/a degludec) long-acting insulin by three months:

http://in.reuters.com/article/2012/06/08/us-novonordisk-degludec-fda-idINBRE85709520120608

The extension also affects the FDA’s concurrent review of Ryzodeg (a/k/a degludecplus), which is a combination of degludec and NVO’s NovoLog mealtime insulin. The new PDUFA date for both products is 10/29/12.