Replies to post #184600 on Biotech Values

[DewDiligence]

FDA accepts Apotex’s 351(k) submission for Neulasta FoB:

http://finance.yahoo.com/news/apotex-announces-fda-accepted-filing-152300574.html

[DewDiligence]

NVS’ Neupogen FoB gets clean bill of health from FDA staffers for Wednesday’s advisory panel:

http://in.reuters.com/article/2015/01/05/us-novartis-amgen-fda-idINKBN0KE12120150105

The reviewers recommended that Novartis's copy should be approved for all the five indications for which Neupogen is approved, the FDA said on Monday. Independent experts are scheduled to meet on Wednesday to discuss the drug and recommend whether it should be approved.

This is the first 351(k) (biosimilar pathway) application to reach the advisory-panel stage.