Novo compounds Tresiba troubles
Novo Nordisk says it needed time to digest the FDA's February Tresiba rejection before making the news public, but Danish authorities disagree and are investigating the drugmaker over its decision to wait two days to make the FDA's decision public, reports Reuters.
The timeline as well as the news are critical aspects to the story, as Reuters notes that although the FDA delivered its decision after Danish financial markets closed, US markets were not, and trades were still possible. The Big Think included an hour-long conference call, reports Reuters, which says the company published the information at night on Sunday, February 10.
The FDA rejection was an investor upset, and the regulator said it needed cardiovascular safety information before it would consider the drug for approval. This fail gave Sanofi's Lantus franchise one less competitor, and delayed Novo's Tresiba entry by a few years.
Sydbank analyst Soren Lontoft Hansen told Reuters that this is more of a reputation problem for Novo, instead of a financial one, but that the financial aspect could become more significant were US shareholders to pursue a joint action lawsuit.