COPENHAGEN--Danish financial regulators took a dim view of Novo Nordisk's decision to spend the weekend pondering the FDA's February 2013 snub to Tresiba before spreading the news of the agency's complete response letter and the major delay that would be triggered by its demand for a new study. And today Novo ($NVO) said it had decided to accept a $90,000 fine to close the books on the incident, not the least bit chastened at the slap on the hand.
The FDA's demand caught the company off guard, CEO Lars Rebien Sørensen told FierceBiotech in an interview last week. Regulators had specifically not required the kind of cardiovascular study the FDA demanded for Tresiba, as they had clearly avoided such trials in the past for an insulin product. The FDA had also issued a CRL for Ryzodeg.
The pharma giant has made a major recovery over the past year, but at the time the setback wiped out some $14 billion of market value as investors reacted with a horrified stampede.
In its release today, Novo noted that it received the CRLs on Friday evening and put out its release on Sunday after it had taken some time to review the situation. And it retrospect, the company still doesn't think there was anything wrong in their actions.
"Novo Nordisk is of the opinion that the company announcement was issued in a timely manner," the company said in a release. "The company maintains that even if the disclosure obligation could be said to apply already on the Friday evening, the company was entitled to delay public disclosure until the implications of the decision had been adequately analyzed, which they had been on the Sunday. However, for resource reasons Novo Nordisk's management has chosen to accept the fine to avoid a lengthy lawsuit. This will finally settle the case."
- here's the release