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Novo Nordisk reported to the police by the Danish Financial Supervisory Authority for violating disclosure obligation

Posted: 10 December 2013 | | No comments yet

The reporting relates to the company’s receipt of a Complete Response Letter from the US Food and Drug Administration…

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The Danish Financial Supervisory Authority today reported Novo Nordisk A/S to the police for violating its obligation under Section 27 (1) of the Danish Securities Trading Act to disclose inside information as soon as possible. The reporting relates to the company’s receipt of a Complete Response Letter from the US Food and Drug Administration (FDA) in the evening of Friday 8 February 2013. In the letter, the FDA stated that approvals for the insulin products Tresiba® and Ryzodeg® could not be granted on the basis given.

Novo Nordisk published the FDA’s decision in a company announcement on Sunday 10 February following an intensive investigation and evaluation of the implications and impact of the agency’s decision. The Danish Financial Supervisory Authority is of the opinion that Novo Nordisk should have issued a company announcement already on Friday evening.

Novo Nordisk is of the opinion that the company announcement was issued in a timely manner, but acknowledges the decision of the Danish Financial Supervisory Authority and will cooperate with the relevant authorities in their investigation.

Novo Nordisk’s view is 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 analysed, which they had been on the Sunday.

On 12 February 2013, NASDAQ OMX Copenhagen launched a similar investigation into whether Novo Nordisk had violated the disclosure obligations applicable to all companies listed on the stock exchange. On 8 May, NASDAQ OMX Copenhagen informed Novo Nordisk that the stock exchange found no basis for concluding that Novo Nordisk had violated the rules, and that it considered the matter closed.