Novo Nordisk Probed By Danish Police Over Tresiba Disclosure

Last February 10, Novo Nordisk issued a statement saying the FDA had rejected its Tresiba insulin and wanted a cardiovascular outcomes trial before a new review can be completed, a move that was a difficult setback for the drugmaker because such a trial would likely delay regulatory approval of an important new product for at least two years (back story). That Sunday disclosure, however, did not sit well with the Danish Financial Supervisory Authority, which has reported Novo Nordisk to the police for violating reporting obligations under the Danish Securities Trading Act to disclose inside information as soon as possible, which would have been on Friday evening, February 8. A Novo spokesman tells Reuters that its US unit received notification from the FDA around 5 pm Danish time that Friday, just as the Copenhagen market was closing, but it only sent the message on to headquarters "some hours" later. The drugmaker apparently did not waste time, though, reporting this latest development – a statement was issued today on its web site. The decision by the FDA to issue a complete response letter for Tresiba, as well as a related combination drug called Ryzodeg, surprised investors, who believed Novo would not encounter any obstacles winning approval. Only two weeks earlier, Novo ceo Lars Soerensen told analysts that progress was being made in talks with the FDA and there was no indication that approval might be delayed (see this). His comments were made following a recommendat...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs