Phase-III German biotechnology company LipoNova AG says it has reached important milestones in the development of its vaccine candidate Reniale. After a successful consultation with the US Food and Drugs Administration, LipoNova says it may be granted approval to market its product in the USA on completing a positive Phase III trial, without needing to undertake further studies. In addition, the firm may be able to renew its production license for Reniale in the near future.
For the third quarter of 2007, the company's turnover stood at 10,000 euros ($14,720), compared with 4,000 euros in the like 2006 period. The net loss of 3.1 million euros was affected significantly by regulatory expenses and met the company's expectations. At 90%, the company's equity ratio as of September 30 almost equaled that of December 2006. During the next quarters, LipoNova will continue to implement the measures it has already initiated. These include introducing Reniale into non-European foreign markets, the named-patient programs, securing the company's financial situation and most importantly, launching the Phase-III study.
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