Regarding Belviq's path through the EMA approval process, Arena CEO Jack Lief said the following at the J.P. Morgan Healthcare Conference:
We've responded to the 120-day questions, which were very similar to what the FDA asked us, questions that we responded at FDA. We're waiting for the 180-day assessment, which we expect this quarter. And as I said, we expect a final decision in the first half of this year.
Those aren't the words of a CEO expecting good news from Europe in February. In fact, Arena may find itself appealing a European rejection of Belviq, just like Vivus is doing with Qsymia.
-- Reported by Adam Feuerstein in Boston.Follow @AdamFeuerstein
Check Out Our Best Services for Investors
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Model portfolio
- Stocks trading below $10
- Intraday trade alerts