Now turning to Arbaclofen Placarbil or AP, we expect completion of enrollment of the pivotal Phase 3 trial for the treatment of spasticity in MS patients this fall and topline results in Q1 of 2013. Patients who complete this trial are eligible to continue AP treatment in the six-month open-label safety study.As I mentioned in our last call, we initiated communication with the FDA to discuss the possible need to modify our trials to ensure that we meet the FDA's safety data requirements of 150 subjects with six months and 100 subjects with nine months of AP exposure.
Xenoport's CEO Discusses Q2 2012 Results - Earnings Call Transcript
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