We are particularly proud of Bill and the clinical team along with Dr. White, Dr, Stacy, Dr. Factor and Dr. Kaufmann. They did a great job on the specific safety concerns raised by the Agency. The panelists were clearly interested in understanding the potential risks of wide use.
We also appreciate the input of doctors Temple, Unger and Stockbridge whose input was key on a number of issues. We certainly look forward to working with the Agency as we move forward. All in all, we felt it was a very good discussion.
The committee’s recommendation will be considered by the FDA in its assessment of NORTHERA NDA. A PDUFA action date for NORTHERA NDA has been scheduled for March 28, 2012.
I’d like to acknowledge and thank the patients, especially the particular ones who came today, and the investigators for their participation in NORTHERA trial and for their unwavering support for NORTHERA and Chelsea Therapeutics over the years. Chelsea is excited by the opportunity to play a role in changing the everyday life of these patients. We look forward to continue interaction with the FDA over the coming weeks as it completes its review of NORTHERA.We will now open up the line for questions. Operator? Questions-and-Answers Session Operator: Thank you. (Operator Instruction) Our first question comes from Robyn Karnauskas from Deutsche Bank. Robyn Karnauskas – Deutsche Bank Securities, Inc. Thanks for taking my question. I know it’s been a very long day for you. I guess the first thing that comes to mind is that the panel sort of unanimously suggested that you should do another trial to support approval and comments on maybe looking at longer duration of therapy, and given that if you were to still use that endpoint, 306 trial really didn’t work if you used the OHQ endpoint in the specific way you looked at it and the specific patient population. So what do you think – when you go to the FDA, what kind of trial might you suggest to support approval? Is it the fall trial that you are doing or are there other options on the table? Read the rest of this transcript for free on seekingalpha.com
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