At this point, I would like to turn the call over to Dr. Plachetka.
John R. Plachetka
Thanks Stephanie, good morning and thanks for listening in today. Let me start by talking about this brief statement and we’ll open the call up for questions. I hope you had a chance to read our press release on the outcome of the Type A meeting we had with the FDA this week. And although you can probably tell from the press release that this is a positive outcome, we wanted to provide you an opportunity to get some of your more specific questions answered.
But first, let me just reiterate how pleased I am that we now feel we have a path forward to include both doses in the NDA, giving clinicians and patients a choice of a low and a high-dose version of PA. We’ve been asked many times over the years of this development program, why did we just make the 32540 when it seems that most patients take a lower dose, in fact they do. Well, now we have the best answer, and that is that we’re developing both strengths.Our clinical and market research data suggests that two-thirds of the aspirin used for cardioprotection is at the lower dose, and about one-third is at the 325 milligram dose. So being able to include both doses in the NDA, not only will be able to offer patients a choice if both products are approved, but PA could be used by all aspirin patients who might be at risk for gastric ulcers instead of just the one-third of the patients who use 325. So that’s a nice impact on the market opportunity.Read the rest of this transcript for free on seekingalpha.com
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
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
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV