The two doses in the label are 15 milligrams and 20 milligrams twice a day, which were quite well for people who have platelet counts above 100,000 and we are challenging for people with platelet counts below 100,000. Because one of the major reversible side effects of using the drug are myelosuppression both decrease in platelet count and decrease in red count, although that latter is a somewhat transient phenomenon because there are recovery mechanisms that occur while you are still on the drug. So the platelet count early on can go down, it goes down below a certain level patients have to discontinue the drug.
And we have – since launched on a very nice study in low platelet count patients where we start them on a lower dose 5 milligrams twice a day and work up and we are finding that almost all of them can get to 10 milligrams BID and at that does they are getting essentially the same results on spleen reduction symptom relief that the less sick patients get at the higher doses and we put that in – we send that to the FDA for an update on the label and when requested we are obviously explaining that to physicians who might start a patient with low platelet count on the drug.
But as you might expect those patients were sick, much significantly sicker than the patients that we are currently seeing coming to the group of people who are now getting the drug and who we studied in Phase III. So some of them died, some of them can't tolerate the higher doses, so early on the discontinuation rate was higher. It seems to be modulating.
Select the service that is right for you!COMPARE ALL SERVICES
- $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
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass + 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV