Question-and-Answer Session
Operator
(Operator Instructions) First question will go to Biren Amin with Stanford.
Biren Amin - Stanford Group
Hi Martine, hope you feel better today, I was just wondering if you could maybe discuss deign of this new FREEDOM study. We see similar primary end points with the six minute walk and the new FREEDOM file?
Martine Rothblatt
Sure, Roger can you answer that question?
Roger Jeffs
Yeah, certainly Martine, and thank you for the question. I will preface my comments with echoing what Martine said in just reminding the caller that, note that oral is now an early Phase III program and with the scenarios that I will describe at best on blinding will be in about two years and material revenues will not contribute for full years and more. Having said that what our intention is with the ongoing FREEDOM-M or the monotherapy study which currently has 171 patients enrolled is will add about 140 patients. So that will take sample size to around 310 patients.
All of the 140 patients that we will add will be added with in to the 0.25 milligram starting dose. So all of those patients will have access to 0.25 for both dose start and dose increment.
In total given the patents had access to the 0.25 of the 171 that are already enrolled that will give us around 200 patients that had exposure from the beginning of the study to 0.25 milligram tablet and throughout the study that will give us a 90% power to detect of 45 meter difference at the P less than 0.01 level and certainly if successful we would have a single study that potentially would be a regulatory interest for filing.
So that’s our intention the amendment will be sent to the FDA shortly, and then we will begin the study probably in the April timeframe once the FDA approves the amendment and IRB and ethic committees around the world also approve the amendment. We were the reason, I gave the two year scenario for data is we were doing about 8 to 10 patients per month at the end of the FREEDOM-M study when, of the 171 patients enroll. So that would predict around 14 months enrollment three months with to conduct the study and then a couple of months to do the data analysis cleaning and unbinding, so that's were the two year window comes from around FREEDOM-M.
- To read the full transcript on Seeking Alpha, click here »
