Question-and-Answer Session
Operator
(Operator instructions) Your first question comes from Derek Jellinek.
Andrew Thorning
Hi guys, this is actually Andrew Thorning [ph] for Derek. Just a quick question on PROMACTA, looking at the filing strategy for GSK and sort of the long-term use, I know there was a lot of talk coming out of the FDA panel meeting and sort of panel members about short and long-term use, there wasn’t really a difference because of the concern of the rebound effect. I was wondering if you could comment on can we read anything into the GSK filing strategy, their chronic use and has it been affected by the back and forth between GSK and Agency over their current NDA.
John Higgins
Thank you, Andrew. I will open by saying that we really don’t have any insight directly in terms of the dialogue between GSK and the FDA as you suggest there is back and forth. So, actually we can’t comment on that directly. As far as the filing strategy, just its background, GSK filed December of last year off of one pivotal trial the initial end point was a six-week period of evaluation and it is our understanding that they had agreement from the FDA that they could file with one pivotal trial. All along there was a second pivotal trial that was a six-month study and that study while it was not included in the original NDA the expectations of that would be submitted once that study was finished up. So, it wasn’t so much a change in regulatory strategy all along GSK expected as they did to file which just one study and we anticipate that there will be data available from the second study over the next several months. We don’t know exactly when or how that will be made available but it is our estimate that that study is finished at this time.
Andrew Thorning
Okay and I guess that the question had to do with after the meeting in June, I think there was some thinking that the Agency may be a little bit more lenient based on the discussions at the panel meeting with the labels something similar to end play even though the short-term data was all that the Agency had available. I guess could you comment on the possibility for that if you think that that could be possible or if a label would likely be for the short-term use only and then amended sometime next year.
- To read the full transcript on Seeking Alpha, click here »
