My Tracleer new business has dropped so much I am afraid I will be put on a plan soon....other than ILD, do you guys have any advice how to handle this? I have done a bunch of speaker programs but not ONE speaker I have brought in will really nail ambresentan. Any ideas? My ventavis numbers are OK.
This should help. We're starting to look like Encysive, maybe Pfizer will by us and give us a nice reverence package. US Food and Drug Administration issues complete response letter regarding the Tracleer® supplemental New Drug Application - Completion and Approval of Risk Evaluation and Mitigation System (REMS) submission required for final FDA review for inclusion of less severe PAH patients in the product label ALLSCHWIL/BASEL, SWITZERLAND - 02 March 2009 - Actelion Ltd (SIX: ATLN) announced today it has received a complete response letter from the US Food and Drug Administration (FDA) regarding the supplemental New Drug Application (NDA) the company filed in August 2007. In this supplemental NDA, Actelion asked that the US product indication be expanded to include patients suffering from Pulmonary Arterial Hypertension (WHO Group I) with less severe disease (WHO Class II - IV symptoms). Since November 2001, Tracleer® has been commercially available in the United States for PAH patients with WHO III-IV symptoms. In its Complete Response letter, the FDA has informed Actelion that the REMS submission (Risk Evaluation and Mitigation Strategy) Actelion submitted in September 2008 needs to be finalized and approved before the FDA will then, in turn, be able to conclude the review of the supplemental Tracleer® NDA expanding the indication to the less severe PAH patient population. Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion, commented: "We will continue to diligently work with the US Food and Drug Administration on the ongoing REMS submission in order to expand the US product label to include less severe PAH patients."
FC 2 will never happen. The data just is NOT there no matter how many ways HO slices and dices it. It just not there.
Yeah, that's what the peer reviewers at LANCET said too, but then they went and published it anyway. Now why would they go and do a thing like that? Maybe because you don't know dickshit about PAH?
Knowing FDA, they will approve the FC II indication the same day the first generic of Bosentan hits the market.
Now thats funny. To the OP, sorry to hear of your troubles. If you think its bad now, wait til the Cialis launch.
