One of two Phase III trials completed 5/00; primary endpoint was statistically significant in second Phase III trial 9/00; enrollment completed in efficacy study 12/03; submitted marketing approval application to EMEA 1/04; European regulators asked for more data on marketing application 3/05; completed its submission of the final portion of the BLA 8/08

Pivotal Phase III data showed it improved exercise capacity and delayed clinical worsening 5/08

Began a second Phase III study 8/08; began two Phase III studies and a Phase II trial 1/09

Began Phase III trial to evaluate survival in 80 patients with VOD with multiple organ failure as a complication of stem cell transplantation 3/06; trial showed 58 patients receiving it twice daily for 28 days demonstrated efficacy 6/07; data safety monitoring board initiated the planned interim analysis of the Phase III study and concluded there were not safety concerns 1/08; independent data safety monitoring board recommended that Gentium confirm the criteria used to select historical control

Began pivotal Phase III trial to evaluate efficacy with best supportive care against that care alone in up to 273 patients 9/06

Filed a formal appeal with the FDA seeking approval of Vasovist, following three denials by the agency 2/07; FDA has determined that additional trials may not be needed for approval 6/07; Phase III data showed that Vasovist met all of its pre-specified endpoints 4/08; resubmitted the NDA 7/08; FDA approved Vasovist 12/08

Phase III trial failed to demonstrate statistically significant improvement in primary endpoint but did show benefit in secondary endpoint related to depression 9/06; drug demonstrated a trend in reducing the level of anxiety vs. placebo in Phase III 6/07

STRIDE-2 trial met primary endpoint 2/05; filed NDA with FDA 5/05; FDA accepted NDA for filing 7/05; extension study from Phase III STRIDE 2 showed advantages in some end-points 9/05; FDA issued an approvable letter outlining need for additional clinical work 3/06; in second approvable letter FDA said one issue remains unresolved 7/06; company was notified that the product is being approved in Europe 8/06; submitted complete response to the FDA aprovable letter 11/06; FDA accepted for review the

FDA requested a small, confirmatory trial before approval could be recommended 8/06; findings demonstrated clinical response for all dose levels; completed double-blind portion of pivotal Phase III trial, EDEMA3 11/06; Phase III data showed it hit the primary and secondary endpoints; began patient treatment in a Phase III confirmatory study 4/07; completed the patient treatment phase of its second Phase III trial 6/08; met its goal of reducing symptoms in a second Phase III trial 8/08; filed a

Began pivotal Phase III trial under FDA SPA in 3,400 at-risk patients who have a variant to a certain gene identified by DeCode 5/06; voluntarily suspended Phase III trial due to unexpected formulation problem 10/06

Began second Phase III trial 4/04; pivotal Phase III met primary endpoint 8/05; the second of two Phase III trials met its primary endpoint 12/06; filed an NDA 5/07

Submitted a BLA 3/08

Began patient enrollment in a Phase III trial 10/07

Began Phase III VISION to evaluate safety and efficacy in combination with sildenafil in 180 patients 3/06

Enrolled the first patient in its pivotal Phase III study 1/08

Reached an agreement with the FDA on an SPA for the design of Study 301, a pivotal Phase III trial 2/08; started patient dosing in two pivotal Phase III studies 9/08; data demonstrated a robust reduction in the severity of symptoms and an improvement in standing systolic blood pressure 02/09

Started recruiting female patients for a Phase III trial 5/07; Phases IIb/III data showed significant improvements in multiple clinical measures 8/07

Began open-label ACT 4 trial to evaluate the safety of intravenous RSD1235 10/05; submitted an NDA seeking approval to market the I.V. formulation 3/06; FDA refused to file NDA 5/06; FDA accepted for review the NDA 2/07; Phase III data showed that 47% of dosed patients got conversion to normal heart rhythm within 90 minutes, compared to 14% of placebo patients 6/07; federal advisers told the FDA that it should approve Kynapid 12/07; pivotal data demonstrated that 75 of the 145 Kynapid patients

Began Phase III; positive results published 2/00; enrollment completed in U.S., Europe, Canada and South Africa 7/00; approved in South Africa 4/01; positive results 5/01, 8/01 and 3/02; filed BLA for acute anemia 7/02; FDA accepted BLA 10/02; FDA asked for additional info 8/03; FDA had questions on BLA 10/03; FDA put proposed RESUS trial on hold until certain issues are addressed 7/05; filed MAA in the UK for treatment of acutely anemic adult orthopedic surgery patients younger than 80 7/06