Enrollment in Phase IIb/III DIAS-2 trial resumed following hold 10/06; Phase III data showed it failed to hit the primary endpoint, and 14 of those on the higher of two doses died, although 10 of the deaths are attributed to something other than the drug 6/07

Began enrollment in the previously discontinued SONOMA-3 trial 8/07

received SPA from FDA for the second of two Phase III trials, NAPA-3, which will include 300 patients 12/05; began SONOMA-3 pivotal Phase III trial to evaluate safety and efficacy in 800 patients 2/06; began Phase III NAPA-3 trial to evaluate avoidance of open vascular surgery and other endpoints against placebo 4/06; failed two Phase III studies 12/06; Phase III data from two failed trials showed that 34.9% of patients receiving alfimeprase met the end-point vs. 37.2% of patients receiving

Phase III data indicate a strong trend toward efficacy for the 30-mg dose 6/07

Proceeds with Phase III 3/03; received clearance to enroll pivotal study 12/03; monitors said trial should continue 7/04, 10/04 and 4/05; monitors recommended Phase III trial in treating hemorrhagic shock following traumatic injury continue, after fourth interim analysis involving 500 patients 11/05; top-line data showed that PolyHeme failed to meet its primary endpoints of superiority and non-inferiority at Day 30 mortality in a Phase III trauma study 12/06; pivotal data showed it missed its

Began first of two Phase III trials, each of which will enroll 650 patients; endpoints related to survival and patient independence 11/05; began second Phase III trial, ASP-II; together, trials will evaluate patient function 90 days post-stroke and other endpoints 3/06; Phase III data showed that dosing Viprinex by infusion over five to seven days kept fibrinogen levels low for too long and compromised safety 5/08; data showed it was unlikely to show benefit; the company halted enrollment in the

Began pivotal Phase III in 2000; began second pivotal Phase III trial 2/02; EMOTE trial missed primary endpoint 3/04; ESSENTIAL I and II trials missed primary endpoints 6/05

Began Phase III DORADO trial to evaluate effectiveness in reducing systolic blood pressure in 352 patients 6/06

Began pivotal Phase III program with ARIES I and II trials 1/04; gained orphan drug status 8/04; pivotal Phase III ARIES-2 trial met the primary endpoint of improved exercise capacity and met secondary endpoints 12/05; FDA granted fast-track status 3/06; pivotal Phase III ARIES-1 trial met primary endpoint of improved exercise capacity vs. placebo 4/06; began open-label Phase III ARIES-3 trial to evaluate effect on exercise capacity 9/06

FDA rejected an abbreviated NDA 11/07; FDA provided guidance regarding the abbreviated NDA, requesting additional data from in vitro and in vivo animal tests 4/08

Began Phase III EARLY ACS trial 6/05

CLEAR platelets trial showed superior platelet inhibition and prevention of heart muscle damage 03/05

Data showed that two different doses produced a significant improvement in blood flow 11/06; met its primary endpoint and demonstrated statistical significance for the intent-to-treat population 6/07; submitted NDA 4/08

A 745-patient study showed the high-dose tirofiban is noninferior to Reopro; a 984-patient study showed it significantly reduced the incidence of residual ST-segment deviation after PCI when used with aspirin, heparin and clopidogrel 4/08

Began enrolling patients in a pivotal Phase III study 11/06; completed an SPA with the FDA for the Phase III study 12/06; completed enrollment of Phase III trial 9/07; failed to meet its primary end-point in a Phase III study of reducing the incidence of cardiovascular death or nonfatal myocardial infarction following CABG surgery 2/08; the primary efficacy outcome occurred in 9.3% of patients treated with MC-1 vs. 9% of those in the placebo group 4/08

Submitted an NDA 6/08; FDA accepted for review the NDA 9/08

FDA accepted an NDA 3/08; FDA reviewers found it to be no more effective than placebo; panel voted unanimously that the drug should be approved as a short-term treatment 5/08; FDA granted accelerated approval 11/08

FDA accepted the NDA for priority review and issued a PDUFA date of April 26, 2008 12/07; FDA issued a not-approvable letter, while the CHMP issued a positive opinion 4/08; European Commission granted marketing authorization 7/08

Began Phase III CAPACITY program, two trials to evaluate lung function in 580 patients 4/06; Phase III data showed both high low doses significantly inhibited worsening of the condition compared to placebo 12/06; completed patient enrollment in CAPACITY, a Phase III trial 5/07; CAPACITY 1 and CAPACITY 2 showed overall positive treatment effect, but only the second one demonstrated statistical significance 2/09