Initiated a pivotal Phase III trial 9/07

Started its third of four Phase III trials 10/07; started the fourth trial 12/07; completed enrollment in NB-301, the second of four Phase III trials 4/08; Phase III data showed a significant reduction in body weight, meeting co-primary endpoints 1/09

FDA issued an approvable letter 10/07; received tentative FDA approval 12/07; FDA approved it in 125-mg, 250-mg and 500-mg strengths 7/08

Phase III data showed it did not meet its primary endpoint with statistical significance 10/07

Submitted an NDA 4/07; FDA has accepted for filing the NDA 6/07; FDA granted marketing approval 5/08

FDA accepted for filing its NDA 1/08; received FDA approval under the 505(b)(2) pathway 12/08

Phase III data showed safinamide resulted in improvement in cognitive domains 6/07; product did not reach statistical significance with primary endpoint 8/07; Phase III data showed it met its primary endpoint by increasing daily on time 2/09

Dosed the first patient in its pivotal Phase III trial 11/07; completed enrollment in its pivotal trial 11/08; pivotal Phase III data showed it met its primary endpoint 3/09

Phase III trial demonstrated statistical significance 5/05; completed enrollment in a second Phase III trial 9/07

Met primary and secondary endpoints in a third Phase III trial 9/07; company filed an NDA 10/08; FDA accepted its NDA 12/08; Phase III data showed it met its primary endpoint 01/09

FDA said 5-mg and 10-mg capsules were approvable and another analysis of data was requested 5/06; FDA said extended-release tablet was not approvable and requested another data analysis 5/06; company plans to resubmit the NDA for the drug during the second quarter 1/07; resubmitted its NDA 6/07; FDA delivered a second approvable letter with requests for additional clinical and preclinical studies 12/07

Initiation of open-lablel study for ongoing North American Phase III trial 2/06; received a second recommendation from the European data safety monitoring board to continue its ongoing Phase III trial 2/07; failed to meet its primary endpoint 8/07; discontinued its European trial and said it plans to commercialize the product as a branded nutraceutical 11/07

Began Phase III trial in 1/05; pivotal Phase III study did not achieve statistical significance on either of its primary end-points 6/08; Phase III data showed that ADAS-cog scores for patients in both the treatment and placebo arms had declined by about 7 points by the end of the 18-month trial 7/08

FDA approved the aNDA 07/08

Began Phase III program 5/04; began Phase III trial in patients undergoing colonoscopies 9/04; trial met sedation endpoint, but trials stopped to adjust dosing 3/05; began pivotal program of two Phase III trials and an open-label safety study; one trial will include 300 colonoscopy patients, another will enroll 250 bronchoscopy patients 3/06; pivotal study met its primary endpoints 3/07; Aquavan met its primary endpoint in a pivotal Phase III trial 5/07; filed an NDA 9/07; Phase III data showed

FDA agreed to allow a previously completed Russian study to count as one of two pivotal studies required to gain approval 1/08; pivotal data showed that behavior symptoms were stabilized over a one-year period 3/08; pivotal data showed improvement in the key aspect of cognitive function over a one-year period compared to placebo 4/08; began dosing in a pivotal Phase III trial 6/08; Phase III data showed it works by improving mitochondrial function 7/08

Phase II/III trial in 416 patients showed trends for improvement in efficacy outcomes but not statistical significance 6/06

Reached an SPA agreement with the FDA on two Phase III trials 1/08; started a Phase III trial 7/08; completed patient enrollment in the efficacy portion of its initial Phase III trial 01/09

Phase III trial met its primary endpoint 2/08; submitted an NDA under the 505(b)(2) pathway 9/08; FDA accepted for review the NDA 11/08