Began Phase III trial 8/05

Began TIGER-1 trial to evaluate drug vs. placebo in 350 patients with mild CF lung disease 7/06; completed enrollment in the first of two planned pivotal Phase III trials 10/07; launched the second of two pivotal studies 2/08; Phase III data demonstrated statistical significance for its primary efficacy endpoint 6/08; company modified the protocol for TIGER-2 to increase the length from 24 weeks to 48 weeks 7/08; data showed that patients who continued to receive denufosol for an additional 24

FDA sent approvable letter asking for new trial 12/03; began Phase III trial 6/04; missed primary endpoint 2/05; submitted amendment to NDA with data from two more Phase III trials 6/05; FDA issued second approvable letter, saying trials failed to demonstrate efficacy 12/05; company said it met with FDA regarding the approvable letter 3/06; reached agreement with the FDA for an SPA of a Phase III trial 1/09

Started pivotal Phase III trials 12/07

Health Canada approved it 6/08

Began Phase III trial under FDA SPA to compare product to Visicol 9/04; trial showed non-inferiority 2/05; filed NDA with FDA 5/05; FDA accepted NDA for review 7/05

Began a Phase III trial 09/08

Follow-up data showed it continued hormone suppression with no break-through of hormones and led to continued decreases in rates of growth, skeletal maturation and BMI at 24 months compared to 12 months 5/08

FDA accepted for review the firm's NDA 11/07; filed new data with the FDA regarding the existing NDA; it showed lower, more frequent doses were well tolerated and met their efficacy endpoints 1/08; Phase III data showed that 94% of men had their testosterone levels restored and maintained to within normal levels and 92% expressed satisfaction with treatment 5/08; FDA asked for more safety data, potentially delaying approval for two years; company received official approvable letter 6/08

FDA panel voted 7-2 that DOR has not demonstrated a substantial benefit with orBec 5/07

Phase III trial in Europe demonstrated statistical significance at the highest dose levels 8/06

Received a positive opinion from the CHMP recommending approval 10/07

Responded to the FDA's questions regarding the NDA 1/08

FDA approval likely will be delayed because stability studies detected small amounts of precipitated material in scale-up batches of Zensana 2/07; withdrew NDA due to a manufacturing issue 3/07

Data from a volunteer study showed it could be delivered rapidly subcutaneously in well-tolerated manner without need for infusion pump 1/08

Completed enrollment in a pivotal study 2/08

Phase III data suggested a significantly improved gastrointestinal tolerability as well as safety profile compared to oxycodone HCl IR 6/08

Phase III data showed a 28-day treatment course improved respiratory symptoms 10/07; Phase III data of CF patients with pulmonary Pseudomonas aeruginosa showed it has met its safety goals in its continuing study 6/08

Began second of two Phase III trials, which will evaluate safety and tolerability in children younger than 7 years 5/06; Phase III data showed two trials met all primary and secondary endpoints 4/07; initiated the rolling submission of its NDA 6/07; NDA was accepted for review and given priority review status 2/08; received an approvable letter that does not require any additional clinical studies 6/08