There were no other statistically significant findings on any of the other pre-specified secondary endpoint in both trials and pirfenidone treatment was not associated with a worse outcome on all endpoints.. In CAPACITY 2, pirfenidone treatment was associated with a statistically significant effect on the pre-specified secondary endpoints of the PFS and categorical change in FVC compared to placebo. A PFS event was defined in the study protocol as the time to death, a 10 percent decrease in FVC or a 15 percent decrease in DL defined. In CAPACITY 1, pirfenidone treatment, with a statistically significant effect in the pre-specified secondary endpoint of six-minute walk test distance was associated versus placebo.
Pirfenidone achieve statistical significance on the primary endpoint in one the two pivotal clinical trials and there can be no assurance that the regulatory authorities in either the United States or Europe granted granted approval to the efficacy data from a single pivotal trial basis, in combination with the other efficacy and safety results the company currently intends to submit in support its NDA and MAA filings. Further analyzes of the capacity results will be done in the future and possibly some complementary observations, the existing to material change in the Company’s regulatory strategy for pirfenidone, including a decision by the company not with one or two of the lead regulatory filings in the United States and Europe.Within two years of is Terrafirma of Nigel by Nigel Press Associates under ESA GMES Service element of feature satellite processed satellite radar coverage to reveal small ground movement for One city in any country EU.
Over the last five years, new ways of processing satellite signals radar stock photos using using Persistent Scatterer Interferometry , which detects ground movements over large areas and to control with still greater hypersensitivity be able.. Problem problems, Terrafirma be to recognize provide a Pan-European ground motion HazardClass Information Services monitor and raise ground movement in terms of building stability, and ground subsidence, landslides, earthquakes and engineered excavations. Since over 15 years was Synthetic Aperture Radar Interferometry has been the provision with centimeter precision ground deformation information.