heute 220er bid in australien (ca.1,25€)
denke mal da ist vielleicht noch ein bisschen abwärtspotential möglich
die gestrigen us verkäufe müssen nichts mit psd zu tun haben
wir sehen es ja überall,
notleidende banken und fonds verkaufen auf teufel komm raus.... ;-(
und zur rechten zeit gleich eine news ;-)
(von heute morgen)
pSivida Corp: DSMB Supports continuation of the Phase III clinical trial of Iluvien for the treatment of DME
Brian Leedman
Details anzeigen 07:10 (Vor 2 Stunden)
Global drug delivery company, pSivida Corp. (NASDAQ: PSDV, ASX: PVA, FF: PV3) today announced that after completing its review of safety and efficacy data currently available, an independent Data Safety Monitoring Board (DSMB) has once again recommended that the two pivotal Phase III clinical trials, known collectively as the FAME™ (Fluocinolone Acetonide in Diabetic Macular Edema) Study continue under the current protocol, without change. The trial is studying the use of MedidurTM FA for the treatment of diabetic macular edema (DME) being conducted by our licensing partner, Alimera Sciences. MedidurTM FA will be marketed under the name IluvienTM.
FAME are two, duplicate, double-masked, randomized, multi-center studies following 956 patients in the U.S., Canada, Europe and India for 36 months in support of a planned global registration filing, with safety and efficacy assessed after two years of follow-up.
Enrolment for the FAME study was completed in October 2007.
All patients have now been followed for at least approximately one year and many have been followed for two or more years.
Currently, nearly 8 percent of the US population has diabetes. Over time, almost all diabetics will develop some form of diabetic retinopathy, of which diabetic macular edema is the primary cause of vision loss. Based on published data, pSivida estimates that in the United States as many as 300,000 people are diagnosed with DME each year and an estimated 1,000,000 people suffer from DME. Currently, there are no FDA approved drug treatments for DME.
“pSivida is very pleased that the DSMB has once again supported the continuation of this pivotal trial and remain on track to file an NDA for this product in early 2010,” said pSivida Managing Director, Dr. Paul Ashton.
Kind regards
Brian Leedman
Vice President, Investor Relations
pSivida Corp.
Tel: +61 8 9227 8327 Fx: +61 8 9227 6838 Mb: +61 (0) 412 281 780
brianl@psivida.com www.psivida.com