Dr. Traber continued, "The NASH-FX study will be a shorter, four-month trial in 30 NASH patients with advanced fibrosis, but not cirrhosis, randomized 1:1 to either 8 mg/kg of GR-MD-02 or placebo." This study is entitled "Phase 2 Study to Evaluate Non-Invasive Imaging Methods in Efficacy Assessment of GR-MD-02 for the Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis," and details can be found here.
"The non-invasive assessments included in this trial include LiverMultiScan (a multi-parametric nuclear magnetic resonance imaging method developed by Perspectum Diagnostics(TM)) as the primary endpoint compared with magnetic resonance elastography and FibroScan as secondary endpoints. This study is expected to begin enrolling patients in July 2015, and will be performed at Brooke Army Medical Center in Fort Sam Houston in Texas, with top-line data readout in the second half of 2016."
It works on pulmonary fibrosis. It may work in renal...LJPC wasn't up to taking on the FDA for years and years.
The portfolio reprioritization is the result of both the addition of the next-generation gentamicin derivative program and a recent interaction with the U.S. Food and Drug Administration (FDA) regarding La Jolla’s galectin-3 inhibitor program. In this interaction, the FDA indicated that the Company would be required to conduct additional chemical characterization of GCS-100 prior to further clinical development. GCS-100 and LJPC-1010 are complex polysaccharide mixtures that cannot be readily chemically characterized using conventional analytical methods, and the Company believes that the timeframe and ultimate success of developing analytical methods that would satisfy the FDA’s requirements are highly uncertain. There were no issues raised by the FDA related to patient safety or preclinical toxicology.
Science remains compelling. Some missteps by management, for sure.
Willing to sit and wait. No worries.
I eat my spree..
participants on GALT. Not going to cut and paste, just go over there and look.
I also find the science compelling and willing to sit and wait. Forget the idiots here. They are just that, idiots.
at least you are not down that much based on your cost average. I'm taking a lickin here, but still tickin
With IDIX I had a good feeling about their science and I even called the MRK buyout.
I think the science here is yet to be proven, however, this is far from over, despite what the stupid individuals say on this MB who have no scientific background.
I bet we will have the same conversation 6 months from now. They may need a secondary and/or a partner..BUT, one good result from their trials and we fly.
Problem here is the utter secrecy from management. I tend to view that as a positive sign....
you're a loser, and a sore, miserable loser.