Anavex Life Sciences Corp (AVXL)

[nidan7500]

from link...

Results showed that by the end of the two-year treatment, patients’ scores on the MDS-UPDRS Part IV, assessing motor complications, showed a change of -2.4 units in patients previously treated with placebo, -3.5 units in patients who took amantadine immediate release, and -3.6 units in patients who had deep brain stimulation.
In patients who were already on Gocovri, changes in MDS-UPDRS, Part IV scores were less pronounced — only 0.4 units — confirming the therapy’s effectiveness even before long-term treatment.
“The completed Phase 3 open-label study further expands our understanding of the benefit/risk profile of GOCOVRI,” said Rajiv Patni, MD, chief medical officer of Adamas Pharmaceuticals. “The large reduction in dyskinesia and OFF, as assessed by the Part IV score of the MDS-UPDRS, was observed by the first visit at Week 8 and was sustained for two years. This durability is noteworthy given the known progression of motor complications.”
Gocovri’s safety profile is in line with previous reports. The most common adverse reactions included falls, hallucinations, peripheral edemas, constipation, and urinary tract infections, but these were generally mild to moderate. During the two-year study, 9% of the patients discontinued the treatment due to adverse effects, and nine patients died, although no death was linked to Gocovri.

https://parkinsonsnewstoday.com/2018/04/24/gocovri-improves-dyskinesia-over-long-term-parkinsons-phase-3-trial/

Will new trials change w/RWE? Considering A2-73 safety record and the state of current successes by comparison, will trials be shorter? Will A2-73 safety and efficacy allow/drive changes in trial models?