Anavex Life Sciences Corp (AVXL)

[nidan7500]

http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220180360796%22.PGNR.&OS=DN/20180360796&RS=DN/20180360796

As I have pointed out before, this patent app. (w/hypothetical sequence) describes the process an outpatient will follow while being treated w/A-27 for AD. The consortium presents the configuration and resources needed to operationalize this new treatment methodology, and to apply it to other NMS indications. The AD patient scenario described here allows the patient to be serviced as a clinic outpatient w/certain restrictions. (leave that thought there for now).

The ERP Biomarker Qualification Consortium was launched today by pharmaceutical industry members with the goal of qualifying event-related potential (ERP) biomarkers to aid the development of new investigational therapies for people with schizophrenia in accordance with FDA guidelines1. The Consortium, which brings together industry, academic and regulatory stakeholders, also aims to standardize ERP measurements so they are consistent across treatment centers and can be used to stratify patient populations and evaluate the effects of new treatments.

Principal industry members of the Consortium include Alkermes, Inc. (ALKS), Anavex Life Sciences Corp. (AVXL), Cadent Therapeutics, H. Lundbeck A/S (LUN.CO, LUN DC, HLUYY), Merck (known as MSD outside the United States and Canada) (MRK), Neuronetrix Solutions, LLC (dba Cognision), Sage Therapeutics, Inc., and Takeda Pharmaceutical Company Limited (TAK).

The consortium allows a clear headed rethinking of CNS trial methods using electronic devices specifically designed and configured to perform data gathering tasks while compiling EHR and DHR objective evidence. You may ref. FDA guidance docs I have posted describing their being "Reborn" w/electronic data gathering instruments. BTW, these are not gadgets, they are devices which have been produced and tested in clinics specifically for this purpose in verified FDA compliant manufacturing processes. The S/W systems and the configured H/W have been validated by FDA agents for this purpose. These are basic requirements of medical devices for H/W and S/W. They cannot be used in trials where decision affecting patient decisions are taken. They will each be registered Class II medical devices as such.

The professionally driven consortium will directed to design and evaluate/sponsor the development of CNS indication specific H/W, S/W (Bio-Chem-micro treatment) which will be unique to each indication and likely will be patient unique based on Precision Medicine driven Biomarkers. The key here is the A2-73 treatment(Homeostasis driven Dr.M. vision) which only Anavex has. He owns the secret sauce that makes this entire thing possible.

So, we can see the dots getting lined up and it is a beautiful thing to watch. The Consortium will provide resources and capability while Anavex provides the sauce. Obviously, this kind of Consortium would not happen w/o the SAUCE and the common belief held by a lot of smart people that they will make this work. The dark days of the shotgun trials are over. Science will drive now. This is a little like the transition from analog to digital technology that happened in the 70's. There is no going back, that's the good news. All the doubters are in deep shat and they should see that, anyone who has been through it can sense it. I see that in many exceptional thoughts posted here.