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nidan7500

05/13/22 10:13 AM

#360259 RE: boi568 #360252

boi568

Why is this application not patently obvious (pun intended)? Doesn't every doctor adjust medication?



Good question. Are you aware of any specific A2-73 treatment /applications/tool suite manual now in use WW? Such a manual -treatment guidance will note specific time/intervals for analysis, results records requirements, instruments./controls on maint/calibration. Any lab records of -computer system validations being performed for the specific work being done, compliance of those systems w/FDA regulations.

We could go on but you see the point.

My belief and the basis for my positive reaction to this Patent app is that FINALLY after decades of very sloppy work a disciplined process w/specific industry/regulatory guidance is being put ion the table by serious adults who expect to get results. How the FDA continued for 30 years and billions of dollars w/unlimited smart-hard working staff allowed management to deliver no credible CNS disease solutions,... and they still kept their BIG jobs. All while pts and families hoped and waited...being told ...No effective treatment is available.

I am delighted that Dr.M. and staff have taken on this critical responsibility. It is obvious the established system is flawed.

Now, we have a tiny little Bio firm whose leadership has the stones to step forward w/a specified trial protocol(s) using precision methods . This patent app. will mean a lot and likely also for dedicated MD/staffers who work every day to make a difference. Having a document process w/good controls , strong training and records and a plan on how work will be done/measured/assessed and acted on matters in any process.

The Medical-pharma system needs a little ass kicking from time to time, like all process based businesses. This may be the start of a new set of studies and disciplines. IMO.

IMO, Dr.M. and AVXL team are basically taking the left seat, PIC.