Based on the premise that nothing happens around here by accident, we are cloaked for reason(s).
Dr.M. has been bitten in the past by misspeaking/other. What he learned( I think) is ,"you are not paranoid, they really are after you". Has to do with the incentive to keep a low profile as long as you can. All of BP/WS hacks/other FUD generators will react w/massive force when AVXL pops the (any) news. They all have their asses on the line after decades of one expensive failure after another. So, to the extent he can, he will keep a cloak of silence until the ducks are all lined up and well supported.
With a very small staff he cannot afford to be overwhelmed by fights and attacks which will certainly happen when he pops the cork. Our opponents are skilled and well armed. Evidence like pre purchased A2-73 inventory, backup financing, trials diversified by geography and by indication, notices of winning MOA publications pending, new staff hires for key US jobs. You could each write your own list but you see quickly that these are not the planning moves of a nothingburger organization. They have the data and the goods but they have to wait until the evidence is absolutely bullet proof b/c the BP/Political/regulatory/financial/academic world will come unglued when they see what we have. He cannot afford to spend his time fighting worthless attacks, which are certain to happen. This holiday week usually is a silent period in my experience.
There it is, it is just an opinion but it all fits for me. It is not a theory that lends itself to BIG jumps in sp but at some point (as trial results warrant) I think it will all make sense. I believe he sees the scope and value of the CNS cellular Homeostasis properly and it is bigger than we, or anyone, can swallow at one sitting. It will have to prove itself over time, but we have all the evidence needed to get it started. We'll see I guess and it is driving me nuts.
BTW, no obligation to agree or not, just a theory in support of what is going on. I also think this is fundamentally an unstable position which will/must resolve itself soon. An expression from Miyamoto Musashi comes to mind..."In battle, you must fight as though you were already dead." the code of a warrior. He is doing it his way and I support that, as difficult as it is.
Fast track is just expediting the paperwork on the approval.
Accelerated (U.S.) or Provisional (AU) would be preferable because it would put the drug on the market on substantial but not conclusive evidence with P4 testing.
These are the programs that Anavex should be applying for.
Note that both the Rett and PDD readouts would yield evidence to support the MOA in Alzheimer's.
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