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Tuesday, May 02, 2017 12:01:37 PM
"Is Missling seeking the expertise of this recent hire to explore ANY means or methods to seek something like Special Protocol or Accelerated Testing/Approval or anything that has the blessings of FDA which will help bring 2-73 to the market sooner than the usual defined process steps?"
yes, the FDA insider ought to have a real understanding of what it takes to get accelerated approval, either for Rett after p2, or maybe 6 mos into p3 on alz. very good point, these situations are made to order for accelerated approval, why default to the normal process when we can vault t the head of the class.
"is this a typical hint that Missling is giving us that we can expect a double dose of good news in the next few days that the company is starting the Rett and PD phase 2 trials and has interacted with FDA?"
I am hoping that mr. FDA was brought in to smooth the final steps and get the FDA signoff.
"Anavex, being a micro biotech - both in terms of market cap and number of employees, is trying to make sure that, they get things done right the first time they submit something to the FDA."
Yes this is very big. Show the FDA up front that we are a first class operation, got our ducks in a row. Makes them confident in our ability, professionalism and science. As usual, Missling is covering all the bases and executing according to his plan.
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