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Re: avxllent post# 399347

Saturday, 01/21/2023 10:13:01 AM

Saturday, January 21, 2023 10:13:01 AM

Post# of 462250

Beginning to Question When This Happens?

avxllent

Most/many of us have same questions. IMO, the likely/possible explanation for delay would be the complexity of the integrated systems which MUST BE in use. # of notified-certified bodies, number of independent systems used by different regulatory bodies in different countries (even very minor errors will STOP the train. Each one must be verified and validated , including instruments used and reviews of training/certification of every 2nd/3rd party.

The list of what must be done, by whom and when is long and (likely) continuously in flux. I have done such multi national V&V work as many others here may also and would say (countries/languages/hw/sw/v&V of each system ) not to mention patient variables and local/in country practices all are factors in why this type of multi country./multi system /multi regulatory body/international trial is not even attempted (never mind on a CNS disease as complicated as AD) .

My guess is Dr.M.'s answer might be..."It will be published when we finish and not before" ...
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