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kld2

04/30/17 2:04 PM

#4424 RE: SF Wolf #4419

I don't know much about it, wolf, but while I was following the discussion on this board the same thought came to mind: FDA is not shy about expressing safety concerns, as we know. And we severely demented elderly to boot.

XenaLives

04/30/17 2:12 PM

#4426 RE: SF Wolf #4419

I didn't know that - following this for educational purposes only.. so isn't it likely the change from 6 mos to 3 mos was based on safety issues?

Again, I my best expectation is that this drug will only be for late stage/ hospice to make the goodbye a little better.



As you well know there was a safety module in the Ph2b study.

The Data Monitoring Committee, (DMC) an FDA mandated component of the Neurotrope study, would have picked up on any drug safety concerns with the AD patients.

If there were serious concerns they would have intervened and changed the study protocol or halted the study.