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Re: Investor2014 post# 173471

Sunday, 12/02/2018 10:04:20 AM

Sunday, December 02, 2018 10:04:20 AM

Post# of 458545
We will probably never know who actually pulled the trigger. A consensus or not. But, the close timing to Dr. Gottlieb taking control, the nucleation/cluster of BP trial withdrawls from the Amyloid Thesis shortly after that, the timing of this guidance doc soon after along w(MY GUESS)...the FDA said they will no longer support (spend $$/limited resources on) trials that needed many, many years and which to date produced nothing of consequence. BTW, they were already aware that AD testing based on cognitive criteria was highly suspect. If individual sponsors pulled out, so what, other BP would continue if they had promise. In fact, other BP would love to be the last man standing, if they had a winner. IMO, the FDA told them if they keep going, the FDA will not protect them any longer.

In other words Amyloid thesis AD trials presented a big expensive effort that was about to blow up in their collectives faces. IMO, this is only one piece to the FDA's troubled pattern. We will probably never really know the truth but my sense is they are all politicians at the end of the day.
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