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Tuesday, April 17, 2018 3:33:12 PM
Dr. M knows this, has chose this path for a reason with the BOD and is breaking his way through ice at the FDA to get these trials into smooth sailing water on the other side.
Agree that closely managing the FDA relations, trial structure, pass /fail criteria and other aspects of the sponsor-FDA interface must be a lot more complicated than expected. When little or no facts are leaked and complex processes go down paths that citizens/shareholders had no reason to think even know existed (PD dementia vs/before RETT) then SURPRISE happens. IMO, there has got to be a better way to keep us informed while not spilling the beans and taking risks.
My suggestion:
There is a trial/cycle plan /schedule linked the home page...use it. We shall see what was discussed at the ASM, one way or another (jones has the ball). We are not stupid, tell us what is going on, we can handle it. The massive GAP between total silence and getting sued is filled every day by other Bio firms. Please figure out how to communicate so that some trust is built. We can do this.
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