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nidan7500

12/14/17 8:09 AM

#134288 RE: Talon38 #134273

If the FDA gets behind using 2-73 as a low cost prophylactic for a number of CNS diseases and 3-71 and the rest of the Sigma-1 pipeline prove effective....."Katy bar the Door" by the end of the decade.

Just an old pilots view from 30,000 feet!




What are we going to do about the FDA? After all the sweet talk and big promises about changes we get UUGATZ/NADA/ZIP. Unless they say something right away about the CNS guidelines w/5 CNS trial examples their credibility is zero. No real leadership visible...WHY? Did BP$$$$ and the system get in the way of change? I suspect that is exactly what happened and when a LEADER (Gottlieb)was supposed to step up and get in the face of big$$$$$ he folded like a bad suit.

It does look like BIG WW $$$ is going to be put on the table and I hope the hell we are at the front of the line with our hands out b/c we earned it.

Will the WW CNS crisis dawn on media-politicians and intervene to change all the best of plans by BP? It just was made clear that the WW(read US) regulatory bodies are incompetent and in the way, IMO. They better get their shat together. We either get the FDA CNS declaration in the next couple of weeks and get trials like RETT going or the guys w/the biggest pile of $$$$ are going to end up in complete control, if they are not already.