It would be nice to see Congress get involved and overhaul the dysfunctional FDA and make it responsive and relevant ... oh, who am I kidding. Cue the laugh track. The entire Imperial City is a racket with headquarters on K Street. The people running the FDA will be looking to score a payday with BP somewhere down the line, just as former congressmen make their score on Wall Street after dutifully bailing out the crooks at GS and the others. The Generals retire to their score 'consulting' for Boeing or the other MIC racketeers. Or they become talking heads for Fox or CNN, providing valuable insight on our never-ending wars. And on and on.
Sadly, the FDA as a whole will never change until the whole system goes 'belly-up', at which point, many people will suffer. However, pressure can still be applied in targeted cases. The best thing that Prana has going for it Tanzi's high profile. You give the guy these high and prestigious honors, and you give him leverage. You build him up to be the Edward Teller of the race to cure AD, and even the creeps in DC are forced to listen. If Tanzi decides that the most important roadblock to success is bureaucratic rather than scientific, then maybe you start to use that leverage on the movers, the shakers, the politicians. And you use the popular media. He's very good at that. I have no problem with him being a 'celebrity scientist' if it helps the cause. Carl Sagan showing up on the Tonight Show certainly was good for the NASA budget.
Why is the FDA blocking PBT2 when there are no safety issues after years of human trials, and its likely benefit in young HD patients could be safely received today? What's the potential harm? What's the likely benefit? How much time is being lost in evaluating PBT2 in AD while these inexplicable delays drag on? Does Prana know the answer? Do they think the FDA has legitimate concerns, or do they think it's a capricious or purposeful roadblock?
We're long overdue for a resolution to this roadblock. Either give us some guidance on when the PCH will be lifted, or say you have no idea, and it's up to a capricious, even clownish FDA. The stock price can't go much lower, as all the long-suffering shareholders know, so maybe a little honesty now would be a good thing. How much patience are we supposed to have?
PBT Price at posting:
12.0¢ Sentiment: Hold Disclosure: Held
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