Re: IBB - [showing, but not drawing, scabbard]
Yes, of course we need regulations, standards, and protection, that is not in doubt. But the question being considered is not so much the use of drugs that may not be efficacious, it is about the time it takes to prove safety and the social cost tradeoffs.You can't have your cake and eat it too. Your must evaluate trade offs when costs and delays reach epic proportions, and reviewing FDA behavior is not necessarily to condemn it. My view, after seeing the destructive holds they imposed on 520/521 is that the FDA did not act in the best interest of the public. What do you think about the success ARWR got with humans and chimps versus the problem with the high dose on monkeys? Did that merit the destruction of ARWR DPC effort, and the harm to shareholders? Is that the best way to deal with the WW poblem that cHBV presents? Stop the work that ARWR was doing? I have stong doubts that the FDA acted properly, and suspicions that some corrupt politics played a big role. This experience makes me feel it is time to give the FDA a shake up.