Saturday, September 15, 2018 2:21:45 PM
It still makes me so angry at the FDA for not allowing the protocol for the mono trial originally - this whole combo trial and the mono being investigational is on the FDA for slowing everything and costing us millions. The fact that the FDA created the BTD treatment is purely to speed up their in-efficient process. To hold it back to the point where it's benefit is practically nothing is a joke. What drug/disease do they think is more important to give BTD and make this a top priority?
I guess given the history, maybe Nader's enthusiasm is what we need the most. To be honest - if I had to listen to the FDA and their beurocracy the sailor language would be flying and I would have thrown in the towel likely.
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