That makes sense. You are probably correct. It d
Post# of 154858
(Total Views: 364)
Posted On: 10/10/2019 2:25:47 PM
That makes sense. You are probably correct. It doesn’t makes sense to start the mono protocol if the fda is waiting for safety to see if 700mg dose is fine. Is there any doubt? We say the January data with no ramp up with side-effects versus dose, if anything the 700mg dose has less.
It’s like the FDA can’t believe it and wants the full safety data on the higher dose just to reconfirm what we already know. Once they finally get that, I suspect the rest will go much smoother.
It’s like the FDA can’t believe it and wants the full safety data on the higher dose just to reconfirm what we already know. Once they finally get that, I suspect the rest will go much smoother.
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