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Posted On: 03/07/2021 6:01:34 PM
Post# of 148900
Mrs. Woodcock responded a reddit user (u/fr8trplt) 's inquiry:
I just asked Ms. Woodcock to comment on her interview with BIOPHARMDIVE 6/5/19. Why are we required to continue the trial in light of the impressive CD012 results?
“The FDA hardly talks about this, but we're really talking about what is the cost of failing to approve an effective therapy versus the cost of making a mistake and approving a therapy that is not effective," she said. "There may be thousands of lives to be lost if you delay for another three years or whatever it takes to get more definitive evidence."
"People say they want placebo-controlled trials, but I always ask them would you be willing to die to give a p-value?" she added.
Perhaps a little heat is in order? I just followed her on Twitter. I urge you to do the same.
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I just asked Ms. Woodcock to comment on her interview with BIOPHARMDIVE 6/5/19. Why are we required to continue the trial in light of the impressive CD012 results?
“The FDA hardly talks about this, but we're really talking about what is the cost of failing to approve an effective therapy versus the cost of making a mistake and approving a therapy that is not effective," she said. "There may be thousands of lives to be lost if you delay for another three years or whatever it takes to get more definitive evidence."
"People say they want placebo-controlled trials, but I always ask them would you be willing to die to give a p-value?" she added.
Perhaps a little heat is in order? I just followed her on Twitter. I urge you to do the same.
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