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Post# of 108192
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ignatiusrielly35

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ignatiusrielly35

Re: ubmmg post# 99995

Wednesday, 06/19/2019 10:41:41 AM

Wednesday, June 19, 2019 10:41:41 AM

Post# of 108192
I am not the first person to fault the FDA for being slow and inefficient and I won’t be the last. And it is not limited to affecting ADXS. Why did ADXS (most likely Mauro) design the trial this way? It is not a matter of simply unilaterally designing a trial when you apply for SPA. There is an ongoing discussion/negotiation with the FDA in arriving at what is approvable. So there’s your answer.
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  • 1D
  • 1M
  • 3M
  • 6M
  • 1Y
  • 5Y
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