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ChrisMissing

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ChrisMissing

Re: WolfofMia post# 414391

Tuesday, 05/09/2023 7:46:03 AM

Tuesday, May 09, 2023 7:46:03 AM

Post# of 459553
So maybe what we are reading is that they have had discussions with the FDA or other agencies and they guided to a P4 confirmatory trial. and once they have the full data set ready for discussions with regulatory agencies, they will look for Accelerated Approval Pathway.
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