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Posted On: 04/18/2021 8:40:26 PM
Post# of 148884
Re: ClosetInvestor #87070
“13. 14:14 “First one- We can simply add more patients to the Open-Label of CD12 that we have, and recalculate the p-value until it is less than .05. Is this acceptable by regulatory agencies?”
Is it acceptable to continue on this path without knowing if it is acceptable to regulatory agencies? I think it is clear that it is not acceptable to US FDA. I believe NP's hope is that the Philippine FDA might accept it. Hope is a poor strategy at this late stage.
Is it acceptable to continue on this path without knowing if it is acceptable to regulatory agencies? I think it is clear that it is not acceptable to US FDA. I believe NP's hope is that the Philippine FDA might accept it. Hope is a poor strategy at this late stage.
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