(Total Views: 564)
Posted On: 04/08/2021 9:25:21 PM
Post# of 154635
“Everyone talks about hitting a p value for EUA”
I agree, we should have enrolled more in the LH trial. Time will tell.
In terms of hitting p-values for EUAs or approvals - I am coming to the belief that EUAs and approvals are given based on a combination of objective (p-values, trial size, etc.) and subjective (company stability, technical competence, demonstrated quality/assurance, etc.) criteria. In other words it takes both numbers and trust. We need a drug that works (objectively) and a company that can literally manage the process (subjectively) like people’s lives depend on it.
We can argue till we are blue in the face if this is right/wrong, good/bad, virtuous/evil, done consciously or subconsciously - but I suspect there is more to the approval (EUA or full) process than we as outsiders (or anyone on this board) really understand. The question for Cytodyn is how do we prove both the objective and subjective components of the buisness to get approval?
Read More: https://investorshangout.com/post/newpost/605...z6rUl2ChAm
I agree, we should have enrolled more in the LH trial. Time will tell.
In terms of hitting p-values for EUAs or approvals - I am coming to the belief that EUAs and approvals are given based on a combination of objective (p-values, trial size, etc.) and subjective (company stability, technical competence, demonstrated quality/assurance, etc.) criteria. In other words it takes both numbers and trust. We need a drug that works (objectively) and a company that can literally manage the process (subjectively) like people’s lives depend on it.
We can argue till we are blue in the face if this is right/wrong, good/bad, virtuous/evil, done consciously or subconsciously - but I suspect there is more to the approval (EUA or full) process than we as outsiders (or anyone on this board) really understand. The question for Cytodyn is how do we prove both the objective and subjective components of the buisness to get approval?
Read More: https://investorshangout.com/post/newpost/605...z6rUl2ChAm
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