@DocMcstuffins
Telling us how to suck eggs again.
Controls are used for BOTH safety AND efficacy.
And there are policies and circumstances behind the requirements which to date have been applied to phramceuetical drugs and not the situation here with unmet need and deaths.
You need to brush up on what the policy is there and why the FDA is failing the unmet need of the orphan situation.
read up on what @otherperspective has to say and read back and actually try to comprehend the context for what I'm saying too.
Including the need to reform the FDA which is cumbersome and pernickety.
A bit of homework for you.
CEO Itescu needs to go, page-411
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