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Tuesday, October 04, 2022 11:56:32 AM
There are examples including large pharmaceutical drugs. They are not indexed so calling on people to provide you with examples is pointless. It’s all part of complex back and forth and even searching for it is very challenging but I debated the issue a few years ago where it was maybe Merck, that had approved a special protocol assessment even on their initial SAP, but they gave that up because they needed to revise the SAP based upon the realities they discovered along the way. They were still blinded, as I recall.
And as for post hoc allegations, those are false and FDA regulations explicitly address revising the SAP and what makes such revisions most clearly valid, is submitting prior to unblinding.
You can claim their were “unblinded”, but a Federal Court decision dismissing a claim, on these very matters, says you’re wrong.
And as for post hoc allegations, those are false and FDA regulations explicitly address revising the SAP and what makes such revisions most clearly valid, is submitting prior to unblinding.
You can claim their were “unblinded”, but a Federal Court decision dismissing a claim, on these very matters, says you’re wrong.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
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