I'm hoping that the audit of Amarex's records comp
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Posted On: 04/04/2022 2:15:24 PM
I'm hoping that the audit of Amarex's records compared to the local sites' records will demonstrate several things:
- That the sites' data will be the "ground truth",
- That comparison of the sites' data to Amarex's data will show lack of proper process/procedure on Amarex's side...which will hopefully feed into a civil "malpractice" suit,
- That any AE/SAE reporting by the sites will clarify any justified FDA concerns,
- and others that I've not thought of yet...
As for the FDA's records/communications/process/accountability....not sure what they share internally, but the publicly accessible data gives me concern to transparency/accountability issues with the FDA. (yes...I can hear everyone publicly "gasp and clutch their pearls" at that).
- That the sites' data will be the "ground truth",
- That comparison of the sites' data to Amarex's data will show lack of proper process/procedure on Amarex's side...which will hopefully feed into a civil "malpractice" suit,
- That any AE/SAE reporting by the sites will clarify any justified FDA concerns,
- and others that I've not thought of yet...
As for the FDA's records/communications/process/accountability....not sure what they share internally, but the publicly accessible data gives me concern to transparency/accountability issues with the FDA. (yes...I can hear everyone publicly "gasp and clutch their pearls" at that).
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