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Posted On: 04/04/2022 12:26:05 PM
Post# of 148899
Amarex is responsible for following up each AE/SAE that is reported - both to the IRB and the sponsor (CytoDyn/Amarex) - with the IRB during trial closeout, or agreed upon periodicity.
The aggregate safety data across all the LL trials *was* Amarex's responsibility to collect and report. Whether it was done correctly, timely, and accurately is anyone's guess...but judging from the FDA FAERS database there were only COVID related safety events reported and no others. Where are the events from the Cancer, NASH, and HIV studies that Amarex and the local IRBs were involved in?
Either the FDA has a bad reporting system that they can't keep their data correct, or there seems to be a VERY widespread lack of required safety reporting by the local trial site IRBs.
I'm leaning to that the FDA has a dysfunctional data collection/distribution/reporting system that does is not crossing departmental lines...at least for what is shared with their constituents - aka "John Q. Public".
The aggregate safety data across all the LL trials *was* Amarex's responsibility to collect and report. Whether it was done correctly, timely, and accurately is anyone's guess...but judging from the FDA FAERS database there were only COVID related safety events reported and no others. Where are the events from the Cancer, NASH, and HIV studies that Amarex and the local IRBs were involved in?
Either the FDA has a bad reporting system that they can't keep their data correct, or there seems to be a VERY widespread lack of required safety reporting by the local trial site IRBs.
I'm leaning to that the FDA has a dysfunctional data collection/distribution/reporting system that does is not crossing departmental lines...at least for what is shared with their constituents - aka "John Q. Public".
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