After all, it closes the chapter on whether the da
Post# of 155577
(Total Views: 571)
Posted On: 11/02/2022 2:26:59 AM
Re: Evil Rabbit #130008
Quote:
After all, it closes the chapter on whether the data was viable for a BLA.
The External Auditor along with all the other Auditors validated the Top Line End Point Results. That data would have been viable for a successful BLA.
On the other hand, the Quality of the Data Management, Monitoring and Overseeing was no where near the mark.
In my opinion, there was no Quality whatsoever, that even came close to what would have been necessary to get the BLA approved. There are no quality systems in place, which need to be followed and adhered to that are integral to get a BLA approved. Therefore, how could it ever have been approved even if there was no problem with data formatting? CAPA and QMS problems were all over this and Amarex could do nothing to fix it. Amarex was either unfit for the work or it was purposefully sabotaged. Either way, they and all those connected are done.
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