(Total Views: 508)
Posted On: 11/07/2022 3:07:59 PM
Post# of 154133
In my opinion, it was negligent to file the BLA and miss a few sections or fail to double-check the work before filing. However, when the FDA responds with a letter that is literally a road map on how to correct the errors and after two years you still fail to correct them, that's gross negligence or intentional sabotage. When your failure to perform becomes deliberate, that's gross negligence and reckless disregard. Full stop.
Not maintaining or properly compiling the data such that three independent auditors find it beyond repair, that's proof of gross negligence, especially considering managing that data was the ACTUAL service Amarex was supposed to provide under contract.
Continuing to bill for services NOT rendered is fraud. If Cytodyn can prove fraud or malice, that's when punitive damages can be awarded.
Not maintaining or properly compiling the data such that three independent auditors find it beyond repair, that's proof of gross negligence, especially considering managing that data was the ACTUAL service Amarex was supposed to provide under contract.
Continuing to bill for services NOT rendered is fraud. If Cytodyn can prove fraud or malice, that's when punitive damages can be awarded.
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