(Total Views: 546)
Posted On: 02/17/2022 4:50:08 AM
Post# of 148878
Re: Cassandra X #118351
I think it is very difficult for AMAREX to argue that this big mess is the result of only a few employees work. They must have some internal quality processes and a kind of internal project audits which would have uncovered this huge pile of s*it. Especially, if they get kicked in the as* by FDA several times over such a long period, certain quality managers at AMAREX must have been alerted immediately of such blunder.
If they did/ do not have any kind of quality management, then I would classify this as gross negligence. But I doubt this very much, since NSF would have checked the processes at AMAREX extensively prior the take over. They did not buy a black box.
NSF took over AMAREX in October 2019, at this time they already had filed the first part (non-clinical portion) of the HIV BLA in March 2019. The other two parts were filed in April 2020, when NSF already owned AMAREX for more than 6 months.
Either AMAREX is and was a pile of sh*t and NSF did not recognize this (doubtful) or the mess was intentionally by AMAREX and we will hopefully find out how deep the rabbit hole is.
Based on what we already know, I would not be surprised if at one point the RICO act comes into play.
If they did/ do not have any kind of quality management, then I would classify this as gross negligence. But I doubt this very much, since NSF would have checked the processes at AMAREX extensively prior the take over. They did not buy a black box.
NSF took over AMAREX in October 2019, at this time they already had filed the first part (non-clinical portion) of the HIV BLA in March 2019. The other two parts were filed in April 2020, when NSF already owned AMAREX for more than 6 months.
Either AMAREX is and was a pile of sh*t and NSF did not recognize this (doubtful) or the mess was intentionally by AMAREX and we will hopefully find out how deep the rabbit hole is.
Based on what we already know, I would not be surprised if at one point the RICO act comes into play.
(5)
(0)
Scroll down for more posts ▼