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Posted On: 01/10/2022 11:38:42 AM
Post# of 145881
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I have to back Craig a little here, The relationship a company has with a vendor is different. All vendors start out being totally capable and the client should be able to let them do there job feeling confident to not need to oversee it. However, if a client is in tremendous need that a vendor must do the job 100%, checking their work is needed by them or a third party. Its not that it should be needed, it is that it is wise to do so.
When we learned of Amarex being so incompetent, my first thought is why did Cytodyn not realize this for 2 years? Why did they not do something and not let it end up in the courts? I am sure there is way more back and forth between Cytodyn and Amarex throughout this. I also feel it was likely Amarex was telling Cytodyn they can fix this and it is normal. Cytodyn also likely knew that to fire Amarex during this would set things way back and sticking with them was not ideal but the least worse situation.
We did learn that the FDA likely tried to look past Amarex's screwups as much as they could. However the FDA has to stand by their approvals (I know this seems hard to believe) and the submissions can't be this sloppy.
When we learned of Amarex being so incompetent, my first thought is why did Cytodyn not realize this for 2 years? Why did they not do something and not let it end up in the courts? I am sure there is way more back and forth between Cytodyn and Amarex throughout this. I also feel it was likely Amarex was telling Cytodyn they can fix this and it is normal. Cytodyn also likely knew that to fire Amarex during this would set things way back and sticking with them was not ideal but the least worse situation.
We did learn that the FDA likely tried to look past Amarex's screwups as much as they could. However the FDA has to stand by their approvals (I know this seems hard to believe) and the submissions can't be this sloppy.
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