It appears this letter was addressed to the CRO, who was being paid to collect the data and submit it. NP wasn't personally sitting there putting it all together. This is why companies hire CROs. This is why CROs get paid big bucks. The level of incompetence is astounding, but the finger of the FDA doesn't seem to be pointing at NP. It seems to be pointing at Amarex. What am I missing?
Was CYDY getting what they paid for? It appears not. Is some of that on NP? Yes, without a doubt. Was Amarex hired to compile the information and submit the BLA? Yes. It appears Cytodyn was right to stop payment. Vendor not performing and costing valuable time and resources is unacceptable. Good luck, Amarex, winning this case.
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