KK's Statement..."neither He or others at
Post# of 148198
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Posted On: 04/20/2024 9:29:08 PM
KK's Statement..."neither He or others at AMAREX.... believed that the FDA would reject the application"...Hook is in...belonging to SA on who was in contact with the FDA...throughout process.
"KK reasonably believed that to the extent there were any deficiencies in the BLA...the FDA would send requests for additional information...rather than outright reject the application."
This per KK's assertion... that this was according to their (FDA's) own protocol.
This is pretty much what happens ...when you catch a fish...it flip flops.
"KK reasonably believed that to the extent there were any deficiencies in the BLA...the FDA would send requests for additional information...rather than outright reject the application."
This per KK's assertion... that this was according to their (FDA's) own protocol.
This is pretty much what happens ...when you catch a fish...it flip flops.
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