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Re: jbog post# 16740

Saturday, 02/18/2017 11:01:45 AM

Saturday, February 18, 2017 11:01:45 AM

Post# of 20689
Jog, what are you talking about? You said<<This isn't a parental drug so the sterility is somewhat relaxed. >> Of course its a parenteral drug (e.g. not administered by the alimentary tract). To suggest there are two standards of sterility is also not correct. Its like saying someone is a little bit pregnant. Its either sterile or not. This is not going to be a small easily correctable problem in my opinion. It makes them look like a bunch of amateurs with so much at stake. This can't be their first rodeo. Teams that anticipate FDAs every evaluation have to have gone over all this stuff first and yet we have a fail. Shameful. It will be an interesting conference call.. Lets hope we are not entering a world of alternative facts. bp