Friday, January 28, 2011 9:02:21 AM
"What we hope to do is meet with the FDA prior to submitting our package and say 'here's what we're doing, here's what we're gonna give you. Is there anything else you can think of so we can try to push this through to get a 'yes' "
WHAT THE FDA WILL BE THINKING:
"Oh, this moron is trying to bully us, telling us what we need, what we should be satisfied with, what our procedures should be, and to forget any pathway to approval and give him a 'yes' now!"
WHAT THE FDA WILL TELL DEAN:
Mr. Janes, In our NSE letter date stamped Oct 22, 2010, we included a whole list of items that were deficient in your previous submission. Please respond to those deficiencies satisfactorally, and you will get your 'yes' in due time. If you don't, you will get another NSE in due time.
PROBLEM:
Dean can't satisfy those deficiencies, as he knows, as the FDA knows, and as everyone else knows. That's why this whole exercise will be yet another huge waste of time and money.
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