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Wednesday, December 02, 2015 9:57:24 PM
The only variable is, as you stated, when the review actually started. Typically it's the date when FDA receives the submittal. But clearly, every day, week and month that goes by, the likelihood that this variable is reason for the 'delay' becomes less and less probable.
Also, understand that FDA would never, under and circumstances, tell a company what Andy has said they told him. It's the same thing he said the first time around. 'Decision by XXX date'. That's not how it works. Not at all. Ever. Why? Because there is a regulation that FDA must follow.
I know everyone really wants to believe that this can be explained away...but in the real world the silence speaks volumes.
The product is not novel enough to generate anything, even if it does ever get cleared. The share structure is a disgrace and has been for quite some time.
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