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Post# of 257293
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Re: jbog post# 224925

Thursday, 05/09/2019 12:12:07 PM

Thursday, May 09, 2019 12:12:07 PM

Post# of 257293
<<After all this time are we supposed to believe they just recently decided that a 100u vial is required? At best case they were sleeping at the wheel.
>>

I view it differently. The submission timeline was too aggressive to begin with. As others have noted a 9 month timeline would be typical for a dataset this size for this type of drug so they probably realized they wouldn't make first half of '19 and if not, why not include the 100 unit in this submission as well.

So Browne is not without blame in all of this, but I don't see anything egregious enough to bail or conclude that the excuse is a red herring disguising a much bigger issue

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