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Doc Logic, rolling submissions must be per section.

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exwannabe Member Level  Saturday, 08/12/17 03:57:06 PM
Re: Doc logic post# 129707
Post # of 130289 
Doc Logic, rolling submissions must be per section. So the entire clinical section (the meat) would be waiting for the results.

The real purpose of the rolling submission is to allow the non clinical stuff to be vetted while the trial is still in progress.

Take a look at typical times for small bios to get approvals post top line data. A year would be good.

The BLA is a large effort. Does not happen in weeks.


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