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everyonesguess

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everyonesguess

Re: None

Sunday, 01/20/2019 1:52:41 AM

Sunday, January 20, 2019 1:52:41 AM

Post# of 425904
I read 2013 AdCom Documents once again and thought FDA can make judgements to RI results based on 2013 AdCom's conclusions, such that no need to calling on any new AdCom.

Now, FDA needs to decide a PDUFA date for RI sNDA.
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