Based on my understanding, NP previously said they
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Posted On: 03/19/2020 2:15:39 PM
Re: SouthernGold #22262
Based on my understanding, NP previously said they have data in both formats (A & 
and will be able to submit within a few days of FDA decision. My take after today's call is that the FDA wanted it submitted in C format and while they have all the data available, Amarex is compiling it for the 3rd time in the final format requested by the FDA.
BTW, CMC is manufacturing (ACG stability data). Clinical data is what was pending FDA guidance and being accomplished by Amarex. I'm sure you knew this, just trying to avoid others from being confused.
and will be able to submit within a few days of FDA decision. My take after today's call is that the FDA wanted it submitted in C format and while they have all the data available, Amarex is compiling it for the 3rd time in the final format requested by the FDA. BTW, CMC is manufacturing (ACG stability data). Clinical data is what was pending FDA guidance and being accomplished by Amarex. I'm sure you knew this, just trying to avoid others from being confused.
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