My understanding from NP today was they have all t
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Posted On: 03/19/2020 2:34:31 PM
Re: SouthernGold #22274
My understanding from NP today was they have all the needed data and just needing to redo some data to the format the FDA requested (i.e. C format). I understood the previous data was presented as combo trial protocol (format A) and mono trial protocol (format 
......but maybe the system has a way to submit both formats that Amarex was not aware of (not commonly used) or the FDA wanted to reworked to somehow compile the data differently than they had prepared.
Like trding said, the important part for me was that they have the FDA response (10 days ago) and are moving forward on the final submission for clinical data (the most time consuming and critical to approval IMO). The FDA guidance, submission errors and CMC are the 3 questions between now and approval. The FDA removed one of the question marks and IMO now only submission errors and CMC data need validated for approval.......and I see the FDA as the most questionable as they alone have built the gauntlet that NP has been maneuvering through since the combo trial met its pivotal P3 primary endpoint well over a year ago.
......but maybe the system has a way to submit both formats that Amarex was not aware of (not commonly used) or the FDA wanted to reworked to somehow compile the data differently than they had prepared. Like trding said, the important part for me was that they have the FDA response (10 days ago) and are moving forward on the final submission for clinical data (the most time consuming and critical to approval IMO). The FDA guidance, submission errors and CMC are the 3 questions between now and approval. The FDA removed one of the question marks and IMO now only submission errors and CMC data need validated for approval.......and I see the FDA as the most questionable as they alone have built the gauntlet that NP has been maneuvering through since the combo trial met its pivotal P3 primary endpoint well over a year ago.
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