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Re: sts66 post# 34638

Wednesday, 09/17/2014 5:57:36 PM

Wednesday, September 17, 2014 5:57:36 PM

Post# of 430692
sts,

FDA refused to negotiate while the SPA appeal process was ongoing since if SPA exists their evaluation primary has to based on the ANCHOR study and they "have to" approve. Until the SPA appeal process was ongoing they "did not know" ... how could they act regarding the sNDA. Now, they do not have to use the ANCHOR study as a primary basis so they could be flexible. (?): #34552

Why is it still a possibility: #34637

I do not know the real possibility, however this is that I said several times since the CC ...
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