The only thing I can think of that would be differ
Post# of 148301
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Posted On: 09/28/2019 7:11:44 AM
The only thing I can think of that would be different is I recall NP mentioning that they needed a decision from the FDA on 525 vs 700 because something was different in the manufacturing process (he stated some technical thing about it) and I wonder if something minor is different in these daises and that is why the FDA needs stability data?
Common sense says that if 700mg is simply two 350mg doses and everything else is the same then it wouldn’t be needed? Hopefully NP provides a little more detail for the additional stability request.
Common sense says that if 700mg is simply two 350mg doses and everything else is the same then it wouldn’t be needed? Hopefully NP provides a little more detail for the additional stability request.
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