After some negotiations , FDA agreed to have 3 mon

After some negotiations , FDA agreed to have 3 months stability test ..

Until then they had 11/2 year of stability test for 175 mg ..
Since they were not sure what dose will be use , 525 or 700 mg , FDA asked them also for stability for 350 mg ..,
700 mg is use as 2 x 350 mg dose ..

I am sure about that because during CC I asked this Q Dr NP to make sure we understand well ..

3 months time was ending sometimes in November , so to prepare papers they said they be ready in December ..

I don’t know what is a delay now , but I think maybe some other things not stability test , this I believe is not that complicated for reputable company to prepare ..
But I don’t really know for sure ..