We should be receiving an official notification of receipt of NDA and suggestions of or if further documentation.....Hopefully AFFY new president will promptly keep we shareholders informed of all communication... If Zelmo is right about trial success ie. his location... we have a great chance for early acceptance...Let alone the MONIES that will be saved by gov't programs on this new product... a win for all the GOV"T, FDA and AFFY......and don't forget we shareholders...GLTA
I was under the impression FDA had up to 60 days to accept, or reject and they could reject any time within the first 60 days, otherwise it's considered accepted. I tried unsuccessfully to do a key word search oat FDA.gov on the topic.