$ADMP some longtime posters here may remember numerous self proclaimed "pharma experts " saying that a 5 mg dose would never get approved. It's too high, unsafe , cardio pulmonary issues! Never going to get approved! Apparently the FDA disagrees. No safety or efficacy issues were raised. The ONLY concerns seem to be in quality and manufacturing, which can be specifified and remedied. Just a matter of time now. It may happen sooner than many "experts" think, imo.