Ann: Path Forward For Resubmission of MOXDUO NDA , page-15

re: Ann: Path Forward For Resubmission of MOX... Massive over reaction? I struggle to see how could the AC not recommend approval where on all counts this is a safer and more effective drug (albeit a combo of two existing drugs)? Is there scepticism as to what drug they would switch to if there was an adverse reaction given it may be one or the other (or both)? Surely, this happens with a lot of other drugs and there are usually substitute drugs available (obviously not in all cases). Whilst another poster showed the AC has a 50/50 approval rejection ratio, it would be puzzling to see how they could reject MOXDUO and QRX should be leaving no stone unturned to ensure that absolutely every t is crossed and i dotted in their re-submission. I'm holding still. A huge amount of valuable IP and potential health benefits would be lost of they strike it down. GLTA