CEO in TELECONFERENCE with FDA confirms this.
Minor manufacturing issue i.e LABELS shall write Instructions as per FDA's REMS recommendations/guidelines..ALEXZA can do this in ONE DAY...is FDA is acting on somebody's behalf ?
May be Yes!! but for some Individuals benifits. But for ALEXZA it is making or breaking point. I hope FDA should also stop playing with COMPANIES LIFE along with PEOPLE while reviewing approval process.
REM's under control....Labelling is MINOR ISSUE!!!!!!!!!!!!