If accepted by the FDA, Zalviso could offer sufferers and hospitals with an appealing alternative to the existing standard of care, specifically IV PCA-delivered opioids. The NDA submission required payment to the FDA of a $1.95 million NDA filing fee in the 3rd quarter of 2013, which is contained in the Company's income statement as an additional research and development expenditure. FDA regulations allow for the waiver of the NDA submitting fee if the business is filing its first NDA and qualifies as your small business with significantly less than 500 workers. The FDA requested the tiny Business Administration to determine if AcelRx was your small business, and the SBA ruled that AcelRx could not qualify as your small business recently.org with permission from the Henry J.Between 1 percent and 8 percent of sufferers reported that the notes caused them confusion, while a far more substantial minority, between 26 percent and 36 percent, had privacy worries, and 20 percent to 42 percent reported sharing notes with others. Few doctors reported much longer visits or more time addressing patients’ queries outside of visits after access was given. But between 3 percent and 36 percent reported changing the content of notes and up to a 5th took additional time writing them.