PROTALIX BIOTHERAPEUTICS, INC. (PLX)

[midastouch017]

Regarding FDA's inspection backlog the US Government Accountability Office (NYSE:GAO) is putting pressure on the FDA to quickly resolve this issue per a March 4, 2021 report. The report states:

"The FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused. These tools include relying on inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing drugs. FDA has determined that inspections conducted by certain European regulators are equivalent to and can be substituted for an FDA inspection. Other tools provide useful information but are not equivalent."

The GAO report further indicates that the FDA is studying the possibility of conducting those inspections virtually such as those being done by some European regulators since 2020 like the UK as an example.