So , what has changed !27 Sep 2022 11:25
IMO , the FDA are slow walking it’s decision making, asking for more detail on xenon gas make up , according to the last CRL,there no mention of xenon problems , after all , there are several major hospitals including one in Oxford trialling this medical device. We must comply with FDA but again I feel POLX are harshly treated, providing all data and the kitchen sink ,to prove it’s reliability, the very best of luck to RH and his team.on Friday.
PJ