RE: MHRA Approval?8 Apr 2022 20:12
yawn, Angle has a US clinic and US clinical staff, and a US ADR and US patents... FDA are snarled up, but my interpretation of the long delay is that FDA have come back to Angle a couple of times over small details, which have needed amending. My sense (and it's only a sense not inside info) from latest email responses is that the final details requested were not completed until quite recently, which is both good and bad - good in that FDA have exhausted their questions, bad in that there will still be a queue for a decision....