Yes, of course Whytee you are right. BSI set all the protocols for both studies. OSL meet them and prove the device is safe. BSI then ask OSL to submit a further study of 20 patients for safety and efficacy. Guess what? OSL goes one better and submits 42 patient study. Over double what was asked. The study shows the device is safe and it works!
But no that’s not enough for BSI. They then set up a new process with the COC panel who knocks it back!
BSI is the problem not OSL! OSL don’t need to set up a new study to prove safety or efficacy.
While BSI stuff around with even more bizzare requests, patients who could benefit from the OSL device miss out!
This is absolutely disgusting. BSI should be ashamed of themselves.
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