RE: Crystal Equity Research publishes initial report on IQ-AI Ltd1 Jun 2022 20:08
This is an extract from the report. I really dont know why the company couldnt have set out the schedule for FDA response within the RNS. Very poor. I think the FDA have to respond within 15 days to say they have all they need ,and then the 3 months kick in.
Thanks very much for you two posters sharing probably the most detailed report I have seen.Worth another read I reckon. Cheers Extract below
IB has recently prepared a pre-market 501(k) application to the U.S. FDA, which is expected to
be submitted in the near-term. The application claims IB Zero G is safe, effective and
substantially equivalent to a legally marketed device. IB leadership expects a favorable
response within three months, enabling commercial introduction of IB Zero G before the end of
2022