'Nobody that I can see on hot copper has given a reason we persist with the US and The FDA'
There are many reasons:
- the FDA is viewed as a competent technical regulator around the world regarding product safety and efficacy (as opposed to some other county's regulators)
- FDA approval can lead to an equivalent approval in many other (but not all) markets (e.g. by Australia's TGA)
- European approval may require that trials be run there
- if further trials are required in other countries it will cost many millions and significant time
- MSB has a good professional relationship with the USA being dual-listed there, and many board members are US citizens
There are more reasons.
MSB to dispute FDA finding in Type A meeting, page-725
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