Given the FDA denial, I thought that it was strange that the FDA did not mention any Back Trial issues when BIEL submitted it for their advise in the Pre-Submission Package.
It would be worth having an FDA experienced lawyer compare the FDA Back denial to FDA regulations and precedence. As you mentioned, if BIEL had not had experienced counsel in the Knee/Foot 510k the FDA would have denied the application.
Unfortunately that is the way the world works. If you do not have the clout/experience to deal with a government agency you had better hire somebody who does or they will walk all over you.
I like the sound of 'the biggest retailer in the world'. Working with the 'Big W' would mean lower margins but if they can generate the volume we are still good.
>>>There will be an announcement from the company once confirmation is made for the FDA meeting in 2019.<<<
Is it fact that there will be a FDA meeting between the parties again in 2019? Has this already been stated by company or FDA? Don't recall hearing this. Or is this just a hopeful opinion?
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