could it be that one or two items need fixing up, and hence a new date to be given to final approval?
i would expect and demand if FDA have totally knock back our submission, MSB should move to legal action as they have complied with what the FDA wanted (FDA have changed to goal post before), it would look totally corrupt if no approval surely, and huge questions would need to be ask about the role of the FDA as a governing body,
FDA, has to work by their own governance ie does i work and safe,
they should give no governance of cost or delivery of product re cost, they are market consideratioins and the FDA is not an investment advisor.
implicantion from the insurance industry and whehter they will cover what MSB does. ? is whose responsiblity
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