I think we are past that phase now ( a decade ) with the FDA boxed into a corner with few options left.
No wonder certain people left the FDA upon seeing this as it could get ugly if they continued the delays on poorer and poorer excuses. Defending such in a court case along with huge donations to lone dissenting votes could be a nightmare.
The delay, ironically, has resulted in strengthening MSB's assay moat could end up being the real revenue generator in the long run.
banter and General Discussion, page-9481
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