External doctors have little or no influence on FDA decision-making. The only time they do is if the FDA sets up an Advisory Board of leading experts to review the data, vote and make recommendations to the FDA. But even that. the FDA has overruled the AdBoard recommendation. Nowhere in a drug application process are MDs involved other than the AdBoard if there is one.
NICE doesn't care about speedy availability if the drug is not approved. NICE looks at "cost-effectiveness" of the drug which usually means that drug companies need to "drop their pants" to get approved. If the SoC is a cheap generic, it makes it much harder to get approved at a significant price premium like brand drugs normally require.
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