Nader doesn't have to pass a language course or the Mr. Universum competition. And FDA is not his supervisory board or a main shareholder to qualify the results of the company.
The drug is top class with respect to all relevant parameters for approval. Name me one single argument against approval? Just one!! In my opinion for matters of deaths pvalue doesn't count when clinical results are phantastically. Yes, p-value counts for irresponsible bureaucrats.
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