The whoosh we need is the sound of the management and the CEO in particular being swept out the door. This is unlikely as this company is renowned for rewarding incompetence. The Vivagel fiasco was not a black swan event anyone who understands the US knows that it is the apex feeder and when you ignore them by giving your business to an Italian company and bought for Uncle Sam you should realise that you needed to hire that FDA expertise during the submission not get them as firemen after the event.
Chuck her out!
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