We now know why it took more than three months to respond to FDA request for detailed animal test plan: JHU didn't have experience growing the rabbit tumors and as of August update, hadn't grown tumors sufficiently large to test. But reason for delay doesn't matter. To FDA review team, RDGL isn't in a rush, so why should they be in a rush? Just simple human nature. Time will tell what expedited review means after it takes RDGL more than three months to submit plan.
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