Our focus is no longer on getting FDA approval from the CD12 results. My hope is that we get very good interim results from at least one of the two trials in Brazil, and share it with the FDA who may then reconsider granting an EUA. Given the constant emergence of new variants like MU in the US and elsewhere, the Brazil interim results may be an eye opener for the FDA and everyone else, and the timing may be very good for the next variant.
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We did not meet the primary nor secondary end points, bad trial design? Sure, but the results are the driving catalyst for approval here. The FDA is not going to give us any type of approval based on that, period.