Didn't they only say FDA Approval expected by the end of this quarter (quarter ending in June)? Anyways, this is purely my guess, so take it with a grain of salt.. Because of the nature of 3 base technology in which Cytosine is converted into Thymine and the converted genome is different from the normal CGTA based genome that any approving body including FDA, TGA, CE, etc need more information and takes longer for them to approve.. Even getting TGA was quite slow on this and that was my thought back then. Just wait and there's no reason why FDA won't come
Bell Potter's top picks for FY21, page-14
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