lol the advanced BLA process according to various ASX announcements was meant to allow things to get sorted and then bang - CRL for CMC issues and dodgy third party data. Yes the advanced BLA sorted out the BS alright.
My take is the 2nd failure had the FDA advise assay tests were improved but not a tick on the underlying potency issue. stand to be corrected if someone can point out that the FDA actually said otherwise
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