Well.... We know MSB have introduced a new ( second ), potency assay, and we know they had to gather a lot of additional ( new ) data regarding that assay. That would include shelf product as well as trial and EAP results with respect to this other assay. Unfortunately this is extremely unlikley to be a simple 2 month tick in the box in my opinion. The potency assay is the cornerstone of the product, and FDA need to do their own data analytic correlation between the assay and trial results / shelf stock etc.
Well.... We know MSB have introduced a new ( second ), potency...
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