The FDA is asking for MOA and batch consistancy data to put a halt to the cowboy outfits that will seek to copy MSB.
This will form a big moat for MSB once done.
Yes it may also be a delaying tactic which enriches big pharma meanwhile but at least there is some legitimacy to the arguments used.
The clock is ticking on that however and in a few months time the FDA will be out of excuses.
Rem-L Needed NOW, page-4
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