Well ODAC bought it up but the FDA not buying. MSB in my humble opinion have not articulated this regulatory risk that well. It has all become apparent with the ODAC notes from the FDA. Why is that? When did this become an issue?
Happy to be corrected - but when did MSB explain that they may not be abe to satisy the FDA that they can repliacte potency?
And btw - you have been more than having a dig at people in your posts as well. Especially those without an upramp. Your bleating against a serial downramper (who has quite some cred right now given the state of play) does not cut it.
You seem like an angry fool - lashing out but not knowing why you are angry...
MSB to dispute FDA finding in Type A meeting, page-126
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