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sentiment_stocks

09/12/24 10:40 AM

#719589 RE: dennisdave #719585

I do think that an MHRA MAA approval will help with an FDA MA; which is one important reason I suspect they are waiting to submit.
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Doc logic

09/12/24 10:58 AM

#719599 RE: dennisdave #719585

dennisdave,

Peers have seen the alternative to patient level data in what NWBO presented with their SAP and published their approval of methods used. The Europeans agreed/approved and FDA posed no objections to the SAP. We are seeking approval with MHRA. For now the subjectivity of FDA holds no sway and that is all that matters.. for now. Best wishes.