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CherryTree1

05/13/16 7:08 PM

#61568 RE: exwannabe #61566

OK - we agree - the FDA does at times jump in - that is all we've been saying.

I am not aware of any trial where the FDA has jumped in w/o either a submitted NDA/BLA or "concern".

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sentiment_stocks

05/13/16 7:08 PM

#61569 RE: exwannabe #61566

Thanks exwannabe... much more helpful.

So am I understanding you correctly that BMY had submitted data that they were blinded to for AA on Opdivo?

Can you explain how BMY would be blinded to the trial data while submitting for AA?
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Doc logic

05/13/16 10:28 PM

#61593 RE: exwannabe #61566

exwannabe,

Did either of those trials have open label supporting evidence or a chance to verify benefit with anything like UCLA's assay?