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catdaddy

03/30/26 8:08 PM

#516572 RE: Steady_T #516570

And the ADL miss will be thrown out by the FDA.
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Investor2014

03/30/26 9:01 PM

#516573 RE: Steady_T #516570

To judge the merits of that idea we need to understand what exactly the mythological issue are that made CHMP have a negative opinion also at reexamination.

Adding OLE and post hoc in-trial findings is not going fix what is likely fundamental issue with the RCT.