The FDA precedent is there from what was given the nod for retrophin. It's good to see EMA agree to this as they are typically more conservative with respect to such processes than in the US - I don't remember retrophin ever claiming EMA had given them a clear route to conditional approval.
the bigger question is who pays for this and if the asset has a chance of meeting the interim analysis of proteinuria gradient or however they call it. It would be good if someone with more stats knowledge that me that can make some comments about what recruitment would have to look like to be sufficiently powered for a successful interim analysis, based in the Ph2 data
The FDA precedent is there from what was given the nod for...
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