yeah I'm no regulatory expert but I take from this that the whole "conditional " approval is now trumped by the fact that FDA accepts proteinuria as a surrogate for full approval. So you can't have two bites at the cherry, use a surrogate AND get it approved conditionally (that's my interpretation, could be wrong). I also worked out what 2 year data they'll have by August. You have to know how many had been dosed 2 years before August 2025, means by August 2023. the nearest I could find from company comms was late July 2023 they said they'd randomised and dosed 72. That means the most patients there could be with at least 2 years of data by August 2025 is 72 or maybe just a handful more. That's not a lot.
DXB Price at posting:
35.5¢ Sentiment: Hold Disclosure: Held
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