DXB 5.13% 37.0¢ dimerix limited

So just to dumb this down for laymen like me @IndexInvestor - is...

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    So just to dumb this down for laymen like me @IndexInvestor - is your key message that the results of the interim analysis next March (or futility analysis if this is a more accurate term) aren't guaranteed to be replicated in the final readout of results. And in fact may require better results at the final readout (or a larger patient population) to compensate for the fact that an interim analysis has been undertaken?

    I got a little bit lost with conversations over the past couple of days but that's what I'm taking out of this.

    The Phase 3 Duplex trial for FSGS by Travere for Sparsentan is probably a good analogy of the stats in your example. Their interim results showed 42% of n=190 patients achieved FPRE (greater than 40% reduction of PCR) on Sparsentan versus 26% on placebo (Irbesartan) at Week 36. Then on final readout only 38% of n=371 patients achieved FPRE on Sparsentan versus 23% on Irbesartan at Week 108. But this was still considered meaningful and statistically significant despite being 10% lower than the interim results. Unfortunately they failed to meet a separate primary endpoint for eGFR slope that wasn't reported at the interim stage. But it still demonstrated that the interim analysis didn't harm the effectiveness of the trial design for the PCR endpoint.

    I'd really like to think that we hear more information about results next month other than just that we're proceeding to the next milestone though. I think the magnitude of PCR reduction is going to be the key for translating to a meaningful benefit to eGFR slope and that's ultimately what the success of this trial will hinge on. If I knew that the majority of patients were seeing a combined PCR reduction on DMX-200+Irbesartan of well in excess of 50% then I'd feel a lot more confident going into the next milestone for the eGFR slope endpoint. Wouldn't be guaranteed as your stats point out. But would definitely reduce the risk from my point of view.
 
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