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Whalatane

07/31/25 4:53 PM

#668 RE: theswordman #666

Thxs Interesting . So they have enrolled over 100 patients . These patients have to be followed for 90 days ( the composite endpoint ) ...so by the end of Q3 they should have the data on all these 100 patients ...correct ?
If they have data on all 100 patients and if its close to the pediatric data ...chances really increase for a stop
JMO
Kiwi
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Whalatane

07/31/25 5:07 PM

#669 RE: theswordman #666

So the 100th patient enrolled was roughly May 13th[
quote]

The NEUTRALIZE-AKI protocol specifies that an interim analysis will be conducted by the independent DSMB on the primary endpoint of the trial when approximately 50% of patients (100 patients) achieve 90-day follow-up

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So by August 13th roughly the 100th patient will have completed the 90 day follow up ...then its on to cleaning and checking the data .
FDA could ask them to expand the trial ...that would take $

Kiwi