McGonegal didn't want to set expectations for the AppyScore NPV in the new phase III study, but I think it's very safe to assume that results from the new study have to improve on the 89% NPV recorded the last time around. Given the changes made to the new study, there is no reason why AppyScore shouldn't perform better.
What NPV score gets AppyScore approved by FDA? Again, McGonegal and Pusey don't have a specific number to throw out, saying that FDA has not set a specific efficacy hurdle for the test.
If I had to make an educated guess, AppyScore's new NPV must exceed 95%, and may even need to reach 98-99%, in order for 1) FDA to approve; and/or 2) for AppyScore to have any chance of being clinically relevant and therefore used by doctors in hospital emergency departments.
Right now, doctors using simple blood tests, patient exams and CT scans to diagnose appendicitis achieve NPV levels north of 95% and even as high as 99%. This is the real-world efficacy bar for AppyScore because if the test on its own can't beat the current standard of care, emergency rooms are only adding cost to the diagnosis of appendicitis without gaining any diagnostic value.AspenBio has, in the past, reasoned that one value of AppyScore could be the elimination of expensive CT scans from the diagnosis of appendicitis. True, in theory, except that AppyScore works by measuring a marker for inflammation. The test doesn't specifically screen for appendicitis. This means that most ER docs would likely still use a CT scan to make sure that it's the appendix and not some other nearby organ, which is in trouble. AspenBio shares, trading around $4.30, have almost doubled in value in the past two weeks, as the stock attracts the interest of retail investors and traders. Some of the information published about AspenBio on blog sites like Seeking Alpha is incorrect or omits key facts, so I'd be careful.
Sticking with Twitter, @bobbandera asks, "Seems Acura Pharmaceuticals (ACUR) has to take niacin out of all their drugs. How much of a delay is that? What's the procedure?"
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