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Innovation Pharmaceuticals IPIX
(Total Views: 218)
Posted On: 01/09/2018 1:26:57 PM
Post# of 72447
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Posted By: Drano
AXON screws up again. This is what happens when you release your stats too soon, before they've been triple-checked.

https://endpts.com/axovant-that-positive-p-va...20up%20too

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Today, the company led by CEO David Hung followed up with the extraordinarily embarrassing admission that it managed to incorrectly report the p value for the one clearly positive endpoint they had touted as a sign that the biotech’s second drug, nelotanserin, was worthy of a pivotal trial.

Instead of mining a positive endpoint from the data on nelotanserin, post hoc, they had another fail to explain. And it was bad.

Tuesday morning Axovant put out a release that their post-hoc subset analysis of Parkinson’s patients with a baseline SAPS-PD score greater than 8.0 (n=19) showed that a 40 mg for two weeks followed by 80 mg for two weeks did indeed result in a 1.21 point improvement.

But…

That p=0.011 figure they posted was wrong. In fact, it was an infinitely worse p=0.531. Instead of finding some reason for hope, the data indicated Axovant had even more reason to doubt success. And instead of going to the FDA looking for guidance on next steps in investigating the drug for dementia with Lewy bodies (DLB) patients with motor deficits as well as patients with more severe baseline psychotic symptoms, they’ll be sticking with DLB.














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