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bernsta

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16/08/17

21:51

Post #: 26546271
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Originally posted by AlCp ↑

March 31 2017 - 524 patients enrolled.
31 patients had pneumonia **The results for diagnosis of bacterial and atypical pneumonia should be considered as preliminary due to the low number of patients (14 and 17 respectively) considered.

June 22 2017 - 1127 patients enrolled (so double in 3 months and is now inline with the sample size required for the US clinical trials) and used US-centric case definition following published guidance by the US FDA, the key measures of positive percent agreement (PPA) and negative percent agreement (NPA) are reported instead of sensitivity and specificity.
123 patients had pneumonia so nearly 3x more diagnosis which now gives RAP a very good sample size, accuracy did drop from 90% to 80% but number increased by 3x.......and more importantly.

"Previous studies have used ResAppDx to diagnose one disease from another. This is the first study where ResAppDx has been used to diagnose a full range of respiratory diseases among a group of patients with a variety of ailments, which is a much greater challenge than previously reported. The excellent results achieved reaffirm the performance of ResAppDx and give us a great deal of confidence as we enter the analysis phase of SMARTCOUGH-C and prepare our de novo submission to the US FDA,"
said Dr Tony Keating, CEO and Managing Director of ResApp Health.

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What's your point?

The study failed and there was no contingency. 12 months have been lost.

All the best.

RAP Price at posting: 6.6¢ Sentiment: None Disclosure: Not Held
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