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The company submitted an NDA in late July, and we should hear back very soon if the application is complete enough for review. Though a quick look gives the impression of a Titanic made from toilet paper, the September 18 KOL call identifies a possible reason for P3 failure: unbalanced macrolide use.
In this article, I will briefly examine the company, drug, and disease.
Interestingly, one of Aradigm's main competitors, the much bigger and better-funded Bayer (OTCPK: BAYZF), had a similar treatment failure in one of its two non-cystic fibrosis bronchiectasis trials, as reported on April 5, 2017.
In this trial, the 14 day on/off trial succeeded, but the 28 day on/off trial failed. The data seemed OK, but not quite there for me to consider more than a trade for a wild risk/reward chance...
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