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.
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An investor looking at Aradigm stock for initial due diligence might close that tab right away after looking at its price history.
The latest hopeful investors in Aradigm saw the stock price crushed in a P3 failure in November 2016; the stock crashing from $5.24 to as low as $0.78 - now $1.43.
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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.