UPDATE : Friday, September 22, 2017
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Ocular Therapeutix under probe for faulty manufacture
  • By Marian Chu
  • Approval 2017.07.13 10:42
  • comments 0

A U.S. law firm is looking into investor claims regarding Ocular Therapeutix’s faulty manufacturing and testing practices that led the U.S. Food and Drug Administration’s to reject its drug a second time Tuesday.

Ocular said Tuesday the FDA rejected its new drug application for Dextenza a second time due to not having responded to “referenced deficiencies in the manufacturing processes and analytical testing discovered in the May 2017 inspection.” Dextenza is a post-operative steroid drug for the eye.

The company said Wednesday that the FDA issued “inspectional observations” regarding the company’s manufacturing and analytical testing procedures.

Investors called for an investigation into the company. “Even a layperson reading this can tell that the company is having serious manufacturing issues, and their whole approach to manufacturing and patient safety is highly questionable,” one investor said in a protest letter. “What's more troubling is that either management doesn't fully understand the (FDA) letter, or they have been misleading investors. Both are bad.”

Stock prices plummeted following the company’s second rejection, falling from $7.60 to $5.10 at closing on Tuesday.

Source: Yahoo! Finance

Girard Gibbs LLP, a U.S. law firm specializing in securities litigation to correct abusive corporate governance practices, is investigating the potential claims.

yjc@docdocdoc.co.kr

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