As of around 4:50 PM EDT on July 7, 2017, Ocular Therapeutix Inc.’s (NASDAQ:$OCUL) stocks have fallen by 25.05% to $7.12 from its $9.05 opening this morning. The dramatic fall occurred after Adam Feuerstein at Statnews published an article raising concerns over the biopharmaceutical company’s manufacturing issues.
Back in May, Ocular Therapeutix revealed that it had received a Form 483. The Form 483 is issued by the U.S. Food and Drug Administration (FDA) when a company needs to resolve problems found after an inspection by the FDA of a manufacturing plant. When it got the news, management at Ocular Therapeutix said that the company planned to respond to the Form 483 within 15 days — the deadline being back on May 20 — and that they believe another inspection is not needed.
Investors are usually not concerned with manufacturing. Typically, investors in the pharmaceutical industry are more concerned with clinical-trial data before it is submitted to the FDA. Manufacturing is mostly not disclosed or discussed with as much transparency as data from clinical trials because it is mostly seen as a non-issue. However, for Ocular Therapeutix, manufacturing is a great issue. For example, the company’s Dextenza drug was initially rejected last year due to FDA concerns with its manufacturing. While Ocular Therapeutix claimed that those problems have been resolved since then, a different inspector found new problems in May.
Ironically, the news from Ocular Therapeutix about the Form 483 came after pre-approval inspection was granted by the FDA for the company’s eye-pain drug Dextenza. It is expected that the FDA will make a decision on the drug either on or before July 19.
Now what
Investors who trust Ocular Therapeutix’s management can buy its shares at a lower price — there may be a chance of its stocks rising again if the company fixes its problems and Dextenza receives approval from the FDA. However, the cheaper stock price does come with the risk of a further decrease if FDA isn’t satisfied with Ocular Therapeutix’s plan to fix manufacturing problems and — like what happened last year — reject the Dextenza drug as a result.
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