Ocular Therapeutics Inc (NASDAQ: OCUL) is having a rough day in the market today, there’s no doubt about that. However, the declines actually all happened last night when the company received a Complete Response Letter (CRL) from the FDA surrounding Dextenza. Today, the stock has actually been finding its way upward from the bottom. This begs a big question, “Is this a buying opportunity?”
FDA Offers CRL Surrounding Dextenza
As mentioned above, Ocular Therapeutics isn’t off to the best of starts in the market today, following massive after-hours declines in the stock yesterday. The declines were ultimately the result of a CRL released by the FDA surrounding Dextenza. Dextenza is an ocular steroid that is designed to give the patient a full course of steroids after an operation.
In the letter, the FDA informed OCUL that they were unable to approve the treatment as of yet, offering up key points that need to be addressed before an approval can happen. In response to the CRL, Amar Sawhney, Ph.D., CEO, President, and Chairman at OCUL, had the following to offer:
“We are evaluating the FDA’s response and plan to work closely with the agency in an effort to satisfy the requirements related to the NDA… Importantly, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication. We believe that DEXTENZA can be approved once these open manufacturing items are resolved.”
Is This Really A Buying Opportunity?
In my opinion, the declines that we saw last night do indeed present a strong buying opportunity. The reason is relatively simple. The FDA didn’t reject the treatment because of anything that had to do with safety or efficacy. In fact, the treatment proved to be effective and relatively safe. The issue the FDA had with the treatment surrounded manufacturing. At the end of the day, these are very easy issues to resolve in the grand scheme of things. Ultimately, there’s nothing wrong with Dextenza, and OCUL knows it – the problem is in manufacturing.
As a result, I would go out on a line and say that chances are that Dextenza will eventually find its way to approval. As a result, we find ourselves in the midst of a waiting game. However, while we wait, we might as well earn, right? With OCUL trading on incredible lows and fear being high, now is the time to strike if you have the stomach for it!
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to follow OCUL incredibly closely. In particular, we’re interested in following the company’s continued work to bring Dextenza to the market. We’ll continue to follow the story closely and bring the news to you as it breaks!
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