By Introduction
The Control Response Letter
The FDA issues a CRL when it determines that a drug cannot be approved in its current form and requires additional clinical evidence for confirmation. Outlook Therapeutics’ treatment, known as ONS-5010, is an investigational ophthalmic formulation of bevacizumab developed specifically to address wet AMD. According to a statement released by the Iselin, N.J.-based company, they are fully committed to resolving the concerns raised by the regulatory agency.
Addressing the FDA’s Concerns
While the FDA recognized that Outlook Therapeutics’ NORSE TWO pivotal trial successfully met safety and efficacy endpoints, it ultimately decided not to approve the BLA during this review cycle due to several manufacturing-related issues and a lack of substantial evidence. The agency’s observations from pre-approval manufacturing inspections further contributed to its decision.
Conclusion
As Outlook Therapeutics Inc. works diligently to address the CMC issues outlined by the FDA, investors may be concerned about the impact on the company’s stock performance. As of now, the stock has experienced a 71% decline in premarket trading. However, it’s worth noting that despite this setback, the stock has still seen a 30% increase since the beginning of the year, while the S&P 500 has gained 17%.
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