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Complete Response Letter Mitigation

Preparing Your Launch for a Complete Response Letter (CRL) Contingency 

No company wants to receive a complete response letter (CRL) as it can translate into lost sales and negatively impact a company’s valuation. Unfortunately 40% of novel drug applications in the first half of 2022 received a CRL. With reputations and revenue at stake, companies need to be prepared to react to a CRL and respond in a timely manner. It is important to work with a launch partner experienced in preparing for, and responding to, a potential CRL. 

It is important to keep in mind that a CRL is not an outright rejection of the application and does not mean that the drug can never be approved but requires additional information to be submitted to the FDA to address the concerns listed in the CRL. On average, a company that receives a CRL experiences a delay in product approval by approximately 12-14 months with approximately 7 months to submit a response. Download this paper to get the analysis of CRL trends and learn tactics to mitigate and minimize the impact of a CRL.  

In this paper we share:

  • Significant trends in CRL responses over the last 5 years
  • Mitigation Strategies to Avoid a CRL
  • Planning scenarios to minimize the impact of a CRL

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Herspiegel is a leading professional services firm helping biotech start-ups and the world’s largest pharmaceutical companies navigate the path from science to brand performance and change patients’ lives. We are committed to using strategic insights from medical to commercial to market access to solve critical problems.