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

Prepare for CRL Contingency

Authors

Everett Lozzi

Manager

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Everett has extensive experience helping life sciences clients to launch and optimize products across therapeutic areas such as neurology, ophthalmology, psychiatry, nephrology, and rare disease. Recent project work includes market access launch support, product value proposition research, and strategic account planning. Prior to Herspiegel, his work at ZS Associates included qualitative/quantitative market research, goto-market planning, and sales/marketing strategy. Everett holds a BA from the University of North Carolina Chapel Hill and an MBA from Duke’s Fuqua School of Business. 

Ryan Subhan

Senior Consultant

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Ryan has extensive experience in content strategy and development for both the patient and HCP audiences. Prior to consulting, Ryan spent 9 years in healthcare advertising where he developed the creative content strategy for numerous brands including TobraDex ST (Opthamology), VYXEOS(Oncology), Namzeric (Alzheimer’s), Zecuity (Migraine), and others. Ryan has worked on multiple launches, developing content for full suites of launch tactics for both patients and HCPs. Ryan holds a BS in Biochemistry from Quinnipiac University and an MBA from Rutgers University School of Business. 

Evan Aftosmes 

Senior Analyst

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Evan has supported projects in Brand Strategy, Market Access, Patient Services, and Financial Management across a wide variety of products and disease states.  His previous experience includes HEOR and Market Access Reimbursement in the medical device industry. Evan Holds a Master of Public Health from the UNC Gillings School of Global Public Health and a BS in Economics from the University of Pittsburgh

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