Objective

• A publicly traded, specialty pharmaceutical company was preparing for a PDUFA date in anticipation of an FDA decision for this product candidate. The company had previously received a complete response letter from the FDA for this product candidate, and it was essential that the company’s investor relations strategy be understood by Wall Street

Program

• Crafted the press release outlining announcing FDA approval
• Developed detailed Q&A document of potential questions asked by member of the financial community
• Organized aggressive non-deal road show with investors following approval to discuss planned commercialization activities
• Updated the company’s website reflecting the fact that the company is now a commercial organization
• Updated the company’s IR presentation to include information on the drug approval and outline preliminary commercial strategy and timing

Results

• The product was approved by the FDA and the company’s shares appreciated significantly on news of the approval
• Following the announcement, the company embarked on an aggressive schedule of calls and in person meetings with members of the financial community to review the company’s commercial launch plans