Although the options for accelerated FDA pathways have recently expanded, the current political climate has increased scrutiny of expedited approvals. Next week, my colleague Bethany Hills will be moderating a panel discussion in our Boston office about the realities of pursuing an accelerated pathway. Panelists from J&J Innovation, Synlogic, and Analysis Group will focus on the risks and potential rewards of the shorter time to market.
Topics to be covered include:
- When to consider an alternative pathway to approval
- Risks – including the chance of FDA denial
- Market perceptions — increased value, rising stock prices
- Realities of the pathways
- Clinical and data risks
- Pairing exclusivity and accelerated pathways
- Finance theory on risk and stock pricing
The event will take place next Thursday, March 29th at 5:00 PM in our Boston office (registration starts at 4:30). For more information or to register or the event, please click here.