Expert Interview
Take 2: Eteplirsen Briefing Documents out 4/21/16. Spring has melted the DC snow, has Sarepta's 4 year data done the same to the FDA?
Ticker(s): SRPTA DMD expert that has been following the eteplirsen story very closely. Some familiarity with how Biomarin and PTC's drugs were handled by the agency is also important.
First can we discuss your background in DMD and history with eteplirsen and Sarepta please?
What are the biggest and most important changes in the FDA's documents since the first set was released in January?
Do you think the 4 year follow-up data has made an impact on the agency's view of the drug?
How much of the push back from the FDA in your opinion is about the quality of the data vs. respecting the steps required for FDA approval?
The new documents show that the FDA does not agree with the company's historical control arm. Given the problems with historical controls, and the FDA's arguments, do you think the panel will still put any weight on the data? How would a panel member argue that the 4 year data should have any relevance now?
Looking at these documents would you recommend approval of the drug based on current data? Are there points at the panel that you want to hear more on from the company or FDA that could change your opinion or is it basically made up?
Are You Interested In These Questions?
Slingshot Insights Explained
Expert research benefits investors by giving them timely access to unbiased real world perspectives on highly specialized topics. Slingshot Insights' crowdfunded model makes this access available at a fraction of the cost of other expert networks.
Reason
*Slingshot Insights provides access to information, not investment advice. We work to support you and facilitate access to experts; however we are not responsible for monitoring calls for the disclosure of MNPI. You should obtain financial, legal and tax advice from your qualified and licensed advisers before deciding to invest in any security.
