Slingshot members are tracking this event:
FDA has requested the submission of new data and analyses from the MODIFY I and MODIFY II clinical trials. PDUFA date extended to Oct 23 2016
Do you think this event is important to the companies below? How will it affect their stock price?
|Impact on Stocks
|MRK||Community voting in process|
The FDA granted Priority Review designation to the bezlotoxumab BLA, with an original PDUFA goal date of July 23, 2016. On June 9, the Antimicrobial Drugs Advisory Committee of the FDA voted 10-to-5, with one abstention, in support of bezlotoxumab as showing substantial evidence of efficacy and safety in preventing the recurrence of C. difficile infection.
Slingshot Insights Explained
Oct 21, 2016
Don’t see a project related to the catalyst you care about?
Related Keywords Clostridium Difficile, C. Difficile, Infection Recurrence, Bla