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After failing the Primary endpoint in its PEPITES Phase 3 trial, DBV is moving ahead with an FDA filing. Does the drug have a chance at approval?Ticker(s): DBVT, AIMT
Name: Dr Christina Ciaccio - MD
Institution: The University of Chicago
- Acting Chief of Allergy/Immunology and Pediatric Pulmonary and Sleep Medicine, Associate Professor of Pediatrics and Medicine, and Clinical Director of the Food Allergy Program at the University of Chicago.
- Treats on average 3 peanut allergy patients each day and is in clinic 3 days/week.
- Research focus is on determining influences of allergic sensitization and advancing the treatment of food allergy through clinical trials.
Please describe your background treating peanut allergies.Added By: joe_mccann
What is your initial impression of the PEPITES data? Does a 35% response vs. 13% response for the treatment arm vs. placebo look compelling to you?Added By: joe_mccann
The company is touting the success on the secondary endpoint of cumulative reactive dose of 900mg vs. 360mg for active arm vs. placebo. This increase from baseline was stat sig with a p value of <.001. Does this result look clinically relevant to you?Added By: joe_mccann
Safety and tolerability was in line with Phase 2b results. Do any adverse events or safety issues stand out to you given the level of efficacy seen?Added By: joe_mccann
If you were on an advisory panel for the FDA and there were no major surprises in the additional data presentations, would you recommend approval based on the established profile?
Why or why not?
On a scale of 1-10 how excited for Viaskin in peanut allergies are you after this data?Added By: joe_mccann
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