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Another Opinion: 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 Corinne Keet - MD
Institution: Johns Hopkins
- Associate Professor of Pediatrics in Pediatric Allergy/Immunology at Johns Hopkins School of Medicine with a specialty in pediatric food allergy.
- Treats 100-200 peanut allergic patients.
- Serves as a NIH-funded primary investigator in studies of the prevention, treatment and epidemiology of food allergy and other allergic diseases.
Please describe your background treating peanut allergies.Added By: c_admin
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: c_admin
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: c_admin
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: c_admin
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: c_admin
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