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Re: mecosmo2 post# 27477

Monday, 01/08/2018 8:57:55 PM

Monday, January 08, 2018 8:57:55 PM

Post# of 30353
Here's the most important slide from the new corp presentation:

Additional Clinical Efficacy Analysis:
• Assessment of clinical meaningfulness (MCID) demonstrated clinically
important differences across all dosing cohorts
• Anchor based analysis results indicated that each of the 5 potential
anchors met the meaningful change threshold

Updated Safety:
• We believe safety deficiencies from CRL have been fully addressed
Clinical safety profile from phase 3 studies has not changed with
greater than 1 million uses around the world

• The majority of AEs have been mild to moderate, local to the site of
administration, transient in nature with event durations of less than
two hours

Updated CMC/Module 3:
• All the CMC deficiencies from the CRL have been addressed
• Results from successful Human Factors Test were included in
resubmission
• Manufacturing process and manufacturing sites were updated in the
resubmission
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