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FDA Mycapssa Snub Whacks Chiasma; New Study Needed

This article was originally published in Scrip

Executive Summary

The FDA tried to warn Chiasma Inc. in 2014 its single-arm, open-label Phase III trial may not be enough to pass muster for the agency to approve the company's new drug application (NDA) for its investigational acromegaly drug Mycapssa (octreotide) and pointed out having a controlled trial would be a better option.

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