FDA cited concerns related to the manufacturing control strategy for variability of delivered dose in the TransCon PTH drug/device combination product
No new preclinical studies, or Phase 3 clinical trials to evaluate safety or efficacy, were requested in the letter
Ascendis will work collaboratively with the FDA to make TransCon PTH available to patients in the U.S. as quickly as possible
Conference call today at 8:30 am ET
Ascendis Pharma will host a conference call and webcast today at 8:30 am Eastern Time (ET).
Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. The link to the live webcast will also be available on the Investors & News section of the Ascendis Pharma website at https://investors.ascendispharma.com. A replay of the webcast will be available on this section of our website shortly after conclusion of the event for 30 days.
https://finance.yahoo.com/news/u-food-drug-administration-issues-110000351.html
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