Esperion Therapeutics ESPR

luckypt

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Esperion to Present at the 38th Annual J.P. Morgan Healthcare Conference

The PDUFA (Prescription Drug User Fee Act) goal date for the completion of the bempedoic acid NDA review is set for February 21, 2020, and the PDUFA goal date for completion of the bempedoic acid / ezetimibe combination tablet NDA review is set for February 26, 2020. These dates are consistent with our expectations and reflect the standard review period. The FDA has communicated that there is no current plan to hold an advisory committee meeting to discuss the applications.

ottima opportuniità, stranamente molto ferma.
 

luckypt

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Esperion Announces Positive CHMP Opinion for the Marketing Authorisation Application

Esperion Announces Positive CHMP Opinion for the Marketing Authorisation Application for the Bempedoic Acid / Ezetimibe Fixed...

The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit. The European Commission will review the CHMP opinion and is expected to adopt a final decision in April 2020. The decision will be applicable to all 27 European Union member states plus the United Kingdom, Iceland, Norway and Liechtenstein.
 

1_fede_1

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nessuno la segue? hanno delle pasticche per il colesterolo senza statine :) mica male