Expert Interview
Legal opinion: Will Avadel be able to launch FT218 in a timely manner (YE21/early 2022)?
Ticker(s): AVDL, JAZZA lawyer with regulatory experience of these types of situations. Preferably someone who has been following this case.
Have you been following the current situation between AVDL and JAZZ ?
Do you have a clear belief as to whether FDA will ask AVDL to certify?
What is that belief based on?
Other there many precedents that closely align to this case? What was the outcome? Please go through both claims brought by JAZZ as to why they believe FDA will force AVDL to certify, and their legitimacy.
If AVDL is successful in gaining timely FDA approval, what options do JAZZ have to try and delay the launch of FT218? What do you believe the chances of JAZZ being successful may be in this scenario?
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