Avadel Pharmaceuticals PLC at Evercore ISI HealthCONx Virtual Conference Transcript - Thomson StreetEvents

Avadel Pharmaceuticals PLC at Evercore ISI HealthCONx Virtual Conference Transcript

Avadel Pharmaceuticals PLC at Evercore ISI HealthCONx Virtual Conference Transcript - Thomson StreetEvents
Avadel Pharmaceuticals PLC at Evercore ISI HealthCONx Virtual Conference Transcript
Published Dec 01, 2021
8 pages (4387 words) — Published Dec 01, 2021
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Abstract:

Edited Transcript of AVDL.OQ presentation 1-Dec-21 2:15pm GMT

  
Brief Excerpt:

...Yes. Umer, first, thanks for the opportunity to be a part of the conference. We appreciate the chance to participate. What we've communicated to date is that the FDA informed us back in mid-October that they weren't going to be able to meet the action date of October 15th. And they, quite frankly, needed more time to complete their review and that they wouldn't finish their review in October. So since then, we've not been provided a new action date specifically, just to answer your question directly. At this point in time, based on what we know today and the interactions we've had to date and where the review stands, we don't expect a formal action to occur that would actually result in a new PDUFA date, whether that's a CRL or whether that's a major amendment or those sorts of things that could actually result in a formal date. So at this point in time we believe the review continues to progress, which is exactly what has occurred. And that the FDA is just going to take an action as they...

  
Report Type:

Transcript

Source:
Thomson StreetEvents
Company:
Avadel Pharmaceuticals PLC
Ticker
AVDL.OQ
Time
2:15pm GMT
Format:
PDF Adobe Acrobat
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The following is excerpted from the question-and-answer section of the transcript.

(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)

Question: Umer Raffat - Evercore Inc. - Analyst : My first question to you: do you have a PDUFA date?

Question: Umer Raffat - Evercore Inc. - Analyst : Got it. Greg, my experience tracking FDA reviews is that when it takes longer, it's usually because some new information was submitted at some point in the review. Was there any new information submitted on your behalf?

Question: Umer Raffat - Evercore Inc. - Analyst : Nothing qualifies as a major amendment. Okay. Got it. And I guess, just so you can lay out for a lot of us on precedents on at what point in FDA review does FDA ask for patent certification. What do we know off of other drugs, maybe not even getting to specifically your situation?

Question: Umer Raffat - Evercore Inc. - Analyst : Nothing new to share. Nothing new to share. Got it. So it sounds like your confidence around the whole strategy remains intact.

Question: Umer Raffat - Evercore Inc. - Analyst : Got it. Okay. Excellent. I recall you guys did mention you received some questions from FDA. Could you elaborate on what they are?

Question: Umer Raffat - Evercore Inc. - Analyst : Okay. Got it. That makes sense. Eric, anything on the regulatory review before we move on to additional topics around REMS, et cetera? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 01, 2021 / 2:15PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Evercore ISI HealthCONx Virtual Conference

Question: Umer Raffat - Evercore Inc. - Analyst : Got it. Got it. Got it. Greg, where are you with setting up with your own REMS?

Question: Umer Raffat - Evercore Inc. - Analyst : Greg, as I recall in the patent estate, there were really just two sets of patents. One was on -- one was around basically the REMS and the other one was around the second [peak] which resulted in the DDI, if I may. So it sounds like you feel fairly confident REMS is not -- REMS patents are not what is going to hold you guys back. As it relates to the DDI, maybe how would you characterize the ongoing discussions on that? REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 01, 2021 / 2:15PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Evercore ISI HealthCONx Virtual Conference

Question: Umer Raffat - Evercore Inc. - Analyst : Got it. And is it fair to say that some of the information around this was submitted midway through the review, or did you submit that early on in the review to the FDA?

Question: Umer Raffat - Evercore Inc. - Analyst : Maybe, Greg, as we're continuing to progress -- okay. So it was -- so basically, the short conclusion from that is this information FDA did have through the review, they might have asked for more follow-ups on some of this information as the review went on, but they had the initial cuts of the data from the very start.

Question: Umer Raffat - Evercore Inc. - Analyst : Yes. Got it. And there might have been some questions on it further, but they had it. Okay. And as it relates to sort of when the patent -- when you guys do formally get approved, I guess, do you guys see a basis for potentially getting a lawsuit just on your label and on those valproate patent interactions? It wouldn't be a Paragraph IV lawsuit but a lawsuit in general based on the label.

Question: Umer Raffat - Evercore Inc. - Analyst : Okay. Fantastic. Commercial opportunity -- I guess one of the big feedbacks that's quite prominent is that, A, market is moving very fast towards low sodium but also B, that the once-nightly is a more niche opportunity. I think that's at least some of the feedback that's been going around from some of your competitors in the space. I guess how do you guys think about that?

Question: Umer Raffat - Evercore Inc. - Analyst : Got it. Any feedback on payer discussions, Greg? Do you guys think you are going to use some of the rebates and pricing levers? Or are you are going to come in at premium pricing or stay at parity pricing?

Question: Umer Raffat - Evercore Inc. - Analyst : Got it. Eric, any big items we missed that you had on your mind?

Question: Umer Raffat - Evercore Inc. - Analyst : Outstanding. Greg, anything we missed? I want to be very respectful of the time. I know we're right exactly at time, but unless we've missed anything major, huge thank you, as always. Always a great discussion. Superefficient. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. DECEMBER 01, 2021 / 2:15PM, AVDL.OQ - Avadel Pharmaceuticals PLC at Evercore ISI HealthCONx Virtual Conference

Question: Umer Raffat - Evercore Inc. - Analyst : Fantastic. And thank you, again, for being so flexible, Greg. Thank you again.

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MLA:
Thomson StreetEvents. "Avadel Pharmaceuticals PLC at Evercore ISI HealthCONx Virtual Conference Transcript" Dec 01, 2021. Alacra Store. May 18, 2024. <http://www.alacrastore.com/thomson-streetevents-transcripts/Avadel-Pharmaceuticals-PLC-at-Evercore-ISI-HealthCONx-Virtual-Conference-T15054544>
  
APA:
Thomson StreetEvents. (2021). Avadel Pharmaceuticals PLC at Evercore ISI HealthCONx Virtual Conference Transcript Dec 01, 2021. New York, NY: Alacra Store. Retrieved May 18, 2024 from <http://www.alacrastore.com/thomson-streetevents-transcripts/Avadel-Pharmaceuticals-PLC-at-Evercore-ISI-HealthCONx-Virtual-Conference-T15054544>
  
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