Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) Q4 2022 Earnings Call Transcript

We expect as being the only randomized controlled study ever done in Mycobacterium abscessus. We think that this study will be instrumental to shoring up NUZYRA’s inclusion in the NTM abscessus treatment guidelines as well. The third component of our strategy is where you were getting towards is what can we do with the study from a regulatory perspective, particularly in the U.S. And we will, as you suggested, once we have the data from this study, go back and speak to FDA. And I continue to believe that if the data is robust from this study, combined with everything else that we’ve continued to generate over time, including preclinical data as well as the large number of case series that continue to get published on NUZYRA use in NTM abscessus.

I think we have a good position to talk to FDA about its potential to be included in labeling. That being said, they still obviously have the ability to request another Phase 3 study. We have not contemplated that to date as a company. And I think as we get further into these regulatory discussions, we could consider what that might look like. That being said, now that we have clarity from Japan on what a Phase 3 study in Japan and the rest of the world may look like, I think, although not being a primary endpoint of symptom response, that study as well, will certainly provide additive support for any discussions we have with the FDA.

Ed Arce: Great. Thanks Randy. Appreciate it.

Operator: As there are no further questions at this time, I would like to turn the floor back over to the CEO, Evan Loh for closing comments. Please go ahead.

Evan Loh: Thank you, operator, and thank you all for listening in today. We look forward to keeping you apprised of our continued progress. Goodbye for now.

Operator: This concludes today’s Paratek Pharmaceuticals conference call. You may disconnect your lines at this time. Thank you for your participation, and have a great day.