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: Carly Nicole Kenselaar - Citigroup Inc., Research Division - Analyst
: This is Carly on for Yigal. We had one clarification question on the heart failure NDA. Can you just walk through what needs to be done in order to
correct this technical issue and resubmit the NDA?
Question: Carly Nicole Kenselaar - Citigroup Inc., Research Division - Analyst
: Okay. Great. And then where do you stand with ex-U.S. partnership discussions for heart failure? Could you broadly characterize the level of interest
you're receiving there?
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FEBRUARY 28, 2022 / 1:00PM, LXRX.OQ - Q4 2021 Lexicon Pharmaceuticals Inc Earnings Call
Question: Carly Nicole Kenselaar - Citigroup Inc., Research Division - Analyst
: Okay. Got it. That's helpful. And then if I could just ask 1 more on the pain trials. We're curious if there's any reason mechanistically to believe that
LX9211 would be more likely to show a therapeutic effect in PHN or DPNP.
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: This is Daniel for Jessica Fye. A couple of clarifying questions on the technical issues found in the NDA submission. Were the site monitoring visits
that were not included related to manufacturing, quality analysis or some other sites?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Clinical. Okay. And was the visit completed by the FDA but not recorded in the NDA? Or was the visit not completed by the agency to begin with?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Got it. Okay. And was there a potential to correct the issue while the NDA is -- was still in submission? Meaning would the FDA have considered a
correction of the technical issue as a major amendment that was not the reason why it was pulled?
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Great. One last question on this issue. How did you detect this issue before the FDA?
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FEBRUARY 28, 2022 / 1:00PM, LXRX.OQ - Q4 2021 Lexicon Pharmaceuticals Inc Earnings Call
Question: Daniel G. Wolle - JPMorgan Chase & Co, Research Division - Analyst
: Okay. Got it. And a bigger picture, when we think about the shift in time line for potential NDA resubmission to early 2Q and launching -- potential
launch in first half '23, what are some of the considerations to keep in mind regarding cash runway?
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