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: Thomas Kerr - Zacks Investment Research, Inc - Analyst
: A question on the FDA submission, the substantive review process. Is that the only step? Or are there steps after that? Or can they ask for additional
information? And kind of what is that review process entail?
Question: Thomas Kerr - Zacks Investment Research, Inc - Analyst
: So could an approval best case be in the second quarter of 2025, but normally expected in third quarter of 2025? Did I get that right?
Question: Thomas Kerr - Zacks Investment Research, Inc - Analyst
: Yeah. Okay. No worries. Any update on the Taiwan launch? Is that going as planned? Is it business being done there?
Question: Thomas Kerr - Zacks Investment Research, Inc - Analyst
: Okay. And then one more, and I'll get back in the line. The loan proceeds, the $5 million that's in restricted cash, did that come out of restricted
cash in the fourth quarter because you submitted the application? Am I understanding that right?
Question: Thomas Kerr - Zacks Investment Research, Inc - Analyst
: -- I didn't hear any other questions. I'll jump back in, if that's okay. Can you explain and provide more color on the PuriFi pump sort of program? Is
that just a usage trial type? Or is it going to be marketed more extensively? I didn't quite understand if it was sort of a trial phase or how that's
going to work?
Question: Thomas Kerr - Zacks Investment Research, Inc - Analyst
: Great. That clarifies that a lot. One more quick financial one. The gross margins, you said return to normal in the fourth quarter. Does that mean
low 70s? Or could there be a drag or high 60s? Or can you define normalized at this point?
Question: Thomas Kerr - Zacks Investment Research, Inc - Analyst
: So that will happen in 2025 is what you're saying?
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