Good morning ladies and gentlemen. My name is and I'll be your conference operator today. I would like to welcome everyone to the Liquidia conference call to discuss a regulatory update for LIQ861. At this time, all participants are in a listen only mode. Following the presentation, we will conduct a question and answer session.
Instructions will be provided at that time for you to queue up for questions. I would like to remind everyone that this conference is being recorded. I will now hand the conference over to Jason Adair, Vice President, Corporate Development and Strategy.
Thank you, and good morning, everyone. Welcome to Liquidia's conference call to discuss the regulatory updates for LIQ861. Before we begin, let me remind you that today's call will include forward looking statements pursuant to the Private Securities Litigation Reform Act of 1995 relating to, among other things, our expectations concerning next steps in the regulatory review and potential of ASICs one or excuse me, approval of ASICs one. Such statements represent management's judgment as of today and may involve significant risks and uncertainties that could cause actual results to differ materially from expected results. Please refer to our press release this morning and recent quarterly and annual filings with the SEC, which are available at sec.gov or from Liquidia's website at liquidia.com for information concerning risk factors that could cause such differences and otherwise affect the company.
I'd now like to turn the call over to Neal Foward, CEO of Liquidia.
Thanks, Jason, and thank you all for joining us this morning. On the call with me today is also Doctor. Tushar Shah, Chief Medical Officer and Head of R and D, as well as other senior members of our company who are available to answer questions if needed. This morning, we announced that the FDA has issued a complete response letter related to the NDA for LIQ861 for the treatment of pulmonary arterial hypertension, or PAH. Consistent with the press release, the items that led to the CRL were related to the need for additional information and clarification of chemistry, manufacturing and controls, or CMC, data pertaining to the drug product and device biocompatibility, as well as a delay in the preapproval inspections related to COVID-nineteen.
Liquidia is confident in our ability to address the items raised in the CRL, and we do not believe they present a barrier to the ultimate approval of '8 61. The FDA also reconfirmed the need to conduct on-site preapproval inspections of two Liquidia manufacturing facilities located in The US. We do believe that some of the items raised in the CRL may have been addressed in the normal course of a preapproval inspection. However, as previously disclosed and has been the case for other companies in our industry, COVID-nineteen related travel restrictions have hindered the FDA's ability to conduct these inspections to date. It is important to highlight that the CRL did not cite the need for additional studies in areas related to toxicology or clinical pharmacology, nor did the FDA request additional clinical studies to further support the approval of the eight sixty one application.
As we recently shared during the third quarter earnings call, we are anticipating a launch in the 2022. We remain confident in that time line as we do not believe that items in the CRL will change that projection. We remain fully committed to working closely with the FDA, and I am confident in our team's ability to provide them with the information required to support the approval of eight sixty one. We continue to be excited about the opportunity in August. This excitement is supported by the strong set of clinical data that we have released over the last eighteen months with now more than 70 patients who have received eight sixty one for more than two years and by their choosing.
We will stay true to our course and firm in our commitment to advance eight sixty one to these patients. And now operator, we are prepared to take questions.
Thank you sir. I show our first question comes from the line of Serge Belanger from Needham and Company. Please go ahead.
Hi, good morning. Thanks for taking my questions.
Sure, sir.
First one, Neil, can you
just talk about the next steps here? Is it meeting with the FDA and just getting clarity? And if you can provide any clarity on the CRL issues related to the drug product and device biocompatibility.
Sure. We'll be glad to, Serge. I will, for all of the folks, I'll probably defer at the beginning here in the questions to Tushar. And I'll let Tushar take that, and I'll add as appropriate. Tushar, you want to take these?
Yeah. Thanks, Neil. So Serge, the the kinds of of items that they're asking when we talk about drug product and device biocompatibility are you know, these are the typical sections of a CMC portion of an NDA where you have a drug and a device combination product involved. And, as you know, we've been working with the FDA through the information request that they've been providing, on these CMC matters. And, you know, we have been addressing them.
Obviously, there are a few items that we weren't able to address to their, satisfaction at this point. But the challenge we have is there's no opportunity for dialogue Right? So we now know where the areas are that are still open, and we will, you know, request an FDA meeting as quickly as we can and, make sure that we have full understanding and clarity of what they want and that the information we're providing is gonna address their concerns. And as I said, you know, these are all CMC related matters.
So, you know, the good news is there's no clinical concerns. There's no areas on toxicology or confirmed. These are the areas that typically take much longer in time to resolve. So we're very confident that these CMC questions can be resolved well, you know, within the time frame that we've stipulated as to when we would expect to launch the product late next year or late in 'twenty two.
Serge, only other thing I would add to that, we'll move to get that meeting set up with the agency as quickly as possible. Obviously, we've got the holidays kind of ahead of us here a little bit. So it'll be probably a little bit tricky navigating that. But we'll seek to do that as quickly as possible.
Okay. Then just a couple of follow ups. So it sounds like they've completed the clinical review portion of the data in the NDA. And then Yeah. Any idea of when the preapproval inspections can be completed?
So at this stage, because we've received a CRL, when we submit the response is when they would FDA would then we would anticipate they would look to do the inspections. I think with the pandemic, as you know, they've been very challenged to do these. We anticipate a lot of companies are struggling. And in the best case scenario, we would have anticipated sometime mid next year would have been the earliest they would probably get to an inspection. And and so it's hard to project exactly, but that would be our expectation that once we submit the response, we would be then in the queue to get the inspection done.
Thank
you.
I show our next question comes from the line of Georgie Yodonova of Cowen and Company. Please go ahead.
Thank you so much guys for taking my question. So I just have a couple from us. So I guess can you also remind us, following up on the previous question, where the manufacturing sites are located? Are they in The U. S?
Sure. And then I have just a a follow-up on, on the CRL and the location.
Sure. I'll I'll take the first one, and and and we'll stand by for your second one. Sure. The the two sites are in are indeed in The US. One of those sites is at our facility here where we manufacture particles, an active ingredient to to kinda create the powder.
That's here at Research Triangle Park in North Carolina. The other site is in Florida where we conduct all of our packaging. So they're both domestic here in The US.
Got it. And do you anticipate the, resubmission to be a type one or a type two?
So maybe I can take that, Neil. I I think Sure, Tisha. We we anticipate obviously, normally, you wouldn't know until you submit the response. The FDA takes a look at it and then determines what classification they're going to grant. We anticipate it's a type two response or a class two response, and and so that's kind of our expectation.
But we won't know for certain until we submit the information that they reviews it.
Got it. And just for the, I guess, upcoming litigation in court, can you just remind us of your confidence in your manufacturing process and how it's different from the patents that are being asserted by United?
Yes. Maybe I'll have I know Sean Glynn, who's our counsel, is on the line here. Sean, would you like to handle that question?
Yeah. Sure. Hey, Georgie. This is Sean. So we have not given obviously, with the with the the private information and the litigation and our litigation strategy, you know, we need to keep a lot of that information very quiet.
So to the details of your question, we have not released that information to this time. But but we will point you to the the fact that, you know, this is treprostinil. It's a drug that's been designed and developed in the seventies and eighties by Upjohn, and then it's worked its way through GalaxoSmithKline and finally into, the treatment of PH later on the early two thousands. So this drug has a lot of history, and there's a lot of prior art on the on the on the drug itself. That's that is about the extent of the information that we're giving us at
this point. Thank you.
Thank you so much. This is helpful. Thank you.
Thank you. I show no further questions in the queue at this time. I'd like to turn the call back over to Mr. Dare. Please go ahead.
Thanks. Thanks. One of our analysts was able I'm sorry, Neal. One of our analysts was So able stay on the I'm going to ask a couple of questions on his behalf just to be transparent. So one of the questions was how long does it typically take for the FDA to accept the revised NDA and take an action?
And I guess that HR might be the best to answer.
Right. So just to clarify, there's not a we're not resubmitting an NDA here. Right? It's just a response to the CRL. And and as I explained, we believe this will be considered a class two response.
So we would anticipate that it would be about a six month review for the FDA, though we won't know for certain whether it's Class I or II until they receive the response and they have a chance to review the materials.
Thanks, Tushar. And then one other question was relating just to further clarify what is meant by the phrase device biocompatibility.
Sure. So device biocompatibility refers to data that we provide in an NDA describing how a device and the materials of the device specifically perform when in contact with the human body. And as you know, this device has been developed and approved for other products for twenty plus years and is still available globally for use in inhaled products. The FDA's requirements on biocompatibility is evolving as many times things do as we learn more about, different aspects of drugs and devices. So, we're providing you know, the FDA is just wanting to ensure that we are up to date with the information we're providing around biocompatibility, and we're working with our device manufacturer to provide the information they're requesting.
Thanks, Tushar. One last question was, how does Liquidia plan to communicate with investors from this point going forward related to the regulatory interactions?
Maybe, Neil, you want to take that one?
Yeah. I mean, listen, as, clearly, as, you know, we continue to learn and evolve it, you know, two charts hit on several things here today around, you know, is this gonna be a one or a two in terms of review cycles, things like that? Those things will remain to be kind of seen, as we go. So, like we always try to do, we will be very consistent in handling any investor questions that come up. And to the extent that we can handle those live time and answer them, we always will seek to do that.
The only thing I'd say is we're obviously digesting, the process here right now ourselves. And so we'll seek to meet with FDA, as quickly as possible, as we mentioned, and begin to dive in. So, but again, I want to bring it back around. We feel all of these items are addressable. It does not impact our timeline for launch on the '2, and we look forward to bringing August to the market.
Thanks, Neal. I didn't have any other questions from our analysts that couldn't stay on the call. So I think that concludes the question section.
Okay. Terrific. I guess I'll just close by saying thanks to those of you who joined the call today. We appreciate the interest and investment in liquidity in some cases. And we'll continue, as I just mentioned, to update everyone on our progress.
And I will take this chance to say I hope everyone has a safe and great Thanksgiving. Thanks for your time this morning. Bye.
Thank you. Ladies and gentlemen this concludes today's conference call. Thank you for participating. You may now disconnect. Good day.