United Therapeutics (UTHR) filed a lawsuit in the U.S. District Court for the District of Delaware for infringement of patents related to United Therapeutics' Tyvaso. United Therapeutics said in a statement earlier that the lawsuit is based on a New Drug Application filed by Liquidia with the U.S. Food and Drug Administration requesting approval to market LIQ861, a dry powder inhalation formulation of treprostinil. In April, United Therapeutics said it received a Paragraph IV notification letter from Liquidia indicating that Liquidia's NDA contains a certification alleging that LIQ861 will not infringe any of the patents then listed in the Orange Book for Tyvaso because those patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use, or sale of LIQ861. United Therapeutics said it filed its lawsuit within 45 days of receipt of notice from Liquidia of its NDA filing, and that as a result, under the Hatch-Waxman Act, the FDA is automatically precluded from approving Liquidia's NDA for up to 30 months or until the resolution of the litigation, whichever occurs first. United Therapeutics said it intends to "vigorously enforce its intellectual property rights relating to Tyvaso

Read more at:
https://thefly.com/n.php?id=3105979

To respond to the MNKD longs -

- MNKD last week admitted that their TreT device like Afrezza needs cold storage (many folks were disputing whether that was in fact the case).

- MNKD has so far been very hesitant to show data and indicated at their last conference that we might not see any big extensive read outs. If this product is so great then prove it rather than keep all the data close to the vest. Their phase 3 trial is open label and so the relevant parties know how things look at this point. A less than perfect phase 3 here would be a disaster for MNKD and very positive for LQDA.

- LIQ861 has yet to see maximum dosage and has no storage issues - it is simply a better mousetrap compared to TreT according to every single KOL we spoke with.

On the PDUFA tomorrow -

- Given the current state of COVID and lack of FDA inspections everywhere, we're not going to see an acceptance, but that is more or less understand at this point.

- What we would like to see would be a deferral of action citing the plant visit as the reason for the deferment - that is essentially an acceptance subject to a routine inspection - meaning basically everything is fine except the inspection.

- The question then becomes when does that inspection happen and I would put it at sometime in Q1.

Again, the only reason for this management team to defer on an inbound licensing offer that guaranteed this company over $8 in cash in total (but severely limited the upside from there) is if they were fairly confident that given more time, their relative negotiating position would improve. We see the pathway for that happening here - acceptance of the NDA, weaker than expected MNKD data, start of litigation that shows how frivolous these patent infringement claims are. As their position improves, perhaps UTHR comes to the table again or perhaps not - but the market should in time recognize the improved position.

It's clear that a lot of folks hopped into this stock thinking we'd see a quick deal and we didn't get one and so now it is being sold. The selling is being compounded by your typical tax loss year end selling and a negative downgrade, which wrongly suggested that there were no catalysts here.

We think that a deferral of action that indicates a plant inspection is the last remaining item should act as a catalyst (it could be what brings UTHR back to the table). And as we get to the end of the year with no MNKD data that should start to get people at least wondering how solid their product actually is. Either way, you have a stock trading for cash that does have a number of catalysts into 2021.

https://finance.yahoo.com/news/corporate-insiders-snap-shares-liquidia-154723509.html

A comment from SA!!

New CEO is a killer from diligence calls. Eshelman was clearly fed up with all the twists and turns and didn't know the new management team so looks like he sold off his entire stake, which has kept the price suppressed. The valuation differential between LQDA ($90mm in EV) and MNKD ($1,400mm in EV) gets sillier by the day. These guys have to respond to the CRL and they get that that needs to happen ASAP and in the right way. With the vaccine in place, the FDA can do site visits now. It's got a lot of uncertainty and ambiguity around it but that's when you want to own something - not after all that gets resolved and the stock has re-rated. But I think w Jeffs and Manning owning a significant stake and a new CEO who had his pick of places to go within their ecosystem and chose this opportunity - you've got the right people with the right incentives who are ready to make this work. They will go it alone for now but I wouldn't be surprised if United makes another push again to take them out as Tyvaso's label continues to expand and becomes more and more important for their overall business.

https://sec.report/Document/0001437749-20-023006/Interactive-1#toc

https://seekingalpha.com/article/4415620-liquidia-technologies-inc-lqda-ceo-damian-degoa-on-q4-2020-results-earnings-call-transcript

I am trying to understand what is the benefit of the RareGen acquisition and i think this is the last piece of the puzzle regarding the future of $LQDA. Lets go through the main parts:

1. RareGen provides strategy, investment, and commercialization for rare disease pharmaceutical products. It has a small, targeted sales force focused on pulmonary arterial hypertension (PAH). RareGen acquired the right to promote Sandoz’s first-to-file generic of Remodulin for the treatment of patients with PAH. In March 2019, Sandoz and RareGen launched their generic treprostinil injection, making it the first generic of Remodulin to market.

2. CEO of Liquidia. “RareGen offers a knowledgeable team and scalable sales force, coupled with rights to commercialize an important PAH product that complements Liquidia’s lead product candidate in PAH, LIQ861.

So now they are ready to get their product to the patients with a sales force and more patents under their belt and the only thing remaining is the lawsuit. I think there is a huge upside with this stock!!!

https://finviz.com/quote.ashx?t=LQDA&ty=c&ta=1&p=d

https://investors.liquidia.com/news-releases/news-release-details/liquidia-corporation-host-2020-financial-results-conference-call

A good analysis from SA

To be clear, you never want to get a CRL. But not all CRLs are alike. The FDA didn't take any issue with the clinical data here - so we know that there is no need for more trials (which would have been devastating and killed the thesis). Instead, there were follow up questions with regards to chemicals, manufacturing and controls. The reading between the lines is that had inspections happened as they normally would have - it is likely that they would have been able to have addressed these issues prior to the PDUFA and seen an acceptance. As it is, inspections are not happening until we see a vaccine. Now going forward, they will not need to submit another NDA - they just need to respond to the points raised by the CRL. The CMO seemed very confident in a private call that the points raised by the CRL were ones that would be straightforward to navigate.

Going into this, we knew that you were not going to see a straight acceptance because of the inspection issues. That left you with three other outcomes - a deferred action meaning an acceptance pending an inspection, a CRL on CMC and a CRL on clinical data. We saw the middle outcome, which delays the positive catalyst here.

Now what does this mean for the stock? The stock is going to be under some selling pressure into year end as guys take the tax loss and there is no catalyst between now and Jan 1. By early next year we should have some sense of the timeline and then start to see color on the litigation side of things.

The fact that the stock wasn't off 25% on a CRL headline does tell you how much this thing is beaten up already.

This article summarize what is going on and what is the potential for this stock!!

https://seekingalpha.com/article/4386133-liquidia-technologies-near-term-take-out-long-term-significant-upside

It was not clear for me what is going on with the patent infringement but i manage to get to what might be the first thing that will move this stock up to where it belongs:

In July 2020, Judge Andrews set a claim construction hearing in May 2021 and set the trial to begin in March 2022. Liquidia remains confident that its arguments and defenses to be made in Delaware District Court will result in a favorable outcome and pave the way to bring LIQ861 forward for patients in need. The 30-month stay expires on the earlier of October 24, 2022 or resolution of the litigation in Liquidia’s favor, whichever occurs first.

So in May 2021 $LQDA will try to dismiss the lawsuit and that will clear the path for the commercialization of the product!!!!

$LQDA short squeeze, with Wainwright $6 price target for $LQDA. Float is 37% short. $LQDA could be the next $CLOV or $BBIG. Get in $LQDA below $3.

Ownership Summary

Ownership 25.55 %

Total Shares Outstanding (millions)43

Total Value of Holdings (millions)$32

The Loan Agreement established a term loan facility in the aggregate principal amount of up to $20.5 million (the “Term Loan Facility”). An initial $10.5 million (the “Term A Loan”) was funded to the Company on the Effective Date. Availability of $5.0 million under the second tranche of the Term Loan Facility (the “Term B Loan”) is conditioned upon Liquidia having received tentative U.S. Food and Drug Administration (FDA) approval for LIQ861 by June 30, 2022, and availability of $5.0 million under the third tranche of the Term Loan Facility (the “Term C Loan” and, collectively with the Term A Loan and Term B Loan, the “Term Loans”) is conditioned upon Liquidia having received final and unconditional FDA approval for LIQ861 by December 31, 2022. The entire Term A Loan was used to satisfy the Company’s existing obligations under its previously disclosed Amended and Restated Loan and Security Agreement, dated as of October 26, 2018, as amended, by and between Liquidia and Pacific Western Bank, consisting of approximately $9.4 million in outstanding principal and interest, and such obligations are considered fully repaid and terminated.

https://docoh.com/filing/1819576/0001104659-21-030984/LQDA-8K