AQST Aquestive Therapeutics Inc

$AQST With PDUFA update, this will go up 6+ in no time. Algos just need clarity for movement. That BULL FLAG is so evident. 15%+ day coming soon

$AQST Modeling the scenario where Anaphyl gets FDA approval, transitions to OTC and has a strong commercial adoption (Libervant and 108 not included) (ChatGPT): Potential AQST share prices for successful OTC conversion ($38-40), strong OTC ($69-72), exceptional growth ($92-96, but $2B growth considering world-wide is $115+). As we already know, the global epinephrine market is expected to reach $5.5 to $6.1B by 2030-2034. Also, The company's current presentation identifies, not including present licensing agrrements: • Anaphylm: >$1B potential annual revenue • Libervant: >$100M • AQST-108: >$500M potential annual revenue

$AQST AQST short interest increased an additional 1.7M shares to a total of 27.2M shares thru Sep 15th. It's the highest I have ever seen it, and 3M higher than when it peaked last Dec 31st at 24.1M just before the deficiencies notification. I’m not sure why short interest continues to climb this time, as it seems to be in a much better position to gain approval from the FDA, but anything is possible. I would love to see a short interest squeeze and for the shorts to get burned badly. Please make it happen AQST / FDA.

$AQST - Thank you for highlighting the ongoing shortage of epinephrine auto-injectors. Given these supply constraints, this could be the ideal window for the FDA to grant Anaphylm a Class 1 resubmission designation to expedite its review and bring an alternative to market. What are your thoughts on the likelihood of this happening?

$AQST Before joining AQST, Matthew Greenhawt was the Chief Medical Office for the nation’s oldest and largest asthma and allergy advocacy organization (AAFA). Before that, Dr. Greenhawt, who is Board certified in both Pediatric and Allergy/Immunology, served as a professor at Children’s Hospital Colorado. Dr. Greenhawt’s work with AAFA included development of food allergy and anaphylaxis action plans, decision aids for food allergy treatment, advocacy on precautionary allergen labeling, and patient-centered research on air travel and healthcare access.

$AQST Right now, I'm not even thinking about Anaphylm. Thats on automatic. I want to see the Libervant US partnership come to life before the January launch. That will be their 5th product on the market and the largest, as Suboxone continues to wind down. Suboxone — Indivior, U.S. and other markets Sympazan — Cosette in the U.S. Ondif — Hypera in Brazil Emylif — Zambon in Europe Libervant (coming January 11, 2027) The upfront payment (I'm guessing between $30M-$40M) will be huge and then the revenues from manufacturing it will be huge. The royalties will be single digit, but AQST's bread and butter on these deals is the manufacturing part of it all. People, erroneously, keep looking at AQST as a 1 trick pony with Anaphylm. I pity them.

$AQST it’s time to terminate this worthless partnership with Pharmanovia who has done absolutely nothing with their Aquestive partnership since, 2022 and amended in 2023 to seek approval for Libervant 1. The 3-Year Regulatory "Cushion" According to SEC filings detailing the amended Aquestive-Pharmanovia License and Supply Agreement, Pharmanovia was granted a long runway to submit its first health authority filing. The contract dictates that either party can terminate the deal with three months' notice only if Pharmanovia fails to file for its first Regulatory Approval within three years of the amendment's effective date. Given that this amendment was executed in March 2023, the clause effectively protected Pharmanovia from immediate pressure to file until March 2026.

$AQST Base case is a class 2 resubmission with a target of approval mid Jan. Any earlier is just bonus. Chances of approval are high, and I like the team in place to launch. Libervant is the big x factor. I know management has indicated they are looking for a commercial partner. I have no insight into the progress on this initiative. Probability they are successful? No idea. Just because management said it does not mean it gets done. If they are unable to bring in a partner, what kind of resources would they put towards its launch? We have a large short position that will continue schenanigans until they decide to go elsewhere. The shorts were in control of iova for a long time. Even positive PR's resulted in a declining stock price. This continued until they lost control and are started moving out. As a result, the stock price has exploded. AQST feels like a coiled spring that has forces keeping it at bay. Libervant may be the key in the near term. We shall see.

$AQST I enjoyed the presentation today. The company outlook is strong moving forward. Will be interesting to see how the SP plays in a tough month. But I expect the cloudy skies will pass sooner than later and the line-up of catalysts they have coming make this is a sound Long investment. $7 and then $10 over the next 6 months is very easy to digest. GL to Longs and Bulls.

$AQST The market already expects a class 2 designation. What makes the shorts so confident to increase their position? Could their plans include the following to shake out retail investors? 1. Control narrative that class 2 is a “major disappointment” 2. Coordinate "Short Raids" to Trigger Stop-Losses 3. Create new narrative that Anaphylm will take years to penetrate the market As a long term shareholder, I will hold on tightly to my shares, expecting 2027 to be a great year.

$AQST Thank You Captain Obvious. Do you have any brilliant revelations for us this morning?? Like maybe the sun will rise in the east??? Idiot

$AQST All the boxes are checked for a automatic class 2 determination. Anything that needs substantial review such as new clinical data, new PK, new HF validation. AQST had to do a HF validation study and a new confirmatory PK/PD study. Thats stamped as an automatic class 2. AQST can argue all they want. All the FDA cares about are what boxes are checked. The FDA is a government entity and therefore is robotic. Context is irrelevant. How elementary and easy the HF and PK/PD studies were, the FDA simply says 'our rules say Class 2, so it's Class 2. Especially when dealing with an emergency, life or death product. Given how retarded the FDA was on requiring the PK study attached to the packaging changes, even though it was unwarranted, means they are treating this like a bunch of nervous nellies. That itself screams 6 month review. Now, that doesn't mean it can't be approved earlier than 6 months. It's just very low odds. I'd say 5% chance for Class 1, two month review.

$AQST The market should factor in Sherry Korczynski as AQST's Chief Commercial Officer. The person running the commercialization of Anaphylm, once approved. Epi-Pen became a billion dollar product because Sherry ran Mylan's machine, giving them category control, school/stocking mandates, a device standard of care, and years of pricing power for the Epi-Pen. That is relevant for how Anaphylm gets into allergist offices, pharmacies, and training protocols. With Sherry, there are higher odds they don’t fumble the first 12 months of targeting. Better shot at getting on protocols and talking to the same writers who already know epinephrine. She'll still face the bureaucratic red tape of CVS/payor math, ins uptake time restrictions, real world data support, copay support, and promotions, etc, etc. But at least that will be a smoother process with her running the show. AQST won't suffer from the incompetence that stalled SPRY and shifted them into a 'prove it' play.

$AQST just as I expected this week NDA submission. Let see if we can rally back up with strong volume. I don't see too many down days baring geo political events. Finally our time has arrived 2 months 4 months or 6.months. GL fellow longs

$AQST I own a nice position here. But since the CRL I just put it on a back burner while paying more attention on my other, more in the news, biotechs. But looking this morning a bit closer, I'm realizing how cheap this stock really is. The Market Cap (MC) is just a bit over $600MM. It would be an easy BO in the $2B range. With a product that could disrupt the current market for the treatment of Type I allergic reactions, including anaphylaxis, they should demand much more. For me, $2B would be a joke. I hope the price appreciates to the point were we could get something closer to $5B.

$AQST However the bears want to spin their thesis the fact is Anaphylm will become the go to treatment for anaphylaxis. And scaling will be no problem as they own all their manufacturing. There is absolutely no drawback to buying at these prices, money in the bank.

$AQST w/in the next two weeks we should hear on AQST resubmission and whether Class 1 or 2. Expecting SPRY's playbook, meaning Class 2 but early decision. AQST's CRL was lot simpler.

$AQST Additional of new board member seems to be a signal that the company is going to go it alone post approval. Otherwise, why add him? Either way, it’s a winner.

$AQST SPRY has done us no favors short-term with their collosal commercialization failure. Totally different products and totally different management like night (SPRY) and day (AQST). Long-term this shines!

Four days and counting … Thursday, October 1st, is 14 days from when $AQST re-submitted the Anaphylm NDA to the FDA. The FDA should provide a formal Re-submission Acknowledgement Letter to AQST which would include the Classification (Class 1 which would mean a 2-month review vs. Class 2 which would mean a 6-month review) and the new PDUFA date. It’ll more than likely be a Class 2 re-submission, but I anticipate an accelerated review with approval sometime in January, 2027. Look for a press release and an 8-K from AQST this Friday, October 2nd.