AQST: Libervant FDA Approval (Dec 23rd)? Bullish chart?

I found this reddit thread:
https://www.reddit.com/r/SqueezeTalk/comments/rjzw64/aqst_this_week/?utm_source=share&utm_medium=ios_app&utm_name=iossmf

Here is the bullish chart pattern I’m referring to: (daily) (inverse head and shoulders with bounce off neckline)

MACD, RSI. and Stoch:

This stock is optionable.

Previously the FDA was like “certain weight groups showed a lower drug exposure level than desired.”
So they delayed the FDA approval to Dec 23rd 2021, this week!

ONE STRATEGY IS, MAKE MONEY OFF THE PRE-FDA APPROVAL RUN-UP (IF THERE IS ONE). THEN LEAVE A GAMBLE SIZED POSITION FOR THE ACTUAL EVENT.

WHY AM I SAYING THIS? FBIO got their approval delayed even further, and was about IV Tramadol, which I learned later was actually quite risky.

Notes:

Here is an article by yahoo about some reformative lawsuit regarding the original delay for AQST:

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What is the content of the CRL for Libervant?

  • The FDA cited that, in 5 subjects in two weight groups in our NDA Study 180323, there were lower absorption rates indicated in 2 out of 7 weight categories and that it
  • seeks an increase in exposure in both weight groups before Libervant can be approved.
  • At the overall study level, the FDA acknowledged that Libervant achieved comparable absorption rates (Cmax) when compared to Diastat (diazepam rectal gel)
  • The FDA also noted protocol deviations in Study 180323 in a small number of blood draws in a limited number of patients for timepoints of 3 days or later
  • There were no other safety, clinical pharmacology/biopharmaceutics, CMC or non-clinical issues identified in the CRL.

What is Aquestive’s action plan to address the issues raised by the FDA in the CRL?
The Company intends to provide to the FDA additional information on PK modeling to demonstrate that relatively minor adjustments to dosing in these two weight categories will reach the desired exposure levels.

Highlights from the Q3 2021 Earnings Call related to the upcoming PDUFA of Libervant

  • We continue to have multiple interactions with the FDA as they completed the mid-cycle review of our application in late September.
    They (FDA) did give us language changes on our packaging, both on each individual strip and on the box that it will be – that they’ll come in
  • Libervant would be the first orally delivered diazepam product for the management of seizure clusters.
  • Launch preparations are advancing. And if approved by the FDA, we plan to launch shortly after market access is granted
  • We also anticipate feedback from the FDA regarding our pre-IND meeting data package before the end of December.
  • They’ve (FDA) actually asked us to extend the model to some of the groups that the dosing doesn’t cover. So, we’ve had some questions, but none that would cause us to believe that they’re questioning the model or that the model isn’t the right path to the dosing recommendations that we made.

Couple of thoughts from me:

  • The law action is by now standard if a company receives a CRL, we see it all the time
  • AQST is third to the market but the first oral product which provides significant quality of life benefits for the patient population
  • The clear guidance from the FDA on the language to be used on packaging / SMPC and the discussion on the model seems bullish
  • The question is if AQST was able to demonstrate that adjustments to dosing in these two weight categories will reach the desired exposure levels without additional clinical evidence
  • I guess the company will be informed earlier than 23 Dec by the FDA, but I believe the company has 72hours to inform shareholders
  • The last PDUFA run was 9$ but at this time the small to medium-cap pharma/bio market was not bearish like it is this year and in the last 5 Days it is already up 13%

My bet is it will be approved given the oral treatment but we will see a sell the news action and questions about which labeling it will receive.

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Not a lot of info to be found on this one from what i have found i am approaching this as a approval play with sentiment, the options chain is pretty scarce most of the OI is concentrated on the 7.5c i will be taking a position on this I think the upside is more than good enough to take a few calls for the 7.5 and the 10c see looking for a entry below 5.50 or lower if possible hopefully see a morning dip around 5.10 the options have time in case the approval isn’t on the 23rd barring a denial which would obviously tank all momentum, i like play i think this could see some good green if a good entry is taken especially if a monday dip takes place. Be careful on this one as any fda approval can go bad very quickly.

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I jumped in some 7.50’s I don’t much about it at all so treating it as a lotto

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Read the Reddit DD including the original which is below. This seems very bullish.
https://www.reddit.com/r/SqueezeTalk/comments/rkpysu/aquestive_therapeutics_receives_written_response/

My only gripe is with below study in August.
https://clinicaltrials.gov/ct2/history/NCT03428360?A=10&B=12&C=merged#StudyPageTop


out of 130 trials that started the only 90 completed and 40 not completed.

Any BioPharma people give an opine?

but like @internetkings Im not playing options and took a small shares position for lotto. For now, it feels like sentiment is rising.

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I found this study for intranasal diazepam:

“Of 163 patients in the safety population, 117 (71.8%) completed the study.”

I looked over the safety study for the new drug doesn’t seem bullish lots of side affects, deaths, and inability to take the medicine due to side affects doesn’t attest well to being a better alternative to current rectal treatment. I would like to read up on how the current best treatment faired during clinical trails as well as the article comparing the two but currently not a bullish sign yet from me.

Diazepam safety report

New drug
side affects
Oral irritation related AEs including but not limited to: buccal mucosal swelling, mouth ulceration, injuries to oral cavity (such as tongue or mucosal laceration, broken tooth, bleeding), erythema, stomatitis, gingivitis, xerostomia, staining, dysphagia, dysgeusia, burning, stinging, tingling.

new drug trial saw 30% of applicants withdrawn including 3 deaths and 10 terminated by sponsors with 9 "DOR"s
new drug saw 128 out of 130 applicants have at least one TEAE
new drug saw 43 out of 130 have adverse effects and 30 out of 130 have abuse related adverse effects for a total of 73 out of 130
new drug saw 95 out of 1348 attempts fail because of locked jaw excessive drooling spit out before sticking or other reasons

new drug saw 17 out of 130 have SERIOUS adverse effects (13%)
new drug saw 2.31% mortality rate 3 out of 130 contrast to the annual seizure mortality rate of 0.5 to 100,000 annually (0.00005%)
new drug saw 4 out of 130 having Gastrointestinal disorders (3%)
new drug saw 1 out of 130 developing pneumonia
new drug saw 2 out of 130 cases of Injury, poisoning and procedural complications (1.5%)
new drug saw 1 out of 130 cases of Hypokalemia (0.77%)
new drug saw 1 out of 130 cases of Brain neoplasm malignant (0.77%)
new drug saw 1 case of epilepsy 1 partial seizure and 1 full seizure (concerning since this drug is a seizure treatment)
new drug saw 4 out of 130 cases cause Respiratory, thoracic and mediastinal disorders including 2 respitory failures.

new drug saw 84 out of 130 have MINOR adverse effects (64%)
new drug saw 16 out of 130 cases of Gastrointestinal disorders (12%)
new drug saw 7 out of 130 cases of Pyrexia (5%)
new drug saw 18 out of 130 cases of Infections and infestations (13%)
new drug saw 9 out of 130 cases of Injury, poisoning and procedural complications (6%)
new drug saw 8 out of 130 lead to weight increase/decrease (6%)
new drug saw 44 out of 130 cases of Nervous system disorders including 26 seizures (concerning since this drug is a seizure treatment) (33%)
new drug saw 9 out of 130 cases of Respiratory, thoracic and mediastinal disorders (6%)

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The safety does seem worse than the rectal gel.

A couple things I have noticed so far:

Only one of those 3 deaths was included in the safety analysis set.
The annual seizure mortality rate may not be an apt comparison if it includes the general population.

For some reason: “There were no other safety, clinical pharmacology/biopharmaceutics or CMC issues identified in the CRL.” (according to Bloomberg and GlobeNewswire)

Today’s volume was around 3x it’s average. The price also rose. Sentiment seems to be quite positive regardless of what happens.

It seems that Diazepam is already an fda approved drug and what they are seeking approval on is their buccal film delivery method, so the thing they are trying to prove is that there delivery method is superior to the current method. this trail below shows the comparison between the two I’m seeing 2 out of 15 unable to complete the trail for the buccal film while 16/16 are able to complete the rectal delivery method. I also see 13/30 adverse effects for the buccal film (41.94%) vs 10/29 on the rectal delivery method (34.48%) this looks to be a very small trial size

https://clinicaltrials.gov/ct2/show/results/NCT03953820?term=Diazepam%2Brectal%2Bgel&draw=2&view=results

Below is the trial result for the buccal delivery system does show a 33/33 (100%) Successful insertion. A 29/34 on No-DBF was not Swallowed (85%). A 33/33 on buccal not being blown out (100%), and a 33/33 on saliva not exiting the mouth (100%). Now compare this study to the safety and tolerability study which shows 1324/1348 success on excessive drooling (98%) 1331/1348 success on spitting out the buccal film (98%) 1253/1348 on total success in delivery method (92%)

https://clinicaltrials.gov/ct2/show/NCT03179891?term=Diazepam+buccal+film&draw=2&rank=4

Some thoughts
I’m seeing high success rate on ability to get the medicine delivered on the buccal film.
I can’t seem to find any research on the rectal delivery system to see if they have equal amounts of side effects.
The sample size on the buccal film seems to be really low.
The rectal delivery method seems slightly better on one really small trail but might not be conclusive.
I will sit this one out unless I can find a adverse effect report on the rectal delivery system.

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I found this comparing nasal spray vs rectal gel:
https://clinicaltrials.gov/ct2/show/results/NCT02474407

Thank you for the study, I followed the company and found an article saying how they discarded the project due to not being able to prove the nasal spray being more effective.

This could be good if we can compare the nasal spray to the buccal delivery method results we could get a good indicator on whether or not this will get approved.

also another bullish article it seems like all this needs is to prove it’s as good as the current treatment doesn’t necessarily need to be better.

Mean maximal plasma concentration (Cmax) values for the buccal film were 204.26 ng/mL compared with 211.22 ng/mL in the rectal gel group.

The failed nasal spray only had a Cmax value of 1357.7 (802.78) vs the rectal gel being 2117.9 (996.27)

The Buccal film showed a 41.94% side affect ratio compared to the rectal gels 34.48%

The failed nasal spray showed a 76.92% side affect compared to the rectal gels 25.64%

The buccal film is much closer to the rectal gel in terms of effectiveness and adverse effects then the nasal spray

Still I see that the FDA requested more data with the new NDA application which resulted in the study we saw earlier where we saw concerns about the number of side affects.

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Last bit of research I’m able to find is a study by pfizer on the safety and efficacy on diazepam in general.

https://clinicaltrials.gov/ct2/show/results/NCT00319501?term=diazepam+rectal+gel&draw=2&rank=4

This data shows
For serious adverse effects
2/81 (2.47%) (Double-blind Period)
20/128 (15.63%) Diazepam (Open-label Period)
11/33 (33.33%) Diazepam (Open-label Extension)
3/79 (3.80%)Placebo (Double-blind Period)

For minor adverse effects
33/81 (40.74%) Diazepam (Double-blind Period)
43/128 (33.59%) Diazepam (Open-label Period)
20/33 (60.61%) Diazepam (Open-label Extension)
32/79 (40.51%) Placebo (Double-blind Period)

These show high levels of side effects in the drug itself.

Bull case
Adverse effects in the safety study are attributed to diazepam being an unsafe drug in general.
Shows high levels of being able to be delivered properly.
Shows closeness in effectiveness to rectal gel.
Able to be administered quickly by self.
Stock already has positive sentiment so could always just play the run up.

Bear case
Safety study cause the application to be denied.
Broader market is down currently.

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This is bullish

Just got news that FDA is delaying approval.,

Do we know when the delay may happen now? And I’m guessing this is neither bullish or bearish because this happens a lot?

Already down 25%. Avadel got a delay in October and still does not have a new date. I wouldn’t count on anything soon

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Wow! Down 25% is insane. Didn’t know that was going to happen off of the delays. I remember OCGN was delayed and it didn’t go down like this. Seems unusual to me.

Well I got destroyed.

I think I’m done with FDA approvals…

“The FDA is not requiring any additional information from Aquestive at this time.” That seems good but if Avadel still isn’t scheduled then I would assume this play is done.

Same. First got burned on CRVS, now this. Not touching pharma crap ever again.

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