Lannett Company Inc. (fka LCINQ)

[sharkey1]

https://finance.yahoo.com/news/lannett-receives-fda-approval-manufacture-105300879.html




GOOD NEWS

[sharkey1]

Now pay attention boys and girls

https://finance.yahoo.com/news/1-u-fda-warns-adhd-215548085.html

that means you


lol

[sharkey1]

https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Amphetamine%20Aspartate;%20Amphetamine%20Sulfate;%20Dextroamphetamine%20Saccharate;%20Dextroamphetamine%20Sulfate%20Tablets&st=c&tab=tabs-1

[sharkey1]

I hope so, Nov. should be looking good,

[NASDAQ2020]

If Lannett is running out of Adderall XR it means that they are selling everything Elite can make.

[sharkey1]

https://www.bloomberg.com/news/articles/2022-09-19/adderall-shortages-in-us-spread-to-two-more-drug-suppliers?leadSource=uverify%20wall
Hope they called Nasrat to order more, or maybe it's part of the downturn , or separation from Elite, to start reducing orders to clear out the inventory before next March.

[sharkey1]

I wanted to save this page
https://www.bda.bg/images/stories/documents/bdias/drugs2_list2_1.htm

[sharkey1]

Hey Nasrat, Hakim, can we talk ?, this is in your future, please take us long for the ride,

[sharkey1]

Lets not forget how easy it can be to be led by a crazy person into collective hive mind, society , in an instant of time,
we must be careful

[sharkey1]

My wife was playing some old Harrison tunes and I could not reconize some of the cadence

and you will notice

that's cool, I like that, both songs

[sharkey1]

Looks like Elite got out just in time.
https://finance.yahoo.com/news/news-flash-2-analysts-think-124624362.html

[NASDAQ2020]

The noose is tightening around LCI

May be time to short this one ?

[sharkey1]

file://

[NASDAQ2020]

Products & Pipeline


Drug Market Size Approved Launched Competitors Marketing Partner Notes
Adderall 338 M Yes Yes 11 Lannett 50% owned by Mikah Pharma
Adderall XR 1.5 B Yes Yes 8 Lannett 50% owned by Mikah Pharma
Dantrolene 6.3 M Yes Yes 2 Lannett
Isradipine 5.5 M Yes Yes 1 Epic
Loxapine 5 M Yes Yes 3 Prasco On FDA drug shortage list
Naltrexone 16 M Yes Yes 5 Tagi
Phendimetrazine 4.5 M Yes Yes 4 Elite distributes on their own
Phentermine Capsules 7.5 M Yes Yes 7 Tagi
Phentermine Tablets 40 M Yes Yes 9 Tagi
Trimipramine 2 M Yes Yes 1 Epic
Tylenol with Codeine 45 M Yes No 4 On hold. See latest 10-K.
SunGen Antibiotic #1 85 M No No Unknown Filed. Awaiting FDA approval.
SunGen Antibiotic #2 70 M No No Unknown In negotiations with SunGen
SequestOx Unknown No No Unknown On hold. See latest 10-K.
Undisclosed ANDA #1 Unknown No No Unknown To be filed CY 2022
Undisclosed ANDA #2 Unknown No No Unknown To be filed CY 2022
Undisclosed ANDA #3 Unknown No No Unknown To be filed CY 2022
Undisclosed ANDA #4 Unknown No No Unknown To be filed CY 2022
Undisclosed ANDA #5 Unknown No No Unknown To be filed CY 2023
Undisclosed ANDA #6 Unknown No No Unknown To be filed CY 2023
Undisclosed ANDA #7 Unknown No No Unknown To be filed CY 2023
Undisclosed ANDA #8 Unknown No No Unknown To be filed CY 2023
[/img]

[sharkey1]

I wanted to save this for future reference , so I put it here.

https://contracts.justia.com/companies/elite-pharmaceuticals-inc-1799/contract/194552/

[sharkey1]

Lannett just got their generic Adderall tablets approved , now they have both tabs and caps, IR and XR, lets see how they play it,

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process

[The ELTP King]

Jun 1, 2022

LANNETT PROVIDES UPDATE ON PIVOTAL CLINICAL TRIAL FOR BIOSIMILAR INSULIN GLARGINE

[The ELTP King]

May 12, 2022

LANNETT ENTERS AGREEMENT TO BE EXCLUSIVE U.S. DISTRIBUTOR OF FLUDARABINE PHOSPATE FOR INJECTION, USP

[The ELTP King]

May 4, 2022

LANNETT REPORTS FISCAL 2022 THIRD-QUARTER FINANCIAL RESULTS

[The ELTP King]

Mar 29, 2022

LANNETT INITIATES PIVOTAL CLINICAL TRIAL FOR BIOSIMILAR INSULIN GLARGINE

[NASDAQ2020]

Elite Pharmaceuticals Lannett's Partner Receives FDA Approval For Generic Sabril®

NORTHVALE, NJ / June 29, 2022 / Elite Pharmaceuticals, Inc. ("Elite" or the "Company") (OTCQB:ELTP), a specialty pharmaceutical company developing niche generic products, today announced that it received approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for a generic version of Sabril® (Vigabatrin USP) 500 mg powder for solution packet.

Vigabatrin is an antiepileptic drug indicated for refractory complex partial seizures and used as an adjunctive therapy in patients who have inadequately responded to several alternative treatments. Lannett Company, Inc. has an exclusive license to market and distribute the product in the U.S. and territories. Elite will exclusively manufacture and package the product for sale for an agreed-upon transfer price. The companies will share in product net profits.

[sharkey1]

More dots,
Roivant is getting some pub today, up early pre-, they are working with PFE, and a partner with Dexcel, and so is Elite.
Nasrat asked Pfizer for help with SequestOx, all he got was a blank stare.
https://finance.yahoo.com/m/8e384f1e-379f-3524-a654-3afc246311d2/roivant%2C-pfizer-unveil.html?siteid=yhoof2&yptr=yahoo

[TGOO]

LCI blowing up on stocktwits this morning...

[sharkey1]

Connecting some dots

https://hurun.net/en-US/Info/Detail?num=44YP8JRTLKX2

Now you may ask who is the Raffles family, well they are hugh, scroll down about half way on this page to the Ks and you will see KBP Bio.
Added to the list.
Now you may ask, who is KBP bio

https://kbpbiosciences.com/

Bob Chen was just hired to Elite last month ,comes from KBP, as the new CFO, smart guy, knows a lot about a lot, throw in M&A in his basket.

Look at KBPs pipeline

[TGOO]

up over 23% on FDA approval news...

[sharkey1]

looks like Lannett is being played, up down up down up down

[NASDAQ2020]

their launchin it to $1.00+

[sharkey1]

Sorry bout the pops ups , but this as clean as I can get it,
https://www.bizjournals.com/philadelphia/news/2020/01/13/lannett-secures-milestone-fda-approval-for-branded.html#:~:text=The%20Food%20and%20Drug%20Administration%20on%20Monday%20approved,trials%20to%20secure%20an%20approval%20for%20a%20product.

OK, Numbrino is supposed to be used during surgery,to help numb the pain, works for me, OK,
when the pandemic started ,surgeries stopped,
Now what is Numbrino ,you may as Marve,... a Cocaine nasal spray

need i say any more, lol

[sharkey1]

good to see Lannett picking up, this is real time quote

https://www.cnbc.com/quotes/LCI?qsearchterm=

they have been threw the grinder. Got blasted due to Covid, call me stupid but I would love to try some of that Numbrino, lol ,last I heard they were about 600 mill in debt., now that is beyond me, but they still make about 300 mill a year, so as long as they make their payments it's all good

[sharkey1]

I also ck this site daily, or at least once a week since that stupid war started

https://www.defconlevel.com/

only started cking a couple of months ago, been a 3 for a while,
if it goes to 2 look out, duck and cover, listen for air raid sirens, if it goes to 1, head for the hills, and also, try to get some potassium Iodine, or iodide pills, just in case,

[jammy32]

How do you know these are hires? Maybe they are replacing employees that have quite because their stock has gone down over the past 9 years.

[sharkey1]

Makai, looks like JP Morgan just bought 109k shares, If I'm reading the filing right

https://app.quotemedia.com/data/downloadFiling?webmasterId=101533&ref=116753443&type=HTML&symbol=LCI&companyName=Lannett+Co+Inc&formType=SC+13G%2FA&dateFiled=2022-06-03&CK=57725


could be the reason for the bump,
JP likes the future for Lannett

[Makai63]

Up 23% without news!!

[Makai63]

Up 14% today without news...

[sharkey1]

Elite just hired 4 more people, just one left, Indeed

https://www.indeed.com/cmp/Elite-Pharmaceuticals,-Inc.-1/jobs

[sharkey1]

Good news from the shortage page RESOLVED


https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm

[sharkey1]

Can't believe how difficult it is to get a new drug approved, case in point
Verrica, never herd of them, but they keep trying, 3 times now

https://pink.pharmaintelligence.informa.com/PS120021/Complete-Response-Letters

now ,Elite has several ANDA's in the works haven't herd a peep, SequestOx was rejected several years ago, but they keep trying.

[jour_trader]

That’s also not how vesting works. Not sure why you are posting this on an LCI board. Off topic.

[jour_trader]

That is not how options work. That is not even remotely correct.

[sharkey1]

Mr. Chen is allowed to buy 900k shares at the OTC stock price the day he steps foot on Elite property as a hired employee.
at close on May 16 was .0375

Upon approval by the Board of Directors of Elite, Mr. Chen will be granted stock options to purchase 900,000 ELTP Shares. The options will vest over a three-year period, commencing one year from the date of issuance. The strike price will be equal to the closing price of the Company’s stock as traded on the OTC Bulletin Board (symbol ELTP) on the first day of employment.

[jour_trader]

CFO hasn’t received any shares. Per the 8K:

“Upon approval by the Board of Directors of Elite, Mr. Chen will be granted stock options to purchase 900,000 ELTP Shares. The options will vest over a three-year period, commencing one year from the date of issuance.”

[sharkey1]

Looks like finally the new CFO for Elite got his 900k shares, 500k went threw last week and now 400k, will be looking for that elusive 8K, or from 4 or is it form 3,?, soon'

Looking for his direction, he can't cook the books but he can give advice.
OH, looks like the strike point is .0375, just grueling , took over a week

[sharkey1]

Pfizer is on the prowl, I wonder if they are looking at Lannett

https://seekingalpha.com/article/4513633-pfizer-managements-m-and-a-activity-is-winning-me-over?mailingid=27801867&messageid=must_reads&serial=27801867.2468640&utm_campaign=Must%2BRead%2BMay%2B22%2C%2B2022&utm_content=seeking_alpha&utm_medium=email&utm_source=seeking_alpha&utm_term=must_reads

[jour_trader]

As long as Elite can get the API. Few weeks back there was post that Lannett was out of stock for IR. That’s the moneymaker right now. Hopefully short term issue.

[sharkey1]

The shortage page has been updated again and looks like Lannett is having no problem filling orders,

https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Amphetamine%20Aspartate;%20Amphetamine%20Sulfate;%20Dextroamphetamine%20Saccharate;%20Dextroamphetamine%20Sulfate%20Tablets&st=c&tab=tabs-1

that's a good thing

[AJSails]

Director Patrick Lepore acquired a total of 50,000 shares at an average price of $0.54. To acquire these shares, it cost $27 thousand.

What’s Happening: Lannett entered into an agreement with Areva Pharmaceuticals to be the exclusive the U.S. distributor of fludarabine phosphate for Injection, USP, 50 mg/2mL, single-dose vials.

https://www.benzinga.com/trading-ideas/long-ideas/22/05/27274370/executives-buy-around-9m-of-4-penny-stocks

[sharkey1]

I wouldn't know where to start Makai63, that's huge money, if it was up to me, I would do is double the sales force, burn up some shoe leather, get back in touch with the street.

[sharkey1]

Were expecting a new ANDA for Elite, by June 14, and I don't see any CRL's for Elite on this page

https://pink.pharmaintelligence.informa.com/PS120021/Complete-Response-Letters

so far, looking good

[Makai63]

With $106M in cash...what is the company doing to get back in to compliance before the extended time period expiration date?

[sharkey1]

Wow, that was fast, been waiting,

https://elitepharma.com/management-key-employees/

Good to see Dianne is on top of it,

Next,
the new hires, she must be busy


Now waiting for the form 4

And the next 10Q