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https://www.huffpost.com/entry/dexamethasone-improves-covid-19-survival_n_5ee8d174c5b6add763186a96
Those two HIV, drugs keep showing up
Lannett selling Adderall IR and XR !!!!!!
$1.75 Billion combined market.
Lol... welcome back sir. We miss your posts. Have a great weekend!
Gee one day up and the next down.....yawn.
Lannett Is Confident After FDA Insulin Glargine Meeting
Longtime generics maker Lannett, of Philadelphia, Pennsylvania, said an FDA meeting this week was positive for its pending insulin glargine biosimilar application.
June 12, 2020
Lannett, a longtime generics manufacturer, emerged with confidence from a June 9, 2020, FDA meeting on the pending Biologics License Application (BLA) for its insulin glargine biosimilar candidate, which would reference the diabetes control product Lantus.
“At the Biosimilar Biological Product Development Type II meeting held earlier this week, the FDA provided positive feedback on the clinical and [chemistry, manufacturing, and controls] advancement of our biosimilar insulin glargine that was consistent with our expectations,” said Tim Crew, CEO of Lannett, in a statement.
A Significant Market
Insulin glargine is a long-acting agent used to manage high blood sugar in adults with type 2 diabetes and adults and pediatric patients with type 1 diabetes. The market for insulin glargine is dominated by large producers and is estimated at $9.5 billion, which makes it an attractive target for Lannett.
“Biosimilar insulin glargine represents a significant opportunity for Lannett, given the notably large addressable market,” Crew said. “Moreover, we believe only a relatively small number of competitors have the technical expertise and requisite resources to develop and manufacture such a complex product.”
Lannett, of Philadelphia, Pennsylvania, intends to file under the 351(k) pathway of the Public Health Service (PHS) Act of the Biologics Price Competition and Innovation Act, which provides for the licensure of biosimilars or interchangeables considered highly similar to FDA-approved originator products.
“Our path forward is clear with regard to what is expected in the planned 351(k) biosimilar application, which we anticipate will be filed in calendar year 2022. We will work with our strategic partner to complete all the necessary development activity, including human clinical trials, in accordance with FDA’s guidance,” Crew said.
As of March 23, certain protein products, including insulin and insulin analogs, human growth hormone, pancreatic enzymes, and reproductive hormones, will be reviewed under the PHS Act, as opposed to the Federal Food, Dug, and Cosmetic Act, the former pathway to approval for these agents.
Regulators hope that the new pathway will remove barriers that have stymied competition in the past and help lower prices for patients, who have faced high out-of-pocket expenses in the past. Many have had to forgo appropriate or regular treatment with insulin because of affordability issues. Recent policy changes, however, have led to caps on insulin out-of-pocket costs that have lessened the burden for patients.
The goal of the FDA meeting was to discuss the design and end point of human studies required for the BLA. The company in December 2019 announced positive results from a pharmacokinetics and pharmacodynamics study of the biosimilar candidate in healthy male adult volunteers.
I see. Thanks sharkey1
No, they do not make that quinine drug but they do make Lopinavir and Ritonavir, which is part of the new study
Does Lannett make hydroxychloroquine? I don’t see it on its website. Can you post the link? TIA
It has nothing to do with Elite.
so today's pps action tells us how poorly lci is selling elite crapola
LCI distributes Elite’s/SunGen products.
They have recently entered A combined market of $1.7 Billion with their 2 new Adderall products.
I know I’m on the LCI board but does this help Elite? Are they involved at all? Thanks
the PPS action of ELITE today tells it all how good Lannette is selling Adderalls. UP UP and AWAY!
Looks like Elite hired 3 more people, Lannetts partner is cooking a long
https://www.elitepharma.com/careers/
June 15th after hours.
It will give a hint how Lannett is doing with both Adderalls.
Lannett’s partner ELTP is having financials in a few weeks.
It will give an idea how Lannett is distributing Adderall IR and XR
https://www.yahoo.com/news/first-drugs-treat-coronavirus-could-172754714.html
This stock should skyrocket
It continues, this article is from Hong Kong, just updated, now we are waiting on Joliet
https://www.contagionlive.com/news/phase-2-trial-antiviral-therapy-recovery-covid-19
Unloaded with minimal gains today.
I think we can get better prices this week.
A NEW HOPE
https://www.nwherald.com/2020/05/11/joliet-hospital-to-use-new-3-drug-treatment-for-covid-19-cant-obtain-remdesivir-at-this-time/ascuacx/
lannet should be getting some orders
6 hours ago, this is a moving target
https://www.healtheuropa.eu/drug-combination-shows-promise-for-treating-covid-19/99874/
I wonder if we will hear from Lannett about these latest studies going on
https://medicalxpress.com/news/2020-05-triple-antiviral-drug-combination-early.html
this could be the ticket
probably the 20% dip is related to the deal with elite. companies that partner with elite always end up badly
Just realized so many folks I know of here.
GL
Doesn't matter, a mallet hammer, a ball ping hammer, a sledge hammer, will still make you scream with excitement..
Not a very big hammer!
It's HammerTime !!!
Lannett To Report Fiscal 2020 Third-Quarter Financial Results, Host Conference Call On Wednesday, May 6 @ 4:30 pm std
PHILADELPHIA, April 29, 2020 /PRNewswire/ -- Lannett Company, Inc. (NYSE: LCI) today announced that it will report financial results for its fiscal 2020 third quarter on Wednesday, May 6, 2020, after the market closes. Lannett management will host a conference call that same afternoon at 4:30 p.m. Eastern Time to review the company's performance and answer questions.
The conference call will be available to interested parties by dialing 800-447-0521 from the U.S. or Canada, or 847-413-3238 from international locations, passcode 49654451. The call will be broadcast via the Internet at www.Lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.
Big Day tomorrow for a Lannett !!!
Enjoy the ride !,,,
LCI
I did cashed in BAC today at $25 though.
It’s a good day for LCI Nas. I believe the Q in couple weeks will look very awesome. I’m not selling yet. Wait for next week when we pass the teens again. Good luck my friend! Go LCI / ELTP!!!!
Thx Sharkey for the link
perhaps. but nothing to do with adderall
nonsense, there is zero data on adderall sales
The SP churning Adderall XR sales will blow this thing north.
1-2 weeks BlowOut Earnings !!
Government is starting to feed LCI business so they don't have to use Chinese API.
Lannett using non-Chinese API
LCI
HammerTime !!!!!!!!1
Any one know Lannett s split ?
Could HEC pharma out of Hong Kong be interested in Lannett, I saw a blurb over on TDA
Didn't make sense.
What is your guess on the revenue? How much do you think we will get from Adderall XR alone for this next Q? TIA!!!
Earnings in a few weeks.
Very Savvy !
HammerTime !
LCI
Hammer time!
LCI has been very good for us this year Nasdaq. It will be even better when we have the next Q in June. I think it will go back to the teens before that. GL on LCI and ELTP as well. Best combo for long term stocks.
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