frisko6@yahoo.com
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Can't wait, We couldn't break 5 mill. in the first 3 months of this year, I thought we could capture 10 % of that 1.3 billion dollar market for XR, granted it's Pandemic, the economy has been booming, the market had been going up the last year, Lannett couldn't sell their way out a wet paper bag.
It's cheaper and faster to have clinical trials in India, smart move by Nasrat.
Another important factor that draws the attention of clinical trials industry towards India is cost competitiveness. The cost for conducting clinical trials in India is one tenth of the cost in the USA. With many pharmaceutical companies relocating or outsourcing the clinical trial processes to India, the research and development expenditure in pharmaceutical industry has witnessed an exponential increase. The timelines set by the regulatory bodies in India ensure the trial applications to be approved in a relatively shorter span of time. For instance, DCGI gives its first response or approval for conducting clinical trials within 45 days whereas for conducting a bioequivalence study it takes 28 working days. Approval of investigational new drug (IND) by any referral bodies or expert would take additional 12 to 14 weeks. Any discrepancies in the applications will be sent back for review and hence delays the process by another 45 days.
If the first trial doesn't work/pass, just tweek the formula and start over.
It cost a lot of money to file an NDA.
The industry, however, “is incentivized to try to get the maximum it can for its user-fee contributions,” he says, and increased safety surveillance that could lead to more product recalls “doesn’t financially benefit them.” At a meeting last summer, an FDA official put it bluntly: “User fees pay for services that directly benefit fee payers,” he said. “This is what distinguishes it from a tax.”
Major pharmaceutical companies generally don’t disclose their user-fee payments. Standard rates for 2021 include roughly $2.9 million for a new prescription-drug application with clinical data and a $336,000 “program fee” levied annually on certain products.
I don't know how much for anda, but I know it's not cheep
they gotta fix this problem
I see in the Orange book, under Elite, Nifedipine has been Discn. finaly the FDA gets around to it, what was that, a year later. lol
Oh, how can they Discn. something they didn't even make, lol lol lol
https://www.accessdata.fda.gov/scripts/cder/ob/search_product.cfm
Calcium channel blockers
To move, all muscles need calcium to flow in and out of the muscle cells. Calcium channel blockers help block calcium from entering the smooth muscle cells of the heart and blood vessels.
This makes the heart beat with less force and helps blood vessels relax. As a result, blood pressure decreases.
Examples of these drugs include:
amlodipine (Norvasc, Lotrel)
diltiazem (Cardizem CD, Cardizem SR, Dilacor XR, Tiazac)
felodipine (Plendil)
isradipine (DynaCirc, DynaCirc CR)
nicardipine (Cardene SR)
nifedipine (Adalat CC, Procardia XL)
nisoldipine (Sular)
verapamil (Calan SR, Covera HS, Isoptin SR, Verelan)
You would think we might some play,
Hope so
https://news.yahoo.com/common-cholesterol-drug-reduces-risk-220249721.html
And now Epic is selling Isradipine for Elite.
TDA says 8/13 Q1, fins, since they are no longer an accelerated filer, it could be right.
In pay to delay, the big boys pay the little generic guys a fee not to make the a drug they want to keep off the market, they both make money.
“Pay-for-delay” is a pharmaceutical industry practice that involves brand-name drugmakers compensating their generic counterparts for holding off on marketing their versions of brand-name drugs, causing longer delays in getting cheaper, generic drugs to the pharmacy counter.
Klobuchar Wants To Stop ‘Pay-For-Delay’ Deals That Keep ...
News from the Capital, they are trying to reduce prescription costs and stop the (pay to delay) this all could help Elite
Fortune
Biden proposes regulations on tech and health care in executive order
Justin Sink
Fri, July 9, 2021, 4:30 PM·3 min read
President Joe Biden will sign a sweeping executive order designed to promote competition across American industries, calling on regulators to increase scrutiny of technology companies, drug prices, shipping and more.
The president’s action will prompt the federal government to set new regulations on everything from airline luggage fees to non-compete clauses, according to a White House fact sheet. He will sign the order later Friday after delivering remarks on the American economy.
The order will direct federal agencies to scrutinize tech companies’ use of consumer data and more closely examine industry mergers, in a nod to concerns that companies like Facebook Inc., Amazon.com Inc., Apple Inc. and Alphabet Inc.’s Google use that data to gain excessive market power.
The order will also ask the Federal Communications Commission to reinstitute net neutrality rules that barred internet providers from blocking or slowing certain content or speeding up delivery for a price. Those rules had been implemented under former President Barack Obama but rolled back under former President Donald Trump.
The tech-heavy Nasdaq 100 futures index was little changed early Friday after fluctuating between gains and losses. Other U.S. index futures advanced.
The president will also call on federal health officials to increase work to drive down prescription drug prices by working with states to come up with plans to import medicines from Canada, where they are cheaper. Trump had also encouraged that idea.
Biden will urge the FTC to stop pharmaceutical manufacturers from paying their generic counterparts to delay entry of lower-price versions of medications into the market. That idea is part of pending legislation in the Senate and aligns with campaign promises Biden made last year.
If only Nasrat could get SequestOx approved, Purdue is divesting, may want to go public, Elite would be a perfect match.
https://www.marketwatch.com/story/15-states-approve-of-oxycontin-maker-purdue-pharmas-plan-to-reorganize-01625757513?siteid=yhoof2
Molnupiravir, new drug for covid in pill form, there are several big players in this trial, lost the link, Phyzer, Dr Ready, Sun pharm to name a few, no Elite though,
https://www.bing.com/search?q=molnupiravir+clinical+trial&FORM=QSRE5
Just doing some DD, about India, looks like a lot of the big players go to India for their clinicals.
https://www.bing.com/search?q=list+of+us+pharmaceutical+companies+in+India+doing+clinical+trials&qs=n&form=QBRE&sp=-1&pq=list+of+us+pharmaceutical+companies+in&sc=0-38&sk=&cvid=0F9BB64D6444469E86E1E820B6BFC3A5
Tried to do a google (elite pharma doing trials in India) no return
per-haps I'm not wording it properly
WOW !!! what a ride, shorts gotta cover, anybody who sold out will be chasing
This is what I dream of, big pharma's buying little Pharmas, now this article dates back to 2019, before the pandemic, but they do name all the big players and what they are looking for.
https://www.investors.com/news/technology/big-pharma-pharmaceutical-companies-mergers/
another company I'm invested in just upgraded their air condition and airflow threw out the facility, and lots of upgrades to the building.
Money is getting cheaper for the big guys and they are always on the lookout to improve their bottom line, almost everybody got hurt do to the pandemic,
jmop
Last year it was Aug 14, this year it should be Friday the 13th, the King will know the exact day, they changed from an accelerated filer
https://elite.irpass.com/Elite-Pharmaceuticals-Inc-Reports-Financial-Results-For-The-First-Quarter-Of-Fiscal-Year-2021-Ended-June-30-2020-And-Provides-Conference-Call-Information-8-14-2020
gonna miss ya Snup, stay close
I was reading the scroll at the bottom of the screen (Wallgreens down 7%) the only thing selling is generic Adderall for sure
Time for this one to come home.
Could be the competition wants to keep this one down, Hey, what's a million bucks to the likes of Teva, one less generic to compete with.
Don't stray to far Snup, one of these days we'LL need you back here,
STAY COOL
THX, looking good
Wow, 3 million shares, somebody wants this thing BAD
Found on yahoo, interesting
https://www.yahoo.com/news/fda-broken-controversial-approval-ineffective-120300323.html
some lite reading for the weekend, food for thought
Johnson & Johnson: Concerta and Risperdal
Johnson & Johnson's Concerta is also a stimulant. Concerta's main patents won't expire until 2017 and 2018, but generic versions have nonetheless been approved. After a court ruled that one of Concerta's patents was invalid in 2009, J&J reached agreements with Watson (now known as Actavis), Impax Laboratories, and other drugmakers to manufacture generic versions of the drug. Those generic versions have taken a bite out of J&J's pharmaceutical revenues.
Last quarter, Concerta sales fell 41% year over year to $150 million, due to competition from generic drugs. In 2013, sales fell 27% to $782 million -- a steep drop from the $1.3 billion in sales that it generated back in 2010.
That decline reduced Concerta from 5.9% of J&J's pharmaceutical revenue in 2010 to just 2.8% in 2013. However, J&J hasn't given up on protecting its remaining Concerta sales with more legal action. In 2013, it sued Osmotica Pharmaceutical's Hungarian Unit over generic Concerta, but later dropped the case. Earlier this month, it sued Mylan for the same reason.
Johnson & Johnson's involvement in the ADHD market doesn't end with Concerta, however. Its antipsychotic drug Risperdal has also been prescribed to children with ADHD in the past. That practice, along with several other controversial uses, led to a $2.2 billion fine for J&J last November for the improper off-label promotion of the drug to children and adults.
Alcobra: A newcomer in nonstimulant ADHD drugs
Last but not least, biotech Alcobra also works in this space. Alcobra's experimental drug Metadoxine Extended Release, or MDX, is a nonstimulant treatment being tested for predominantly inattentive ADHD, which accounts for 40% of all ADHD cases, and Fragile X syndrome, a genetic syndrome that causes autism in boys. MDX was shown to be effective and well tolerated in two phase 2 studies of adults with ADHD. It has begun enrolling patients in a phase 3 trial, with completion expected in the second half of this year.
Certainly, Alcobra is an interesting stock to watch. Nonetheless, this is a small, clinical-stage biotech, so an investment here is comparatively risky.
Foolish final thoughts
The market for ADHD treatments might initially appear saturated with generic drugs, such as cheaper versions of Shire's Adderall and J&J's Concerta.
However, Shire and Alcobra show us that there's still room for improvement in the market. Shire's Vyvanse shows that new formulations of stimulants can be less habit-forming than older ones, while demand for non-stimulants like Intuniv and Strattera remain high. That means there's still room for newcomers like Alcobra to find space in this market with newer nonstimulant treatments.
In conclusion, investors should keep a close eye on these companies and see which of their drugs benefit the most from the sharp rise in ADHD prescriptions over the past few years, especially if that growth continues.
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Darn, you own 900 million shares of this Pharma, you should own the company, and now you want a 100000 to one reverse split, smells fishy to me
Well, as I understood it, it was a 3 way split, plus extra for manufacturing fees, you will have to go the way back machine to see the details
I'm curious too, I mean, we all know you can't up list a 5 cent stock, minimum, 2 bucks, and that's with a lot of street Cred. however they do have every else in order. Cept the share price. Maybe he's talking about a deal with another company, that's my only guess right now.
Just got email from seeking alpha, amended annual report , havent read yet
So let me dig a little deeper.
The revenues would have been even higher, but for a one-time inventory adjustment at our major sales and marketing partner had due to their financial situation.
Legal ees, Is it possible for Nasrat to sell to another distributor, say Prasco, for instance, the inventory that Lannett could not sell, due to the pandemic, there may be an OUT, after all, I would think Lannet wouldn't mind, given the circumstances. or are we trapped?
Of course, they will make it up to the Nasdaq, one of these days they will no longer need retail shares when they make their move.
Well, I'm all for it too, with the upgrades and that 1000 kilo fluid bed dryer, Nasrat said they can pump out up to 750 million pills a year, as long as they can get the API, maybe working 24 7, but it can be done.
my take is most of the plant sits idle, waiting for orders.
too bad Elite can't step up to the plate with a pill for covid
https://www.yahoo.com/news/pill-treat-covid-19-u-121338217.html?.tsrc=fp_deeplink
wheres LePree when we need him
Thanks for the shout out Snup, were all ok back on our ranch.
Thank you Snup, No bailing till November, maybe Nusrat will throw us a bone, this could get hot, as the pandemic eases and we get back to normal
Well, things change, IE pandemic, we will see if he makes a compromise,
we all see the numbers and potential. That generic plant in Jew jersey is state of the art, it's a clean machine.
Just a stumble, not a fall
Lannett would make a good bolt-on for JNJ
Can't wait till Jan. 22, or is it 22 fiscal which is now ?
OK, I'll bite, what are the 8 they are working on
What's up with Glenmark, I thought I heard a whisper years ago that Nasrat turned down their offer of a buyout, they wanted Elite for peanuts, as do others. and now we are back with Epic, I have no clue as to how Epic markets products
We have a new partner for Isradipine and Phentermine, which is actually an old partner, it’s Epic Pharma. These two products, Isradipine and Phentermine are interesting products because they have limited competition. Glenmark our previous partner was not able to give them the attention we believe they deserve. We expect Epic to be more effective in the marketing of these products.