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So I'm looking at the FDA approval page :
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process&rptName=1&reportSelectMonth=4&reportSelectYear=2022&nav#navigation
So far only 143 for the month of April, we'll get a few straglers in a couple of days, but that is the lowest month i've ever seen, even with the pandemic, I think the average is 350, tells me they are almost done with that labeling crap, been too long, now may be they can get back to doiing what they do best, Approve NDA's and ANDA's, speed up Elite's submitals , instead of waiting 8 months.
Just a thought.
So tell me Nasd2020, with Elite hiring new people, especially a Quality Control assistant, could it be they are going back to a second shift ?, and of course we we all know what that means'
https://elitepharma.com/careers/
should be a question for Koolaid, but you know your stuff
GOOD NEWS, Elite is hiring again
https://elitepharma.com/careers/
something is cooking, and it's not the books, lol
Also, looks like they hired that Raw Chemist
Thanks nasd2020, didn't know that, good to know. Will try to find a P/R or sec. Going back 2 and a half yr.s
Didn't even think about it. As Gilda would say (it's always something)
https://www.webmd.com/add-adhd/news/20220412/fda-warns-of-websites-selling-adderall-illegally
now that's a problem, must be addressed
Had to hold my breath, the stock didn't tank, No problem ,Marc Bregman quit, gave 2 weeks notice, prolly bored to tears, Elite has two big drugs IR and XR, the numbers came in from Lannett, this QTr, and it's just copy paste, insert new numbers, no challenge , wish him 0nly success he was there for exactly one year, gave it his best, and decided to move along, too easy, it's all good
https://www.otcmarkets.com/filing/conv_pdf?id=15736427&guid=TcewkaseQ9xjdth
Don't want to be a sell out, but why can't Elite make potassium Iodine pill,
Potassium iodide shortage reported amid Russia nuclear threat. Europeans are buying iodine pills and potassium iodide for protection from radiation. The demand is creating a shortage in supply and has not been this high since the Fukushima nuclear disaster
can't find a pill where I live now,
Lets get real with Doxy, there was a shortage, and could be now due to API probs, so much demand, look at the list,
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=D
maybe that's why Nasrat wasn't so enthusiatic about this approval, and didn't want to purse it further, could be the next big thing, but until we see a partner, some one who can take it on, and make a difference. The antibiotic saves lives.
it's like, Who you gonna call,
Hopefully Dexcell
Lannett was added to the drug shortage list on 2-28, I call it a badge of honor, so far they have always delivered, that's a good thing
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
After several up dates, they are still hanging in there.
Their taking Adderall for brain fog
https://www.healthline.com/health/adhd-brain-fog
The article is a little long,
FDA Drug Shortages
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Current and Resolved Drug Shortages and Discontinuations Reported to FDA
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Results for: doxycycline
Doxycycline Capsules (Discontinuation)
Doxycycline Hyclate Powder for Suspension (Discontinuation)
Vibramycin Hyclate (Doxycycline Hyclate) for Suspension (Discontinuation)
Just doing some Sunday research
https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Doxycycline+Hyclate+Injection&st=c&panels=0
now, that's injection, it was in shortage, I wonder if Elite is having API
problems ?
found another page
Results for: doxycycline
Doxycycline Capsules (Discontinuation)
Doxycycline Hyclate Powder for Suspension (Discontinuation)
Vibramycin Hyclate (Doxycycline Hyclate) for Suspension (Discontinuation)
Of course Elites's doing Tabs,... just another question
Doxy went to Praxgen in the Orange book
https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm
Veru out of Miami has got them selves a new pill that works, hope they call Elite
https://www.yahoo.com/finance/news/experimental-covid-drug-successful-shutting-193544401.html
So I see they can't make up their minds who there gonna go with concerning selling DOXY, that is, haven't heard yet, I vote for Dexcel, they are world wide, very aggressive and Doxy is not a C2 , like Adderall, could be in demand all over the planet right now
Thanks Benecotto from yahoo msg. board
benecotto5 days ago
DJB, doxy has been around for 40 years and has about 10 generic manufacturers BUT it was in such short supply in August 2020 that FDA authorized use beyond label expiration dates. It was being used to treat COVID patients in hospitals It was also being stockpiled in 2018 for use against possible anthrax attack. There is a sizeable market, and little Elite does not need a lot to be meaningful on the balance sheet. Will all come down to the distributor.
So I'm looking at the chart over there on level 2, on the OTC, there's like 600K shares on the offer to buy, been there all morning, and we get nothing, a person can't even buy a share at this point, tells me one of two things, the market makers got this stock tight and will not let go, or, there is something in the works, it's like trading has been halted for some reason, a back room deal or some sort of litigation , I just don't get it
https://www.otcmarkets.com/stock/ELTP/quote
Pfizer's on the Prowell buying up small Pharmas
https://finance.yahoo.com/quote/PFE?p=PFE
only the ones making money and have something in the works,
HammerTime!
LCI has some powerhouse partners
Most of the big players have it, or another version, I wonder if they need a generic in Israel,
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=D
Doxy helps, could be why it got approved so quickly, put on fast track.
https://www.cureus.com/articles/37354-clinical-outcomes-of-early-treatment-with-doxycycline-for-89-high-risk-covid-19-patients-in-long-term-care-facilities-in-new-york
https://pubmed.ncbi.nlm.nih.gov/32566483/
WOW, and i thought it was just for (Toe Jam Fungus) lol
WHAT THE !!!
https://pubmed.ncbi.nlm.nih.gov/32873175/
They up date the Orange book around the 2nd Friday of each month
It's not that important at stage of the game, its more like a Library.
its not , ELTP, its Elite, Elite labs is another.
https://search.fda.gov/search?utf8=%E2%9C%93&affiliate=fda1&query=orange+book
go to search orange book
Good to see Doxy added to the product list
https://elitepharma.com/products/
That was fast
https://finance.yahoo.com/news/elite-pharmaceuticals-praxgen-pharmaceuticals-receive-110000552.html
didn't see that coming, of course I saw Prax on the approval list, last week. didn't put 2 a d 2 together, thought Elite had given up on the antibiotic , only 50 to 100 mill a year with many players, not much to see here (move along)
the good news is Elite is viable, they are up and running, and they are making money, a clean machine, you just know they had to be inspected before the approval, lol
all is good
Say it aint so Joe.
https://www.thestreet.com/technology/vertex-has-a-pain-pill-that-may-replace-opioids?puc=yahoo&cm_ven=YAHOO
Just kidding, hope it works,
Mark Cuban is going after big pharma'cys, I looked at the list, didn't see any
generic Adderall , unless it's under an odd name I don't recognize
https://costplusdrugs.com/medications/categories/mental-health/
could be many Lannett makes
Must be why the stock is just taking off.
New tax on the rich ? Hey if your JNJ you might want to spend a few billion on a small pharma before uncle Sam takes it away.
https://edition.cnn.com/2022/03/26/politics/white-house-billionaire-minimum-income-tax/index.html
Any thing can happen in this Pharma world, case in point:
https://finance.yahoo.com/m/a71ae5cd-498c-3c46-9146-6971cec11858/how-pfizer%27s-%246.7-billion.html?source=eptyholnk0000202&utm_source=yahoo-host&utm_medium=feed&utm_campaign=article&yptr=yahoo
and that's why I hang on to my Elite shares,Also it looks like PFE got some in side info on that new drug in trials, not fair to retail, but that's life in the big city.
another thing that bugs me, when you see 250k or 500k on the bid at 3 cent's all day and not a blink, because no body is selling, The market makers gotta be pullen their hairs out
Connecting some dots: Roivant has got something to do with Dexcel, not sure what they do, and Dex. is selling IR tabs made by Elite to Israel
https://dexcel.com/
and now Roiv. just made a big splash
https://finance.yahoo.com/quote/ROIV?p=ROIV
Elite is becoming very popular
GOOD NEWS: Dexcel will sell every generic Adderall tab Elite can make.. Well that is, their share of the API, Elite still has a contract with Lannett
https://www.marianuniversitysabre.com/2022/03/21/crowdfunding-market-is-expected-to-boom-dexcel-pharma-megagen-oral-science/
Your posts are valuable, keep them coming !!!
For 2022, we have two products under review by FDA, both are licensed products co-developed with partners. We expect approval for one during the first half of 2022.
from Seeking, Elite transcript, looks like they filed 2 products, last year, and since it was done by a 2nd or 3rd party Elite didn't have to file 8Ks, now there is 3 month's left in the first half.
there is more:
Currently, Elite is working on number of generic ANDAs. The products include, those that were mentioned before, such as the central nervous system product and co-development antibiotic tablet.
Concerta has been rumored, but not sure, CNS to be named later.
https://finance.yahoo.com/news/35-generic-drugmakers-sign-manufacture-181936788.html
I hope Lannett and Elite are on that list.
doing a quick search, there was a severe drug shortage at one time, but not now, that I can see.
Looks like Elite hired two more people, may be they will open up another 2nd shift. ?
Interesting, Chartwell does government contracts, and I'm sure they know who Elite is.
Chartwell is on pace to make 22mill. This year with 75 employees, Elite should make 40 mill with 43 employees with just 2 main products.
https://www.dnb.com/business-directory/company-profiles.chartwell_pharmaceuticals_llc.d443ae4b15ab5168b4a989921d4312dd.html
Carmel was sold for 10 million bucks, 9 mill up front, , looks like Chartwell in the new 8 k
Looks like Elite had a labeling problem, just cleared up, but they wern't the only ones, they all had the same prob. Tabs only, caps may be next.
Followed by bankruptcy.
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