watching biotechs, gold & silver
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Jess, thanks for the reminder
I now have the time to check it out so I will.
Am I correct in thinking you're saying that when Ji claimed SRNE could 'cure COVID' it was due to his unfamiliarity with English? So that, while it appeared he was making a false claim, it was rather that he was using the English word 'cure' incorrectly?
If that is the case, it does put a really different light on my view.
TIA
I think what we have here are all pseudonym.
I wanted to reply that I'm using my real name but couldn't without laughing.
You're certainly correct, BTW
I’m taking a liking to IRWD .....
That's also on my shortlist to check out (I've forgotten why at the moment).
So after your DD, please advise if you buy into it and thanks.
Do any of us know Luna's real name?
'John Galt' is from Ayn Rand's book:
Atlas Shrugged, the book first published in 1957, portrays a dystopian U.S. where soaring taxation, stifling governmental regulations and demonization of success are the norm. Eventually, the most productive members of society begin to voluntarily disappear in an attempt at a bizarre “strike” that is seemingly orchestrated by a mysterious figure known as John Galt.
Jess, thanks for your post to Luna. Thanks for asking him to check in with comments & ideas from time to time. His knowledge and insights are gold, as we all know.
I'm curious how long you and BR will be bosum buddies. Looking forward to your mutual exchanges :)
Maybe it will be like this:
Congrats to all! Our 'buddy' even likes it:
Adam Feuerstein
@adamfeuerstein
·5h
$AUPH Lupkynis label looks good. Inclusion of proprietary dosing instructions should ease concerns about strength of the 036 patent, extending protection to 2037.
Jess, GSK and AUPH differ somewhat on CRR definition:
Pages 90 and 91 state:
Definitions in BLISS-LN trial: Complete Renal Response (CRR): ratio of urinary protein to creatinine of <0.5, eGFR no worse than 10% below pre-flare value or ≥90 ml/min/1.73 m2with no use of rescue therapy.
Definitions in AURORA trial: Complete Renal Response (CRR): Decrease in UPCR to ≤0.5mg in 2 consecutive, first morning void urine specimens, eGFR >60ml/min per 1.73 m2 or no decrease of ≥20% of baseline eGFR on 2
consecutive occasions, No use of rescue therapy and presence of sustained low-dose steroids
Not aware (yet) exactly what differentiates 'CR' from 'CRR', or if they're interchangeable or what.
complete response vs. complete renal response
Hi Jess,
I plead/confess ignorance- I'm not aware of the difference.
Trying to wade through the document.
Any insight, please advise and thanks
Good luck to us today
ICER just released Benlysta-Voclosporin report
132 pages- nice light reading to start the day
Belimumab and Voclosporin for
Lupus Nephritis: Effectiveness and Value
https://icer.org/wp-content/uploads/2020/11/ICER_Lupus-Nephritis_Draft-Evidence-Report_012221.pdf
Who is ICER you may ask?
ICER seeks to provide an independent source of evidence review—free from financial conflicts of interest—to help patients today and in the future by catalyzing a movement toward fair pricing, fair access, and future innovation across the entire US health care system.
https://icer.org/?gclid=Cj0KCQiAjKqABhDLARIsABbJrGnce1NfmM96F-jbOS9wXgyo9Pb93YXzLSTIP3RcT2G4Vgg1p8BIKnUaAnQPEALw_wcB
Excellent summary- from 'Biospace' 3 days ago
Aurinia Pharmaceutical’s Voclosporin for Lupus Nephritis
Aurinia Pharmaceuticals, based in Victoria, British Columbia and Rockville, Maryland, has a target action date of January 22 for its voclosporin. The drug is being developed for several indications, but the NDA is for lupus nephritis (LN), a serious inflammation of the kidneys the result of systemic lupus erythematosus (SLE).
“People living with LN are in need of an advanced therapy that quickly drives the disease into remission and mediates kidney damage,” said Peter Greenleaf, president and chief executive officer of Aurinia, in July 2020 when the FDA accepted the NDA to review. “We will continue to collaborate with the FDA during their review process and in parallel build our commercial readiness for a potential approval and commercial launch in the first quarter of 2021.”
The FDA granted the NDA Priority Review, which expedited the review from the typical 10 months to six months. The NDA was supported by results from two pivotal trials, Phase III AURORA and Phase II AURA-LV.
Voclosporin is a novel and potentially best-in-class calcineurin inhibitor (CNI). It acts as an immunosuppressant, with a synergistic and dual mechanisim of action. By inhibiting calcineurin, the drug blocks IL-2 expression and T-cell mediated immune responses. As a result, it stabilizes the podocyte in the kidney.
On December 17, 2020, Aurinia inked a collaboration and license deal with Japan’s Otsuka Pharmaceutical Co. to develop and commercialize oral voclosporin for LN in the European Union, Japan, as well as the UK, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein and Ukraine.
Only two days earlier, on December 15, Aurinia expanded an exclusive manufacturing relationship with Switzerland’s Lonza to build a dedicated manufacturing capacity within Lonza’s existing small molecule API facility in Visp, Switzerland. The factory will be set up to manufacture voclosporin, while expanding existing capacity and providing supply security for future commercial demand.
https://www.biospace.com/article/fda-action-alert-merck-aurinia-and-amgen/
Love this post from the ST board:
1/19/21, 10:47 PM
$AUPH
Benlysta anyone?
The most common side effects of BENLYSTA include nausea, diarrhea, fever, stuffy or runny nose and sore throat, persistent cough, trouble sleeping, leg or arm pain, depression, headache, and pain, redness, itching, or swelling at the site of injection
BENLYSTA (belimumab) - Increased Risk of Serious Depression, Suicidal Ideation or Behaviour, or Self-Injury
northern, Thanks for checking: .....I think you will agree that he is ( and was) worth every penny of the options/warrants.....
You're not kidding on that score! The good Doctor is a true visionary; he is the one primarily responsible for making Aurinia come to life.
He's remarkable/outstanding in that he's successfully dedicated a good part of his life in efforts to improve the lives of Lupus sufferers. The whole history of Aspreva and how he put the nucleus of the Cellcept team back together for Aurinia is truly impressive/inspiring work.
Wish there were more like him but I thank God for the ones we do have.
He's the kind of guy that it would be great to have a couple of beers with and kick stuff around a bit.
cheers
Actual, thanks. Hope they rocket!
Good luck with them!
WELCOME BACK MY FRIENDS - TO THE SHOW THAT... NEVER ENDS
You could be right. Many or most seem to be looking for an exit Friday or shortly after.
This show could easily continue beyond that.
"What a long strange trip it's been"
Unlike the song, we may not have 'our chips cashed in' for awhile
cheers
PS. I like the fact that when 'Karn Evil 9' was released you had to flip the album over to finish the song, due to the 29-minute length.
We did better with the Canadians. They really are super nice.
Actual, curious what did the Feb $15 calls cost you?
TIA
Jess, I missed it- too focused on AUPH angst to investigate
Saw the jump and HCW $30 target
Thanks again for the tip
I think Dr. Glickman not only has all his shares/options, but also is either running the show behind the scenes, or at minimum is involved in every major decision.
It makes sense that he walked away from all the day to day stuff, and equal sense that he's not abandoning 'his baby'.
We may never know unless there's a post mortem, public story after the BO.
Awesome Anthem!
Now up 8% @ $14.38 (USD)
Thank you Canada
Canadian Stock Market is open today
AUP (AUPH) up 68 cents (USD)
cheers
Thinks Auph takes this one
Hi Luna,
I'm guessing the vote stands at 271 to zero at 8:23 p.m. EST
Surprised by AF's bogus article. Thought he was just a jerk at times; didn't realize he's a jerk with fraudulent tendencies.
Maybe that's unfair and he just has Covid dementia or some other cognitive ailment.
However it's sliced, him blocking you is hilarious!
cheers
The Adam F article re Aurinia, timed for AUPH's biggest OpEx was likely not a coincidence, as Lunacy noted on another board.
Finally saw excerpts from the article this a.m. and can see how it could be taken as pretty negative.
AF raised doubts about the IP2037 patent validity, the ability of Aurinia to market VCS against the size and prowess of GSK, without ever mentioning that Benlysta is a crappy, virtually worthless drug compared to Voclosporin.
Also, AF cast doubt on the Otsuka deal, questioned VCS side effects, cast CNI's in a negative light, and intimated that VCS was similar, etc.
Pretty sloppy and misleading article to those following Aurinia's story.
That semi-hit piece had to be responsible for yesterday's carnage, imo.
At least he stated FDA approval was expected.
Shortly after the article appeared AF posted to twitter that he was gone for a week or so. So is he off on vacation to the Swiss Alps or Caymans with bags of cash to deposit?
Does anyone here have a subscription to STAT?
There's an article today by Adam Feuerstein re Aurina- it's said to be quite positive. Here's the teaser to it:
Aurinia’s kidney drug on the cusp of FDA approval
Next week, the Food and Drug Administration is expected to approve a new medicine from Aurinia Pharmaceuticals that will be used to treat patients with lupus nephritis, a serious autoimmune kidney disease.
If the FDA clearance goes through, the oral drug called voclosporin will be the first commercial product developed successfully by Aurinia, a drugmaker founded in 1993 and based near Vancouver, Canada. Voclosorin has the potential to deliver $1 billion or more in annual sales, but Aurinia has never launched a drug before, and it must do so during a Covid pandemic and with Big Pharma competition.
“We’re in a show-me phase right now, we know that, but we look forward to doing it,” said Aurinia CEO Peter Greenleaf, in an interview with STAT’s Adam Feuerstein.
I do not subscribe but wonder what the rest of the article stated.
TIA if anyone can provide details.
GLTA
Jess, thanks for the info re SRNE
Will check it out
I think Lunacy is just on iHub sabbatical as he's got a lot of stuff in play currently
I'm sure he's still very high on AUPH
Hard to belive we're at this level- must be options related
Outstanding article re Aurinia history (written pre-P3)
https://www.qgdigitalpublishing.com/publication/?i=508946&article_id=3127999&view=articleBrowser&ver=html5
Clearly demonstrates why this is such a high-quality company with such exceptional leadership
Jess, query re SRNE:
I haven't followed them due to the following situation:
On May 15, 2020, during pre-market hours, news sources reported that Sorrento had announced the discovery of the STI-1499 antibody, which the Company described as providing “100% inhibition” of COVID-19. That same day, Defendant Henry Ji, Ph.D. (“Ji”), founder and Chief Executive Officer (“CEO”) of Sorrento referred to Sorrento’s breakthrough as a “cure.”
Since the above wasn't true, I just assumed Ji is a hype machine, BS artist. Since you're currently very high on their prospects, I'm wondering how you see their credibility regarding the science. etc.
Your opinion/input appreciated
TIA
If you didn't catch yesterday's ZOOM call w/Peter,Neil & Ed
Well worth a listen
GLTA
https://journey.ct.events/view/e1dbf931-628c-48b8-932f-cddd8df73d50
Somebody finally pushed the go button.
Cantor reiterated their $27 PT today.
I guess it leaked yesterday- what a surprise to see front running
..... meant who else on this board was on the call.....
Assuming you also saw the 6 a.m. webcast with Peter, Neil, and Ed Arce from HCW.
My take was that Peter has never sounded as positive on the IP2037 label as he did yesterday.
Wonder what others' take on that call was?
TIA for any feedback
.....who else was on it?
Mike Meyers, HCW
Dr. Scott Gottlieb
Arthur Tzianabos
Kent Thoelke
James Breitmeyer
Dr. Frank Torti
Neil Solomons
Thomas J. Schall
Douglas M. Fambrough
Andy Plump
Robert Lannone
Fascinating discussion of COVID impact on clinical trials
Over an hour but very interesting/informative
I believe we”ll hear an endorsement by Gottlieb referring to FDA approval.
I don't see how that is possible. Gottlieb is famous for his integrity. He always recuses himself where there is even a whiff of conflict of interest.
Here there is a major conflict of interest.
I am confident that Gottlieb, who always was a proponent of on-time evaluations and fast-tracks, where warranted, is familiar with AUPH and its test results.
It would be very surprising if he's not. He's part of the team at NEA Managment, which includes AUPH among it's 54 largest positions with over 5M shares.
He also worked for GSK at one time so he's probably more than familiar with LN.
https://fintel.io/so/us/auph
Anti-Viral Effects of Voclosporin in COVID-19 Positive Kidney Transplant Recipients (VOCOVID)
https://clinicaltrials.gov/ct2/show/NCT04701528
Have you ever tried to drive only using a rear view mirror? Not really a smart move.
That's what Kaden Berrington is doing in that article.
Kaden wrote it yesterday so he was probably depressed by what was happening in D.C.
Is this of any concern?
Nope. Do you really take that rubbish seriously?
they are setting it up to be their personal cash cow
The gazillion of options they created for insiders just a few days ago proves that.
Not really. It's more likely it means they know they're about to cash in bigtime.
Why in the world would FDA not approve VOC?
I can think of 2 reasons:
A. Corruption- not unknown at the FDA. Bribes from GSK? Why not? Very possible at Iljin, which means 'gangsters' in Korean. Virtually zero possibility at AUPH.
B. Incompetence- The FDA is a gov't entity. Bureaucrats too frequently make surprisingly bad judgments. I can picture some fool saying "They already have Benlysta, why do they need another LN drug?"
Both reasons seem very far fetched. In an honest and competent world, VCS is a lock.
cheers
the market is definately not acting like fda approval is coming
Yeah, but what the h. does the market know?
I think you're both right. The market might be saying that the FDA might extend the PDUFA beyond Jan 22 due to Covid attention.
If it happens, it could be the last great opportunity to buy this.
It is definitely a mystery.
From Parkinson's to peanut allergy, pandemic puts brakes on new drugs
https://www.mdlinx.com/news/from-parkinsons-to-peanut-allergy-pandemic-puts-brakes-on-new-drugs/2VVS0L9HJZnqN4jYvl2ls6
it sure is perplexing watching this stock underperform so close to PDUFA date!
I'm beyond perplexed. When you strip out the cash the price is $10. It reached a higher price after the Phase II trial results!
Mind boggling to me.
Hallelujah anyway!
cheers
PS. I still say it's highly likely that several years ago there was an evening or two involving the Iljin and Aurinia folks and something went haywire. Maybe someone didn't take their shoes off at Iljin's Chairman's house, maybe another scenario but likely whatever happened involved way too much Soju.
All I know is that Iljin wants to punish AUPH and we're just along for the very bumpy ride on the roller coaster.
All in a world gone mad.
I don't care what the calendar says- 2021 seems a whole lot like 2020 so far.
Thanks Rocky
IRS says "trade (sell)" date, NOT "settlement" date
That makes the action almost sensible
Also thanks for citing the relevant IRS publication
cheers