watching biotechs, gold & silver
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think how the poor pig feels
With such a poor track record, one would normally expect at least the occasional mea culpa.
Earlier you said "We are in good shape but we definitely will hear whining and moaning from some retail investors who watch the pps on a daily basis."
In the world of commerce when there is a substantial sale on something it will bring out the bargain hunters in droves. I think only in the perverse world of Wall Street does the opposite often happen; instead many forego the gift of low price and wait until the price is higher to rush in.
This looks like another classic play that benefits the hedges and the long term holders.
Should be a very interesting year or two while this situation develops.
Not sure you understand how to use them- Did you buy puts at $10?
If you did, you did good. If you buy them now, the odds are you will do bad.
The severe sell off has already happened. Your strategy made sense at $10 but makes no sense at $6.
Time will tell, but the odds are heavily weighted in my favor and are against you.
We shall see who is correct.
Selling covered calls is also a bad strategy if you are bullish on AUPH since in the event of an early buy out you lose your shares.
What you're really saying is that you are bearish on AUPH.
"BUY more PUTS." seems like terrible advice
If you are long and want to buy cheaper, you should SELL PUTS and pocket the $$$ if AUPH rises.
Worst case is you wind up with more shares cheaper, which is a good thing if you believe in AUPH.
So you're surprised but not curious? I'm surprised. What was the point of your post then?
You left out Ray Dalio
OK, I'll bite. Do us a favor and ask them why not and come back and tell us what they say.
Thx in advance
I can't add anything new.....I'm just referencing what we already know that has been posted here.
Lunacy's recent post is a powerful testament:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133929107
I'm in repetition mode here, but the short list of AUPH's advantages are:
Stellar management team, great science, Aspreva success, stellar VOC P2 results, expertise in trial design, FDA Fast Track status, etc.
I simply believe that when you add it all up, it significantly boosts their odds of success in P3.
The claimed 30% chance of P3 success is bogus (MF article)
".....the likelihood that a Phase 3 study would advance to product registration was 64 percent...."
https://www.statnews.com/pharmalot/2016/06/13/clinical-trials-drug-development/
Another source who says 64%:
http://www.fdareview.org/03_drug_development.php
Another source that says 62% (Page 11, under Autoimmune)
https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf
The MF article says, "According to the FDA, around 30% of drugs that make it to late-stage studies win approval."
If the FDA can't even get that right, how many other things are they screwing up?
Assuming the 62-64% numbers are correct, VOC's odds should be in the 75-85+% probability range due to AUPH's really strong position/advantages.
"....there are no degrees to integrity, (high/low), you either have it or you don't..."
Good point- well said.
Integrity is one of the components AUPH has that make it possible to have a high level of trust they will be successful with VOC- some others being great science, they're well funded, and they have a superb track record.
Bottom line is that their combined excellent science and excellent management adds up to an excellent opportunity.
The only serious question I really have (unanswerable) is: Did the population of the VOC arm of the P2 accurately represent the general population of LN sufferers?
".....highly speculative stock as per the ceo....."
You're misquoting Dr. Glickman- watch the interview again carefully.
BTW, high integrity is something to be applauded and not scorned.
"FDA under fire over accelerated approval data demands"
http://www.fiercebiotech.com/biotech/fda-under-fire-over-accelerated-approval-data-demands?utm_medium=nl&utm_source=internal&mrkid=51876159&mkt_tok=eyJpIjoiWTJJeU5HRmpPREl4TWpNMyIsInQiOiJ5UnVpVkpzeVNlZmxTcFE4UytNa0k3aEpwQVluNXFaelhDNnlWdUZCaUM1a0N2dTRMcFBuSzNHc3Y3WXJod3VKQVpXMzJQdW9ZdHFRMXVYTDVnUmdrWWozbXlkZlFENnpBcUNCT2pHNG9MN2E1ZjFBUUYyNlAxbGFjdWpUUk1QMyJ9
I second rumrunner's Happy National Rum Day
It's 5 o'clock somewhere- Dark 'N Stormy time
cheers
cervelo- Don't trash Dr. Glickman- listen to grandma instead:
"I don't set stop loss. I don't buy on margin. I don't sell. I add more when it pulls back..... AUPH has very bright future. Patience is the key."
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=133690526
Don't get suckered by FUD (fear/uncertainty/doubt).
This too shall pass
Senate approves 'right-to-try' drug bill
Doesn't apply to us, but a positive development re FDA reform. Another one of the early signs of the new spirit within the FDA.
"The Senate approved a bill Thursday that would allow seriously ill patients in all 50 states to request access to experimental medicines without Food and Drug Administration approval."
http://www.politico.com/story/2017/08/03/senate-right-to-try-drug-bill-241293
FDA Definition: "life threatening or severely debilitating disease"
Sec. 312.81 Scope.
This section applies to new drug and biological products that are being studied for their safety and effectiveness in treating life-threatening or severely-debilitating diseases.
(a) For purposes of this section, the term "life-threatening" means:
(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and
(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival.
(b) For purposes of this section, the term "severely debilitating" means diseases or conditions that cause major irreversible morbidity.
(c) Sponsors are encouraged to consult with FDA on the applicability of these procedures to specific products.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312&showFR=1&subpartNode=21:5.0.1.1.3.5
"...is LN not considered a life threatening or severely debilitating disease?"
I would like to know what the FDA definition is because everything points to the fact that it is.
Something doesn't seem to add up.
The trial is already complete- stellar results released months ago.
FDA regs say P3 not required for fast tracked drugs.
"Then, in 1988, FDA formalized what is known as the “fast track” designation, which permitted approval of drugs treating life-threatening or severely debilitating diseases after a single Phase II study."
The question is why LN is not considered "life-threatening or severely debilitating"?
Related question is: with a new FDA head, will the Lupus groups/alliances/advocates ask for an early preemptive approval?
Fast Track drugs can be approved after a single Phase 2.
"Then, in 1988, FDA formalized what is known as the “fast track” designation, which permitted approval of drugs treating life-threatening or severely debilitating diseases after a single Phase II study."
http://www.raps.org/Regulatory-Focus/News/2015/09/24/23264/Studies-Raise-New-Concerns-over-FDAs-Expedited-Approval-Designations-Supplemental-Indications/
So why doesn't VOC qualify for approval now???
Isn't LN "severely debilitating"?
" I would think its safe to assume we won't have anybody taking an early look..."
What about the Fast Track status of the trial? Wondering if there is a possible early look benefit?
".... hoping for big changes under Dr.Gottlieb!
Who knows, maybe some conditional approval may be possible, ...."
Good point- what are they waiting for? Why not approve treatment today and do a Phase 4 instead? VOC has been thoroughly tested by more than 2000 people and shown to be very safe, it's shown to be effective as well so the downside is either very small or non-existent.
Seems stupid when the upside of helping suffering people (saving lives) is considered. Hate the bureaucratic overkill rules and regs of gov't.
No wonder the average cost of bringing a new drug to market in the USA is something like 2.6 billion and takes years and years.
There has to be a better way.
Today sitting at 6 but it would be fairly easy for it to go to 8,10,12...., or even make an immediate jump to 15 or 20.
It wouldn't be a huge surprise to the believers here if the BP feelers are not only out, but if one of them (they all are sitting on multi-billions in cash and need new drugs) pulled the trigger early and made a preemptive BO bid.
That's why if you believe it's not only impossible to be out here, but you might even be hoping it goes even lower to add more.
This is a very interesting situation- a definite contender for the best current risk/reward in the biotech space.
".......he has a great moral compass.."
I agree he really seems like the real deal- brilliant, driven, compassionate, highest integrity, etc. I think it carries over to the whole team from what I can see.
Way too rare in biotech as some of these guys make you think they were once carnival barkers or used car dealers, etc.
Apologies to the rock solid carnival barkers, car dealers, etc.
cheers
"..... the test subjects are healthier than the p2 test subjects."
Question about the above: On the one hand, the P2 results are so excellent it has to generate excitement among the LN doctors/patients which should translate into a quicker enrollment period. But wondering if stricter standard (healthier patients) plus the higher number needed nullify that premise?
The biggest winners right now are probably the funds who want to accumulate- I think they have a genius in manipulative ability, so they get to torture all the retail holders to the point where some will lose interest and bail.
Patience is tough but I'm convinced is required here. Still looking for something not to like and not finding it- the more I learn about this the more I like it.
This could be a monster for whoever can wait it out.
cheers
Blast from the past-2013 article on Glickman
“What we have going for us is being very successful in delivering to investors, delivering on the promises you make when you present your dreams,”
http://www.timescolonist.com/business/aspreva-drug-spinoff-targets-lupus-1.705980
Assuming you own this, was there a time lag between when you first learned of AUPH or did you just jump in immediately?
Some people have to research ideas first before investing; ie., they take a time out for mental digestion.
The MF articles may yet have an impact- too early to know
Those government numbers are wrong (no surprise)
Actual success rate for P3 is 62% for AutoImmune category
And Aurinia's odds are much higher.
"This is the largest study of clinical drug development success rates to date. Over the last decade, 2006-2015, a total of 9,985 clinical and regulatory phase transitions were recorded and analyzed from 7,455 development programs, across 1,103 companies in the Biomedtracker database."
See Page 11
https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%202006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf
"......thanks for the testimonials on your link."
Thank you for that comment. It's so easy for us to become so focused (obsessed?) with the price fluctuations/projections of the stock we can momentarily overlook the primary reason the Aurinia team exists- to help those brave people who are challenged every day with this tough disease.
It's inspiring as well as educational to read some of the first hand accounts from people who are right on the front lines of the daily battle dealing with LN.
can't resist adding:
“Curiouser and curiouser!” cried Alice
"....a riddle, wrapped in a mystery, inside an enigma..."
Quite a puzzle on many levels here.......
cheers
"It ain't what you don't know that gets you into trouble. It's what you know for sure that just ain't so."
Mark Twain
"There is a misconception that CellCept is a chemotherapy drug. It is actually classified in a group of drugs called Antiproliferative Immunosuppressants."
http://forums.webmd.com/3/lupus-exchange/forum/703/5
"CellCept, made by Hoffmann-La Roche Inc., is approved by the Food and Drug Administration to prevent organ rejection in transplant patients. But some doctors prescribe it to lupus patients who cannot tolerate chemotherapy."
http://www.nbcnews.com/id/10181868/ns/health-health_care/t/drug-helps-treat-kidney-issues-lupus-patients/#.WXM2Y4jys2w
The Fool strikes again- 4th AUPH article- again after market hours
"3 Hottest Biotech Stocks of 2017 -- Are They Still Buys Now?"
https://www.fool.com/investing/2017/07/20/3-hottest-biotech-stocks-of-2017-are-they-still-bu.aspx
Dr. Glickman comes across as a true professional- honest, confident, optimistic without any hyperbole- rare qualities too few match
Read his own words:
"Aurinia Pharmaceuticals: A Speculative Savior?"
Finally, Cramer took up a former caller on his request to learn more about Aurinia Pharmaceuticals, a small-capitalization, development-stage biotechnology company known for its lupus treatments.
The "Mad Money" host went straight to the source with Aurinia's CEO, Dr. Richard Glickman, to learn more about the company's leading drug, a Phase-3 treatment for lupus nephritis, a condition where lupus causes kidney inflammation.
Glickman told Cramer on Monday that while the clinical trial process is not always optimized per treatment, which can cause problems in how the results are perceived, treating a specific kind of lupus gave Aurinia an opportunity.
"At least in lupus nephritis, when you're looking at proteinuria, or protein in the urine, if you could drop protein in the urine down to a normal level, that has a big implication for patients. It makes it easier to study and easier, eventually, to get regulatory approval for," the CEO told Cramer.
Glickman is currently leading the company through its Phase-3 trial of its top drug, which will involve 320 patients and 200 sites around the world. Aurinia is aiming to reproduce the successful results of the drug's Phase-2 trial, which Glickman hopes would lead to regulatory approval. But watch where you invest, the CEO warned.
"These are speculative stocks. They are. And I think that's a reality and I think people, when they make a decision, they should do their homework," Glickman said. "They should really understand the diseases they're investing in and the program they're investing in and the quality of the management they're investing in. I think we have an excellent opportunity ahead of us. There's no guarantees, but I think when you look at a risk profile, I think we look pretty good."
http://www.cnbc.com/2017/07/17/cramer-remix-why-its-still-worth-owning-procter-gamble.html
Thanks for sharing your vast expertise- not only comprehensive but highly comprehensible for the non-experts.
You never disappoint!
cheers
Yup, probably would have only dropped 65 cents instead of 67
Cramer said he was glad Dr. Glickman said it so he wouldn't have to.
I'm sure the ultra cautious CNBC lawyers insisted on that being said.
I still can't fathom why "speculative" is perceived as negative when it's actually a big positive as small risk tends to equal small rewards.
If Dr. Glickman had stated this is a safe investment that would have made me cringe and probably bail. The fact that Glickman belongs to the too rare breed of being an honest to God straight shooter is a huge deal and confidence booster, along with the 29 other positive attributes Aurinia has going for them.
Anyone long term here should be thinking multi-bagger and that presupposes risk. If you can trade like the big boys, then theoretically at least you can greatly reduce the risk.
Lots of the secondary fund buyers are probably in this at $5 or less by now..........but I also remember the legendary Bob Duggan buying something like 500K+ shares at $8.85 so you know he only made that purchase because he considered it seriously undervalued.
The downside of trading this is a midnight surprise happens and you are caught too light and the price rockets.
cheers
Thanks and kudos to you for setting up that venue- an oasis of sanity from the wild west show in other places. Although maybe currently a somewhat undiscovered gem, I see growth ahead as this story progresses and the word becomes more widespread that a source exists for real substantive info re all things AUPH. You guys are a class act!
I missed a highlight before- I give Cramer credit for at least learning about and presenting the Aspreva Pharmaceuticals story and the development of Cellcept, the current SOC.
It is probably a severe understatement to say that the Aurinia team knows quite a bit about Lupus Nephritis.
Despite the flaws in that brief "Mad Money" segment, there might be a few parties of substance who choose to further investigate this compelling story.
I am confident greater things are coming here in the future as the story continues to unfold.
cheers
"Glickman was cool, calm, and collected even when Cramer railroaded him."
Your entire post is right on the money. Character counts! Wondering how so many are missing the big picture here as this company has it all: Great science, great management, great experience, great vision, great integrity.
The interview was a net plus for Aurinia- no one can currently measure the magnitude of what shakes out of the added positive exposure this company just received.
It surprises me that anyone can possibly see that event as a negative.
Attributing the drop in price after the interview to Glickman is a red herring and a false narrative.
The gripers are mistaken in that belief- you nailed it earlier when you portrayed it as an orchestrated manipulation by the WS sharps.
They are definitely clever, if devious.
After celebrating this most recent windfall they pocketed, they will congratulate themselves even more if they can get another chunk of retail buyers to bail out by driving the price even lower and discouraging them. Then they reload with cheap shares and strike again; wash, rinse, repeat........
Quite the spectacle we are witnessing- very high entertainment value.
The long term holders will win in the end here.
cheers
"I am afraid I find that I can not agree with you."
No worries- I learn more when people disagree with me. I guess I'm in the minority as I see the statement as a positive because I subscribe to this definition: "Speculative stocks are favored by speculators and investors because of their high-reward, high-risk characteristics."
This is clearly a high risk, high reward situation, which is a big part of it's appeal to me. And what boosts its appeal further is that the P2 results were not just good, but exceptional, thus mitigating the risk.
Glickman was trying to point that out to Cramer before he was drowned out.
I continue to believe this stock represents extraordinary value and the patient investors will be well rewarded.
.........and the traders will get lots more opportunities since we're 2+ years out if there is no early buyout, which is why the investors have the edge here.
Patience is the key here, imo
cheers
".....it was agreed on before the interview that phrase had to be mentioned...."
That sounds right- I think the critics are thinking like traders and not investors.
From the investor point of view, Glickman did a good thing as many/most of Cramer's audience are not that sophisticated so he further demonstrates high integrity by protecting them from themselves. No one could accuse Glickman of being another bio hype artist.
The negative feedback on this reminds me of when the secondary was done at around a 25% discount to the market.
Glickman is very confident and believes in this drug. He's thinking long term and about investors and not about the interests of "here today gone tomorrow" day traders.
My only complaint re the interview was that we needed more Glickman and less Cramer.