watching biotechs, gold & silver
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re LSE vs. LN
still struggling to comprehend: Does CR with Voclosporin mean the symptoms of LN are gone but you still have SLE?
Can the quality of life in that situation be quantified?
Thanks for any help
Thanks
"How anyone could bet against this and hope for bad news is beyond me."
Guessing there are few outright bets against it- I'm thinking short interest is hedged from recent offering.
Also guessing coming new institutional holding report shows a jump and stock trades higher
cheers
Nice Post!
You said " Thanks to his efforts, lupus nephritis may soon be one less complication that lupus sufferers have to deal with."
I'm still fuzzy on voclosporin- does CR mean there are zero negative effects; ie., that it's possible it approaches "cure" status?
Thanks in advance for any insight
FWIW- Impressions of the Board after reading msgs #1-current
Sort of blown away by the unusually high quality of the discussions- truly exceptional compared to any other board I've seen (admittedly not a huge sample).
Learned a lot and was especially illuminated by the extensive discussion(s) re P values and how they related to trial results, risk assessments, etc. Really impressive
Very few low grade posters (disingenuous, unbalanced, etc.) and nearly all of those were transients
KUDO's to you!
cheers
PS. At one point there was a somewhat extended discussion re short sellers and maybe the big jump in short interest recently- can't recall perfectly (don't get old).
Anyway, just wanted to opine that I don't think the seemingly high short interest will provide any substantial pop to the stock as I believe nearly all of it is hedged from the recent offering; ie., there aren't many naked shares short. Just guessing but it makes perfect sense to me as after the offering anyone with the new shares could have instantly made 20% or so by hedging their shares at the market, and they had a week or 10 days or so to accomplish that as the market price stayed above the offering (6.75) price, which I thought was odd. I'm guessing the reason the price stayed so high for so long was due to very high (extraordinary) investor interest generated by the stellar P2 data.
Upcoming for AUPH
per Ronald Liu@RonaldLiu3
May 11 - Earning Report
May 15 - Tute filing of ownership
cheers GLTA
Thanks Kim- same to you!
This article is an oldie but a goodie re the recent AUPH offering of 22.3M shares @ $6.75
https://www.thestreet.com/story/14041933/1/twitter-traders-yap-but-aurinia-raising-150-million-was-a-well-executed-deal.html
I especially like the quote from a former healthcare hedge fund pro: "Funds getting in today aren't playing for a few dollar move, but a multi-bagger. If you liked that data, this is the time to add. Forget about clipping it for a buck."
— Biotech Hack (@BiotechHack) March 13, 2017
Seems to perfectly echo the sentiment/thinking of the seasoned veterans here.
Really clear that AUPH management is a really good group.
cheers and GLTA
Thanks Lunacy. I need to read more slowly- didn't realize the rolling NDA was also part of Fast Track. Went back to the FDA descriptions and see that the major difference seems to be that the BTD gives more intense FDA hands-on assistance during the process.
Thanks for the help. Have to say this is a generous board.
cheers
Tobey- thanks for sharing that- thoughts and prayers for your friend.
While difficult to process, I appreciate hearing real stories like yours as it raises awareness; I thank God for the patient advocates who have the courage to put themselves out there; truly selfless love.
Wondering if your husband has an opinion of voclosporin? Lupus is so clearly complex I can appreciate both the hope and the skepticism as well.
Thanks again and best wishes to you and yours
Kim,
Thanks so much for your kind and heartfelt words- much appreciated.
The good news is that my gem of a friend Stephanie suffers no more and I've experienced the evidence of that firsthand. I've personally gained as well by a newfound (or rediscovered) appreciation for what is truly important in this often mysterious, wild ride we call life.
I'm tempted to go over the TOS line here so with some restraint I will just say if we make a direct appeal to the Almighty He will help us through everything.
If I just crossed the line, see you in 30 days :)
God Bless You and yours
GLTA
Thanks for your quick and comprehensive response. Good to know IR will respond so I will ask them.
I know little on this subject, but am thinking that since the need is so great and the already demonstrated science appears so compelling, the faster the better so wondering how these approval paths work; ie., what criteria is necessary to move as fast as possible thru the bureaucratic labyrinth of the FDA?
I'm struck by the suffering that LN brings to so many. A dear friend passed away from LN a few months ago so I have indirect, secondhand experience re how the patients struggle with just trying to live a somewhat normal life.
Really hoping this succeeds in a big way for multiple reasons.
GLTA
Thanks for the clarity and correcting me re "accelerated approval".
So, Voclosporin is currently "fast tracked" but can reapply for "breakthrough therapy."
Is there also a possibility they can also attain "accelerated approval" at a later date?
Thanks again- much appreciated
Query re Breakthrough Therapy vs. Accelerated Approval FDA Designations:
Fairly new to AUPH and trying to understand it better so need some help if you can.
I believe I read that AUPH received "Accelerated Approval" designation but applied for and was turned down for "Breakthrough Therapy" designation which I think would include more frequent FDA contact, rolling NDA, etc.
If this is accurate, I'm curious why voclosporin wouldn't qualify for BT as nothing approved for LN for decades, etc.
Thanks in advance for any help/clarity on this.
GLTA
Apologies if this 2 month old article has been posted- I love the following excerpt from it:
".....while cautious onlookers were concerned that the drug would lose efficacy over time, the opposite happened and it stayed durable between 24 weeks and 48 weeks of treatment.
Arce said that he is even confident that longer-term therapy could result in the majority of participants reaching complete remission – as the company has still not yet found a plateau. HC Wainwright predicts a successful Phase 3 AURORA study that is de-risked, and think that the first uptake right after it’s commercially launched will be positive. The firm sees voclosporin as the emerging standard of care for LN."
http://www.economiccalendar.com/2017/03/03/more-upside-for-aurinia-pharmaceuticals-auph-even-after-2-day-rally/
While I'm confident Bob Duggan is wrong on Scientology, he certainly has demonstrated remarkable ability in the biotech world. I really like that he is getting in heavy.
GLTA
>>Just feel it, something is in the air.<<
Could be, but an alternate explanation might be that air traffic controllers always feel something is in the air.
How ya' doing buddy?
cheers
food- will you stop shouting?
I have a headache
Here's a post by Gary Rogers with his handle- "garogers45"
http://messages.finance.yahoo.com/Business_%26_Finance/Investments/Stocks_%28A_to_Z%29/Stocks_C/thre...
>>Because the Yin/Yang nature of GABA and Glutamate seems to be a topic of discussion on this board, perhaps I might be allowed to make a couple of points. While I do not now (nor do I encourage others to) race cars through the canyons near UCLA, when I did (about 1970), it was a well-known fact that horsepower was indeed important - but so were brakes. Thus, it was that a little Minicooper S was the king of the racing hill. It had great brakes, and ok, it wouldn't tip over. Ninety HP 356 Porsches were pretty good, too - for the same reasons.<br><br>So it is in your brain. Excitation (glutamate; horsepower) is pretty dangerous without inhibition (GABA; brakes). You can only go as fast as your brakes can slow you down. Thus, if there is in fact a dimunition of GABAergic tone with ageing, then increasing GABA release could improve memory. Another way to look at it is in terms of signal to noise ratio. If there is too little GABA, the noise level will be too high and a glutamatergic signal will get lost.<br><br>And a small correction because I was quoted as saying that "the literature" reported that modulating AMPA receptors could increase GABA release. Dr. Amy Arai, working in Prof. Gary Lynch's lab, was the first to show that Ampakines could increase GABAergic activity by their action on AMPA receptors - a seminal finding.<br><br>So, wouldn't you like to have more horsepower and better brakes?<br><br>Dr. Tracey's discussion on the subject was much more erudite than the one presented here, but perhaps this will be an additional aid. <br><br>As for CREB and Tim's "master switch" - would you use a circuit breaker to turn on your reading lamp?<<
Dr. Rogers posting on Yahoo MB-
Looks like it was in May of '03- here's a post by gfp referencing that- too bad Yahoo posts are no longered numbered.
http://messages.finance.yahoo.com/Business_%26_Finance/Investments/Stocks_%28A_to_Z%29/Stocks_C/thre....
Aiming- Maybe try using the search feature on YMB- it's fairly good
cheers
>>.....my guess is someone out there knows something-....<<
I don't think so - I think yesterday's bump was 99% due to the Rodman BUY recommendation (a reiteration) yesterday.
>>We all gotta learn to keep a level head through the ups and downs .........<<
All of us? Surely you jest. How is that going to happen?
cheers
>>......what are people here thinking will happen to COR's share price if the company gets a good decision from the FDA on the IND?<<
I think $2.70 to $3.70.
Then $5-7 after a BP deal
The last 2 dilutions will hold the price back
We're in much better shape than I thought!
WARNING- Gallows humor ahead
Look whose COR's direct competitors are!
http://finance.yahoo.com/q/co?s=COR
We're in pretty good company- confidence restored!
cheers
jerrydylan- little help, please
you said >>The money flow has been improving dramatically on the worst days with the most volume like yesterday, I think it wll be positive soon-.......<<
What software are you using to calculate money flows?
TIA
>> Does anybody have any thoughts on this?<<
Well, COR wants to put a drug into people's brains (maybe even little kids), so you can understand why the FDA would be cautious.
All the delays make sense in the context of how the whole odyssey has unfolded for COR to date.
While the goal seems to be constantly receding on the horizon, it all seems reasonable when you examine the details of why.
The latest delay is because COR wants to explore the utility/value of a new Ampakine use- you can't fault them for wanting to do their job; ie., find out how and where these drugs can benefit mankind.
They're walking a tightrope/razor's edge between successfully securing sizable BP R&D funding and being forced to dilute again.
Will COR win the race or ?? To me, that's the bet/risk we're taking.
Seriously, this isn't anything new- it's a moving target.
You're welcome- glad you found it helpful
GLTU
cheers
>>What should we be talking about now?
I'm not worried at all about what management did in the past, I am SCARED what they will do in the future..<<
One positive thing you might do is consider various strategies for recouping your losses.
Here are some possibilities:
1. Consider doing nothing (buying or selling) for a couple of weeks, until COR knows the status of the IND for ADHD.
If it's a go, consider buying more as the trend will likely be up.
If it's a delay, prepare for the price to re-test the $1 level, and then consider buying more after the dust clears and/if the future looks hopeful again.
2. Consider the "basket of stocks" philosophy, always a good idea with small biotechs as a hedge against situations like this.
There are lots of small biotechs or techs that have similar risk/reward profiles as this one.
3. Consider the possibility that your basic nature/constitution is not suited to be invested in this area.
No shame in that- if that's the case, then you can consider either holding or selling.
etc., etc.
Just some thoughts that seem sensible to me
cheers
>>.... I should have learned from his mistake to voice a different opinion than rah rah.<<
You're overly sensitive. I don't believe anyone objects to your having a different opinion.
The objection is that you persist in rehashing it over and over, well past the time that everyone "gets it".
No big deal- lots of us have been called out by fellow posters for the same behavior, including myself, gfp, as well as Jim.
I think the board is bored with the "management sucks" routine.
We are where we are- time to look forward.
Why not give it a rest and present something new or different?
cheers
>>........the top 10 or so holdings in the report and I don't think COR fits on any of those lists....<<
Excellent point- forgot about that.
You have to be right- COR couldn't be on any Top 10 list yet.
Thx
can the sell off in COR be "window dressing"?
The quarter is ending and lots of stocks are moving up or down in order to make the portfolio managers look good.
Can COR somehow be caught up in this maelstrom, or is it so tiny that it is immune to this phenomenon?
TIA for any insights on this
cheers
asuhowe- you said
>>Is everyone crazy on this board, rich enough to throw away $$, or ??..<<
The only guy I know rich enough is JimHaynes.
Seems odd that somehow you missed all of his posts- he expresses virtually the identical sentiments as you do.
I think he's on currently on sabbatical, but you should definitely read his past posts- if you're looking for someone to commiserate with, he's your man.
While Jim may be absent at the moment, your posts provide a nearly seamless transition; like he never left.
cheers
>>I sent an email to the IHUB Gods asking for instruction to "unsubscribe." <<
Maybe just take a vacation from it- this board is rarely (if ever) this intense, uptight, stressed, etc.
If you are really intending to not return, kudos for the awesome early warning that a PIPE was likely.
I wish I had paid attention- got totally blindsided on that, probably like most on here.
GLTU
cheers
>> .......I'd also like to hear from Urko if he happens to be swinging by the Cortex tree.....<<
Welcome back- must have been great to get away from it all.
Just curious- I've never understood the fascination with Urko. I never saw him post anything that was prescient or even useful.
Obviously, I'm in a minority on this- so what is the deal?
TIA for any feedback.
cheers
>> I can say that I would expect the upfronts to be somewhat higher than originally anticipated. We view CX717 as critical to the development of our platform and are vigorously pursuig the best deal possible."<<
The cynic in me says, "somewhat higher"?- Oh, you mean like $31 million?
So, you are now "vigorously pursuing the best deal"?- Sure, just like you did when you made us all bagholders by not only giving away the stock at $1 and $2, but adding insult to injury by throwing cheap warrants into the deal to make it an even bigger travesty.
No way- not even close- no contest.
Hands down winner is Roger saying $30-$50 million in upfronts.
I applaud his statement as is- if he expressed it as in your suggested version, it just sounds like he's already caved, given up, surrendered, etc. as it just comes across weak, imo.
It would be one thing if Stoll listed all the things the $30-$50 million would buy, but he didn't- he just expressed what he's looking for in upfronts.
This is confidence boosting, reassuring, etc. because:
1. Stoll is not a BS artist- he's credible probably to the point of being too low-key, understated, etc.
2. This is consistent with the extra punch virtually all of the biotech deals being done since the first of the year or earlier are getting- this is the richest bio deal making market in years.
The BP deal is Stoll's "white whale"- he really needs to land it this time as it's been eluding him for years.
I think he's got it just right- now it just needs to get done.
Patco- just a couple more metaphors
>>.....it is more than a 'one pony show'.<<
True enough- and if it's a "dog and pony" show that's OK, as long as it doesn't become exclusively a "dog show".
Do me a personal favor- consider changing your mantra "till the last dog dies" to "until the last pony dies"- it just sounds more postive.
cheers
Patco- definitely worth a listen
55 minutes plus in total, 38 minutes of just Q&A-
Dew posted the webcast link-
Nothing like the direct, unfiltered version
http://www.investorcalendar.com/IC/ClientPage.asp?ID=120892&CID
>>....... let's say that a 200 patient, well-designed phase IIb study over six weeks will cost 8-9 million dollars.<<
How do you calculate the cost per patient of running clinical trials?
Are there formulas out there where the variables are plugged in?
TIA
>> It is extremely important for a CEO of a public company to deliver on his promises.....<<
I don't think the things that didn't happen were actually "promises", but rather "forward looking statements", that are always subject to change.
While things probably haven't too often unfolded the way they were initially presented, that basically seems par for the course in the often wild and wooly biotech world.
From what I've observed over the years in looking at a number of different small biotechs, nothing ever seems to unfold exactly as planned for any of them, as the landscape seems to shift fairly rapidly.
Out of cliches.
>>Here's the Devil's Advocate position...<<
Ouch! Actually, thanks for the realistic view, as painful as it is.
It appears that COR is walking a tightrope of sorts, at present. I'm wondering how they get to the goal, and now even wondering what the goal looks like?
Somehow they need to get the best deal they can get before the PIPE money runs out again.
Considering COR's present position, can/will you venture a speculation/idea what a realistic, good deal for COR would be under the circumstances?
I realize that you may not want to, since the reward for doing so is most likely a beating from some quarter on the board, which appears especially testy at the moment.
Hoping this is a sign of a bottom and not an apocalypse precursor.
Thanks again for the feedback and any additional commentary.
Your take on it all is very valuable- always insightful, often somewhat surprising.
>>I still believe that Stoll has placed a value on COR that is in the stratosphere – a value that even the most hungry BP is having difficulty accepting. <<
Curious why you would say that?- I'm concerned that Stoll will commit the blunder that past CEO's have done here- get backed into a corner and be pressured into a bad deal.
Look at the recent ARIA deal with Merck- why can't COR do a similar deal?
ARIA got $75M cash in upfronts, and a total of $1B in milestones. Sure, most of the billion is in "biobucks" that will likely never be seen, but the $75 million is real.
I know they are different companies, but COR is a hot property with a big platform and excellent science, and the bio deals that are getting done are the richest in years.
Although the recent PIPE hurt the shareholders, if it leads to a major BP deal on excellent terms, I would say that Stoll had redeemed himself, and then some.
>>.....what COR needs to make a top priority is to hand-pick a great deal-broker/salesman.....<<
This sounds right- I've also been thinking/considering what is missing here and why success seems to always elude COR.
Lately COR has had more than it's share of bad luck, but it seems there is more to it than mere luck.
Let's face it, Stoll is not the greatest pitchman- during the road show presentations he generally comes across as fairly uncomfortable and ill at ease, like he doesn't want to be there and can't wait for the show to be over.
The makeover route seems unrealistic- I can't see Stoll signing on with Tony Robbins, getting all pumped up, etc. Can you picture Stoll doing the "firewalk"? I can almost hear "Ow! Damn that's hot! What the !@#$%!!! are you doing to me!!", etc., as he runs across the hot coals.
Nope- I think the paid consultant route is the way to go for COR, just as they did in hiring the FDA consultants to finesse the artifact issue.
In order to successfully conclude a BP deal, I think they need someone like Louis Winthorpe,III (Dan Aykroyd), who gave Billy Ray Valentine (Eddie Murphy) this pep talk in the modern classic, 1983 movie, "Trading Places":
"Think big, think positive, never show any sign of weakness. Always go for the throat. Buy low, sell high. Fear? That's the other guy's problem. .......it's either kill or be killed."