...SCAM this company is? Geez! Six to $32 and back again -- what a racket! Of course, the brokers banking commissions probably laughed themselves silly the entire time! Nevertheless, given the REAL value of this company is LESS than ZERO, there's plenty of downside left. What truly amazes me is how these things ever manage to come public to begin with!
...let me count the ways -- oh, here's one, "CNAT"!...
...so Pfizer acquires "Idun" and "idn-6556" in 2005 for "undisclosed" terms...five years later CNAT buys BACK "Idun" and "idn-6556"?...why did Pfizer sell?...I presume it wasn't because of all the "wealth" they were anticipating from future sales of the drug...
...from the 10-Q, say what:
"In July 2010, the Company entered into a $1.0 million promissory note payable to Pfizer Inc. The note bears interest at 7% per annum, which is paid quarterly, and matures on July 29, 2020."
So Pfizer even lent them the money to buy Idun and idn-6556 back???? And I presume a million bucks was roughly the purchase price, which tells you how much Pfizer thought it was worth.
Then CNAT spun off Idun to shaeholders and valued it at a whopping $500,000, which I guess means that "idn-6556" is really roughly worth only $500,000.
But in 2013, Jesus apparently walked on water again and made CNAT worth a 69 MILLION dollar IPO? Can I have an "amen"?
Then look at the phase 2 trial -- "primary outcome measure" is "Pharmacokinetics." SECONDARY outcome is "clinical outcome measure."
Seriously? Funny, I always thought phase 1 was pharmacokinetics, while phase 2 was dosing and initial establishment of "clinical outcome" measures according to dosing.
I saw enough at that point. Pfizer's "loss' was Wall Street's beokers' gain. I can only hope there aren't too many naive enough to buy into whatever hype is coming.
...just happened to stumble over the PR about ACUR "settling" its lawsuit against Sandoz -- lengthy, complicated PR that really boiled down to one sentence:
"...Sandoz is not obligated to pay Acura a royalty if its current formulation of its generic to the AVERSION..."
...it took EIGHT paragraphs to say that?...I wonder how many ACUR executives it takes to change a lightbulb!...HAW!!...
I also like that comment:
"Acura's President and CEO, Bob Jones said, "We are very pleased to have now concluded all our patent infringement suits concerning AVERSION oxycodone..."
Gee, Bob, you're happy you LOST? A little overly sportsmanlike of you, I must say! Especially considering how many millions in shareholder equity you presumably flushed down the toilet trying shakedown Sandoz!
Interesting quote from an article entitled "Notch nicked again" in 2011:
"When preclinical studies last year suggested that broadly inhibiting signaling through the Notch pathway runs the risk of triggering tumors in endothelial tissue, two companies—Roche's Genentech Inc. unit and Aveo Pharmaceuticals Inc.—tried to sidestep the adverse effects of pan-Notch inhibition by selectively targeting Notch 1. Now, a new paper from Washington University in St. Louis researchers suggests that Notch 1 inhibition may also cause tumors."
...and it goes on to say:
"Although some academics say the entire class of therapeutics should be abandoned, at least one company—OncoMed Pharmaceuticals Inc.—thinks it's still business as usual because the gene knockout data that underpin the new study do not agree with the company's preclinical results."
...well, of course not!...you've got a half dozen venture capital funds breathing down your neck to do an IPO so they can rack up a mountain of cash, you darn tootin' that doesn't agree with YOUR preclinical results!
“We have shown mechanism-based toxicity,” said Kopan. “It's enough to remove just one receptor—NOTCH1—and you have toxicity. This says that the therapeutic window for drugs that target NOTCH1 is extremely small....“Endothelial cells must have NOTCH1 signaling to prevent them from proliferating uncontrollably,” said Kopan. Thus, he thinks that the findings do not bode well for therapeutics that target NOTCH1.”
...dang, somebody wanna shot that sonofagun before he botches our IPO!...
...ohhh, not you too:
"“Notch signaling is one of those pathways that are exceedingly dosage dependent,” said Artavanis-Tsakonas. “If you lose Notch signaling, you change the fate of cells. There's absolutely no doubt that if you start fiddling with Notch signaling there will be consequences."
I'm tellin'ya it's just a plot to impoverish OMED's management! That''s all! Just ignore all those jokers!
Well, afrezza has been running around the treadmill for what -- 7 - 10 YEARS? So it's safe to conclude ALL diabetics know about it, okay? Now, google "diabetes forum afrezza" and cruise through a few to get some idea how excited they are about the approval. Random quotes:
"Lungs being one of the more vital body functions, I can't imagine agreeing to a new drug not knowing the long term effects."
"I just don't understand how it could be precise enough for use with type 1."
"...my mind just does not go there. Maybe it's because I'm asthmatic..."
The most excitement I could find was the father of a kid who was happy to "welcome a new tool"! Too bad it'll be another THREE YEARS plus who knows how many millions (billions?) of dollars more before his kid even has a chance to try it!
Indeed, I couldn't even find afrezza mentioned on several forums!
Face it! Diabetics could care less about afrezza! The ONLY people "excited" about afrezza are stockbrokers and stock pumpers. Why? Because they want to selI STOCK and could less aboout the reality in store for afrezza.
I just happened to read that poater that ORMP presented May 14 and what did my little eye spy the DOSE of "ORMD-0801"!...it was 460 units of insulin! Got that? Four HUNDRED and SIXTY units! That's TWO ORMD-0801 pills, by the way.
Let's see, at around ten bucks per 100 units, you'd be looking at $50 per NIGHT, or roughly EIGHTEEN THOUSAND dollars per YEAR -- for insulin!
And what miracles will the patyient get for that money? Are you ready for this? You might want to sit down! Anyone with a heart condition may want to stop reading at this point! After taking 460 units of insulin orally at bedtime, the patient gets -- can I have a drum roll please! -- gets a 26 mg/dl reduction in NIGHTTIME mean glucose!
And that was versus doing ABSOLUTELY NOTHING at all! Yessir! Those that got the placebo had average glucose concentration of 165 while those that got the GARGANTUAN dose of oral insulin averaged 139!
Sweet bejeeeezus! They didn't even get them into the normal range with FOUR HUNDRED AND SIXTY UNITS!!! And note that ONE UNIT of SQ insulin should be able to reduce glucose by about 40-50, so Orascam's product could do barely HALF of what ONE UNIT SQ could do!
In other words, to achieve an effect equivalent ot SQ insulin, a patient might need to take upwards to NINE HUNDRED UNITS of ORMD-0801!
And on top of all that, ORMD-0801 had NO effect on the daytime mean and NO effect on the fasting mean!
On the bright side, they FINALLY admitted that their "8 mg" pill translates into a HUMONGOUS dose of insulin!
...gee, what a bunch of suckers!"...total lack of transparency ..."highly unusual"???...not really...not if you ain't got no "potential partners," it ain't!....remember this:
"We made substantial progress toward a definitive agreement with a lead potential partner; however, as the discussions progressed, we came to believe that it would be more productive to complete a partnership after we have received a response from the United States Food and Drug Administration, or FDA, regarding our new drug application for AFRESA."
...that was from 2009!....FIVE YEARS go!...hmmmmmm, "WE came to believe"?...say what, Mr. Analyst:
"In fact, negotiations with the partner were so advanced that MNKD ceased talking to other potential partners. Term sheets apparently were set but the partner reportedly withdrew after review with its regional commercial managers, who were not included in the negotiations until the end but ultimately raised objections regarding the deal."
...oh, yeah!...right!..like you wait until a deal is almost completed, and THEN ask for an opinion from your "regonal commercial managers" -- yeah!..uh-huh!...gotcha!...hey, probably better than just coming out and confessing there were NO "negotiations" to begin with, right?...
...at that statement on OMED's website:
"To support the advancement of our clinical-stage candidates and our continued discovery efforts through commercialization, OncoMed has assembled a proven management team with expertise in oncology research, drug discovery, clinical development, translational medicine, regulatory affairs, and commercial development. In addition, we have established a strong patent portfolio protecting our novel anti-CSC candidates, as well as our platform R&D technologies. We have formed strategic alliances with Celgene Corporation, Bayer Pharma AG and GlaxoSmithKline. Since our founding in August 2004, we have raised approximately $622 million, consisting of a blend of equity financings, including an Initial Public Offering, and collaboration funding from our pharmaceutical partnerships."
Wow! I'm impressed! So how many drugs have you got on the market? "Uhhhhhhh...none."
Ooookay! Well, how many have you got in phase 3? "Uhhhhhhh...none."
Well, then, how about in phase 2? "Welllllllll...none! But, by golly, we got a sh_tload in phase 1!!!!"
Hmmmmm...let's review...10 YEARS..."proven management team"..."strategic alliances"...622 MILLION dollars...and they've actually managed to initiate some phase 1 studies? Well, hallelujah!
And the wheels on the biotech bus go round and round...round and round...HAW!
...just THIRTEEN DOLLARS???...per SHARE???...is that right?...oh, wow!...like yeah, sign me up to buy a few hundred thousand shares -- NOT!!!...and the CEO gets paid HOW MUCH a year?...note for my "to do" list -- take some loser company public and pay myself a LOT of money to make it an even BIGGER loser!...
I only just stumbled across it again. I vaguely remember laughing at it years ago when they said yhey were going to try to get approval to market wellbutrin as a weight loss drug and about fell over laughing...I remember wellbutrin became available as a generic just about the time these clowns went public SEVEN YEARS ago!...
...oh, look, and now they're mixing it with zonegran!...well, if mixing it with nalrexone won't work, why not!...if VVUS can get away ith it, why can't we!...HAW!...
...hmmmm...that reminds me, I wonder how those shareholder lawsuits against VVUS are working out -- the ones where the shareholders allege "breaches of the fiduciary duty...in connection with the launch of Qsymia...insider trading by some defendants for selling Company stock while purportedly being aware that the Qsymia launch would be less successful than predicted and corporate waste..."...corporate waste?...a biotech --- nawwwwww...HAW!...
...huh?...you say OREX already has its own lawsuits:
"...assert claims for breach of fiduciary duty, waste and unjust enrichment based on, among other things, the alleged grant of stock options to certain officers in excess of the 162(m) Award Limit, repricing stock options allegedly in violation of the Company’s equity incentive plan, the board of directors’ conduct in responding to the May 2013 shareholder demand, and making allegedly false and misleading statements"
...awwwwww...unjust enrichment???...come on!...just because management gives itself fat salaries, benefits, bonuses, and perks while producing next to NOTHING for shareholders, no reason to get mean about it!...HAW!...and "false and misleading statements"????...hey, it's a biotech, already!...that comes with the territory, right?...HAW!!!...
...three little Israeli scams!...four little, five little...well, you get my point...guess what -- I found another one this am!...I think I mentioned DRIO and its antique glucometer sometime previously, and this morning what did I find but a company called -- are you ready for this? -- "Integrity Applications"!!!...HAW!...is that rich or what?!
...anyway, IDAP has this marvelous non-invasive glucose monitoring system...unfortunately, they have hardly ANY money -- a million bucks or so -- so getting approvals and marketing are going to be kinda tough...and they also don't have any partners or, for that matter, anyone who appears even remotely interested in partnering...
...so, hey, maybe some of you suck...uhhhhhhhhhh..."speculative" investors might wanna bop over there help'em out!...why, heck, I worth they're worth every bit as much as Orascam!...HAW!!!...
...who cares...figure 52 million in cash but 32 million in DEBT at end of March!...burning 16 million a quarter means -- on balance -- they're now approaching BROKE -- AGAIN!...which no doubt means it's time to start chaining together some meaningless press releases in order to get ready to print some more stock!...let's see -- shares outstanding 2010 22 million, 2011 22 million, 2012 26 million, 2013 30 million, end of March 33 million...so before December figure another -- what? -- 5 million or so?...
...it's on their website...note that you can probably spit farther than you can trust positive results from ANY study done in China...also note that the paper included three VTL employees -- no chance of bias there, huh?...
...seventy CENTS in only two weeks of trading!...is that some sort of record or what?...what is it they're working on?...rose bengal?...for cancer??...the stuff they use to stain eyeballs when looking for corneal abrasions and such???......for CANCER????...uhhhhh, hold on a second..................ahem!..............................not much longer now!.............................................okay!...here it comes:
HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW, HAW, HAW, HAW, HAW, HAW, HAW , HAW, HAW!!!!!!!!!!!!
...oh, that was a good one!...man, I think I need to go change my depends!!!...rose bengal!...well, what else could you expect from the biotech braintrust in KNOXVILLE, Tennessee?!...HAW!!!...
Sentiment: Strong Sell
Oh, look, another DA that wants to argue with me...a quick history review:
Amgen: Founded 1983 -- epogen approved 1989 -- neupogen approved 1991 -- enbrel approved 1998...
Genentech: Founded 1976 synthetic insulin approved 1982 somatrem approved 1985 activase approved 1987 actimmune approved 1990 nutropin approved 1993 pulmozyme approved 1993 rituxan approved 1997 herceptin approved 1998...plus ten MORE that have been approved since then...
Oncomed: Founded 2004 Drugs approved NONE Drugs in phase 3 NONE Drugs in Phase 2 NONE
Timeline for appproval of ANY Oncomed drugs -- what, another TEN YEARS maybe? That is, IF any get approved since the the approval chances are likely one out of a hundred or MORE!
And all the while management rakes in big salaries, benefits, bonuses, and perks while stockbrokers stuff investor mailboxes with hype, and what do shareholders get? Promises and secondary offerings out the old wazoo!
Like I said -- and the wheels on the biotech bus go round and round, round and round...
VTL's "artificial liver"????
Warning signs -- first, publications. Two in 12 YEARS. The first one in 2002 was just a safety study that reported some results from five patients but nothing of relevance to patient outcome. The second was from 2007 -- " Interim Results of Randomized Controlled Trial of ELAD in Acute on Chronic Liver Disease" -- and reported some remarkable results. Problems -- it was done in CHINA (I note sudden flare of large red flashing lights in my peripheral vision) and the authors included THREE Vital Therapies' employees (whoa!...now I'm hearing very loud sirens!).
Second -- presentations. From 2010 -- "Safety and Efficacy of the Extacorporeal Liver Assist Device (ELAD®) in patients with Acute on Chronic Liver Failure" -- "survival data encouraging." Using the word "encouraging" when describing study results usually means it's NOT "encouraging." Interesting conclusions that the authors came to regarding future study design -- enroll patients with fewer complications, enroll patients with lower "model for end-stage liver disease" scores, use "prevention of disease progression" PRIOR to transplant/death as the primary endpoint. In other words, avoid sick patients, avoid patients whose livers are too far gone, and use "progression" rather than survival as an end-point. Why, of course! Why not exclude liver patients entirely and just drag in some perfectly healthy souls off the street -- that should produce GREAT results!
I guess the FDA didn't buy VTL's logic entirely because the presentations from 2012 and 2013 can be came to the same conclusion: "Differences in survival were NOT statistically significant." Is there any reason to believe that a phase 3 study will alter that conclusion? None that I can think of.
How does wall street manage to sell this stuff? It just amazes me that ANYONE with an IQ greater than a grapenut would plunk down even a nickel for this stock!