...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!
"The # of units of insulin per capsule is not the issue."??????
Geez! Are you a total DA or what? The FACT that their idiotic pill requires NINE HUNDRED units of insulin in order to just match the effect of only ONE unit of subcutaneous insulin demonstrates CLEARLY that their "magic formula" is effectively WORTHLESS! The driving idea behind developing an oral formulation is elimination of injections., but a typical type 1 diabetic would require around a HUNDRED ORMP pills a day!
As far as affordability, has ORMP figured out how to handle that? Don't think so! How long might that take? I dunno but the demand for insulin is already huge and competition is already extreme so I'm inclined to think insulin prices aren't going down anytime soon.
Moreover, the issue is not simply affordability. You're putting into a patient's body enough insulin to kill them a half dozen times over! What if someone has a bleeding ulcer and the pill dissolves nearby; how much might get into their bloodstream? What if someone develops an inflamed bowel and the mucosal barrier breaks down -- how much more insulin might they absorb? Etc, etc...
It's like asking the diabetic to put a gun into their mouth while ORMP holds the trigger but reassures the patient that ORMP knows what it's doing and the gun surely won't go off!
I had to laugh at a review article by Heinemann and Jacques:
"A number of companies have claimed to be developing an oral insulin formulation. However, it is not easy to evaluate the level of activity of these companies. It appears as if some companies have vanished or are not interested in this topic currently (e.g., AutoImmune, Biosante, Coremed, Cortecs, Eligen, Nobex, and Protein Delivery). Most of the developments of these companies have failed in phase II clinical studies, showing insufficient metabolic control in patients with diabetes."
The two words you should focus on are "claimed" and "vanished" since both will apply to ORMP a t some point.
Well, ORMP has been doing their "research and development" for at LEAST nine years since their first "trials" were reported back in 2005.
Now, maybe you're "patient" and perhaps willing to wait another NINE YEARS for a "miracle," but NOTHING will change the FACT that ORMP's pills contain 230 international units of insulin each and ORMP's "magic formula" appears to do absolutely NOTHING to enhance absorption. I suspect you could just squirt 460 units (the usual ORMP dose) of injectable insulin into a patient's mouth and let them gargle it for a few second and get as much or more effect as ORMP's silly pills.
And I have no doubt ORMP's management as well as the brokers' pitching the stock as well as M. di Stefano know all this but could care less since, regrettably, money usually triumphs over truth.
...from a 2005 Datamonitor article entitled "Pfizer makes an aggressive move into treatments for liver disease":
"Datamonitor's estimation is that Pfizer spent $50-150 million acquiring Idun and it is likely that the company has seen more than the currently available Phase IIa data for IDN-6556. An antifibrotic therapy could well be a future blockbuster - what remains to be seen is whether Pfizer was just too late in acquiring the best direct HCV antivirals, or is one step ahead in dealing with chronic liver disease with IDN-6556. Datamonitor's opinion leader panel expressed the following viewpoint: "Depending on the safety and efficacy it [IDN-6556] may be used as a more broad anti-inflammatory even in other kinds of liver diseases, including auto immune liver disease. So...they need to go about it sequentially but there is still quite a bit of data that needs to be generated."
So, NINE YEARS ago, Pfizer buys Idun for "$50-150 million" and then presumably "generated" over the next five YEARS "quite a bit of data" and then FOUR YEARS ago sells Idun back to it's original founders for around a million bucks? And not only that, but it appears that Pfizer actually lent them the money needed to buy back? I guess it's safe to infer that "quite a bit of data" didn't make Pfizer very happy, huh?
And what did CNAT between 2010 and the IPO to "improve" things? From their website, I see four mouse studies presented as "posters" and another poster that involved a three month study of humans and concluded "apoptosis and caspase activitiy remain functionally intact and thus may minimize concerns regarding safety."
The mouse stuff is irrelevant. The operative word for the other study is "may." Cancer is a LONG term concern and "may" over three months isn't likely to satisfy FDA reviewers.
...a quote from the article," Oral IDN-6556, an antiapoptotic caspase inhibitor, may lower aminotransferase activity in patients with chronic hepatitis C" published in 2007:
"A fourth and final area of concern is the risk of development of cancer with the use of a potent antiapoptotic caspase inhibitor. Because of this concern, we excluded patients from enrollment in this study if they had cirrhosis or elevation of alpha-fetoprotein levels, and we limited the duration of treatment to a 14-day dosing period. Future studies with a longer duration of treatment will require careful and long-term follow-up of patients for the development of hepatocellular carcinoma, especially those with cirrhosis due to HCV or HBV."
Well, obviously anything that inhibits programmed cell death puts someone at risk of cancer. The question then becomes one of assessing the risk versus the benefit. For an investor, the issue is then what will be required of CNAT to resolve the question. More specifically, how long will it take to resolve it and how much will it cost?
...first, Pfizer didn't "spin off" Idun -- they SOLD it back to the original owners...why?...because they couldn't find anyone else interested in taking it...
...as far as "CV event seen in mice" -- seriously?...Idun had already completed a phase TWO trial in 2005 and had started another...in 2007, an independent study dosed EIGHTY patients with idn-6556...a little late in the day to be worrying about mouse cardiovascular events, wouldn't you agree?...
...no, I doubt Pfizer feels "stupid"...I suspect they're sitting back laughing at all the FOOLS who buy into biotech HYPE....
..."Partnership deals"???...gOMER has been looking for partners for around TWENTY YEARS now and you see how many they got, right? And why? Because potential partners realize that third party reimbursers are not so stupid as pay 200-300 bucks for twenty five cents of antique generic drugs dissolved in a bag of water...and when you consider that most of Europe is socialized medicine, you can be POSITIVE that they won't either...
..."this could be a major breakthrough"?????....uhhhhhh, -- no...Kidron apparently didn't even realizehow much insulin was in each pill -- at least judging from the patent...now the company has finally admitted there are 460 international units in two pills and two pills constitutes ONE dose...the poster they presented at Yale on May 14 demonstrated clearly that 460 units of oral insulin only lowered blood sugar by about 25 mg/dl...ONE unit of SQ insulin wil lower glucose about 40-50 mg/dl...that means you need around 900 units of oral insulin to match ONE unit of SQ insulin...a type 1 diabetic uses about 30-50 units per day and would therefore require 30-50 THOUSAND units of oral insulin per day...get out your calculator and figure out how much that would cost with insulin running about 10 bucks per 100 units...
..."REAL MD"????...well, if you're a "real md" -- which I am, by the way -- exactly which part of my analysis is wrong?
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!
..."why"????...uhhhhhh, to make money, maybe?..."wasting their time"???...not if their brokers can line enough SUCKERS to buy the hype AND the stock!...
...I'm still trying to find all the "more information" from the trials ORMD did back in 2005-2007!...And Kidron?...isn't that the IDIOT who apparently doesn't know how many international units are in a milligram of insulin? ...oh, yeah, she's REAL "prominent" all right -- prominently STUPID!...just ANOTHER Israeli SCAM company...
...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!
I checked ENMD's website to find the ASCO poster for the ovarian cancer, and I read it but I swear I couldn't find any results anywhere! What was it supposed to be -- an "ad" for their clinical trial or what?
I also looked at the other poster for sarcoma and saw it reported a "clinical benefit rate" was 27%. I don't even know if that's good or bad since I consider "CBR" to be just another "dog and pony show" measurement designed specifically to make results look better than they really are. However, the "secondary objective" of overall survival was NOT reached. So what else is new, right?
Can't think of too many stocks that deserve it more! Now if it can just hurry up and get to where it belongs at ZERO, then I gratefully be able to ignore it again!
...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?...
...oh, yes, several...largest is Millipore and Pharmacell collaboration...the University of Pretoria used to have one of their own design for sale to interested entrepreneurs -- in case you're interested in going into the biotech scam business.
Sentiment: Strong Sell
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!