"I don't understand why SSH accepted that number."??? I think they accepted it because the DIMWITS actually believed that third party reimbursers would pick up the costs! Well, as they say -- OOPS!
ALSO, that many patients meant that much more time for management to collect fat salaries, benefits, bonuses, and perks before having to close up shop and look for new scams to work!
"if this happens"??? Yeah, that's what SSH counts on suck...uhhhhhh...investors believing. Problem is that "this" never seems to "happen"! And right now, who cares about "interim analysis" when SSH can't even get insurance companies to pay for it and say they won't pay for it either! Kinda hard to run a trial when NO ONE is willing to pick up the tab!
"Not much volume so you can't really read into the drop."??? You know, I bet if you went and reviewed the Australian message boards during the ten years SSH traded down there after its IPO, I bet someone posted something similar MULTIPLE times as the stock proceeded to lose over NINETY FIVE PER CENT of its value.
And as far as "coulda, woulda" etc, etc -- yeah, and Tinkerbell COULD take us all to Neverland and teach us how to fly, but I really don't think I WOULD bet on it.
Wow! That was so...soooooo..."illuminating"????? And how exactly does it relate to explaining SSH's problems with insurance companies refusing to reimburse the surgery, with cardiologists ignoring it , with patients refusing it, etc, etc, etc?
Wouldn't you just LOVE a "briefer" explanation of why SSH did NOT do a SINGLE, SOLITARY implant in Germany last quarter and why they may NOT do ANY implants ANYWHERE this quarter? SOME explanation a bit less "wordy" than the article you quoted?
Actually, I suspect that the typical bagholder usually CLAIMS to have made money "trading" the stock rather than admitting they were so dimwitted as to have actually bought the thing in the first place!
Oh, gee!! NOW you figure it out! And what were you saying back in June:
"I am a REAL MD and am very optimistic about this company, its legitimacy, and its recent market run-up in anticipation of the ADA meeting beginning tomorrow in San Francisco..."
And what did you ask me back then:
"...what kind of medical doctor are you? Are you a Fellow of the American College of Anything, other than bashing companies trying their best to advance medical science? Time will tell with Oramed, but you in my opinion are insulting and pathetic."
Actually I'm a "Fellow" of the American College of People With an IQ Greater Than 90" -- which OBVIOUSLY you're NOT! Excuse me while I GLOAT:
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!!!
What a joke! First, SSH management does a major "Houston we have a problem" at their conference call by admitting that "many" centers are refusing to implant c-pulse without guaranteed compensation for whatever insurance refuses to reimburse and by admitting that, evidently, ALL insurance is refusing to reimburse.
Then they turn around and MAGNIFY the issue by putting out a press release trying to blame "audio interruptions" for a "misunderstanding" and claiming things really aren't so bad!
There were NO "audio interruptions" when Rosa said reimbursement was a problem with "MANY" centers and when he indicated that some centers will have to be replaced. There was NO "audio interruption" when Rosa whined about the time and effort spent recruiting these sites, only to have the hospitals' FINANCE DEPARTMENTS -- HIS words exactly -- refuse to accept patients without guarantee of compensation.
Then the idiots say today, "Reimbursement challenges with private insurance companies are common in clinical studies in the United States for technologies that are not commercially approved." Well, DUHHHH!!! That's because NO insurance company reimburses ANY experimental device without subjecting it to an extensive pre-approval. If those idiots had simply read ANY insurance company medical policy manual they would have known that!
All that shows is what a dumba__ the author is! The author totally ignores that it does NOT matter what the incidence of LAD STEMI are in the general population. What DOES matter are the etiologies of the patients in class III and ambulatory class IV since both devices' clinical trials are aimed at those patients. IF all of those patients have LAD infarcts as a source of their CHF, then the parachute and c-pulse are competing for the same patients.
As far as class III non-ischemic patients, what's the incidence in class III/IV? I don't know. I couldn't find any data that breaks down the frequency of various etiologies in class III/IV.
However, I DO know that if "Its target market is likely around 15% to 30% of the target market...," then you have to wonder how it is that Cardiokinetix doesn't seem to have ANY problem collecting patients for its trials if it only has access to 15-30% of the SAME class III/IV patients as SSH is drawing from. SSH, on the other hand, is stuck having to run newspaper ads, Readers Digest ads, spamming CHF patients' email, and spending who knows how much on "superstars" and "hiring incentives," etc, etc. And even then, SSH has documented only ONE c-pulse implant in the US trial since the trial started OVER a YEAR ago.
"...there is nothing to fear but Fear itself..."??? I hear Australians who bought SSH's initial IPO have rephrased it to say, "nothing to fear but fear itself AND losing the shirt off your back buying some worthless biotech stock."
"Parachute Device's potential market is very small."??? Wow! Kinda sad to discover SSH's investor relations is so STUPID, huh? After all, the parachute trial is on 580 class III AND class II patients -- and I'd say that market is pretty substantial.
Then again, how STUPID is it to ask a company that wants to sell you its stock to give an opinion of its competitors. Oh, yeah -- "When that thing is approved, they're goin' to put us out of business in no time at all! Whatever you do, DON'T buy our stock!" Uh-huh! gotcha!
Consider Cardiokinetix actually has THREE YEAR data! Complete with p-values!!! EIGHTY EIGHT patients too.
Consider the the effect on NYHA class -- baseline 2.6 (the parachute is for class 2 and 3) decreasing to 1.7 at six months and staying around that for 3 YEARS! And a p less than 0.0001 -- showoffs!
Consider the data for "repeat HF hospitalization + death." Parachute cuts that in HALF! Oh, yeah!
Best of all, consider "parachute outcomes in perspective." Almost a 60% improvement over OMT alone! 50% better than OMT plus CRT!! And even 50% better than OMT plus CRT plus ICD!!! Smokin'!!
No! Of course, parachute ain't no threat at all! Probably doesn't matter anyway since, at the rate SSH is going, by the time they get c-pulse approved, there'll probably be cure for CHF!!!
I happened to stumble over a clinical trial:
"A Pivotal Trial to Establish the Efficacy and Long-term Safety of the Parachute Implant System (PARACHUTE IV)"
Lo and behold, what do I see but Dr. Abraham's name! Is he hedging his bets? After all, the "parachute" looks like it could be a c-pulse killer. Look at all the places participating in their trial -- something like 60 altogether!
And they're looking to recruit 580 patients! I guess that's going okay too -- at least I haven't seen any newspaper or Readers Digest ads (like some companies have been known to resort to).
And it looks like it's applicable to BOTH NYHA class II and class III patients -- a much larger available customer base! And 96% treatment success, too -- 32% maintain, 54% improve! That's GOOD, isn't it? Takes only an hour and a half to put in, three days in the hospital, and doesn't require boring into someone's chest of any holes for pump lines, etc, etc. Looking BETTER all the time! And look! P-values!! REAL p-values!!! Lots and lots of p-values! "Be still, my fluttering heart!" Almost all of which look statistically significant! Impressive, huh?
I dunno, but I'd be willing to bet Dr. Abraham won't need to six minute walk any CORPSES for THAT trial -- unlike for you know who!! Maybe that's why he signed up!
At the end of the "update" about the fully implantable c-pulse -- the one Rosa said 3 YEARS ago was a year AHEAD of schedule and the one he was looking to the end of 2012 to put in a human -- it says:
"Lack of blood contact contact and non-obligatory feature make it the most likely candidate to leverage TETS in a mechanical circulatory assist device."
Huh? What exactly has blood contact and the "non-obligatory" have to do with anything about TETS? Geez, earlier they tried to argue that TETS worked fine in the Lionheart and that involved blood contact and was "obligatory," so how does NOT having those become an argument for TETS success in for c-pulse? Everyone else has tried to "leverage" TETS in LVADs with no success, what's so magical about c-pulse? Quick, quick! Look in the mirror! Look in the mirror!! That's it! Good! Just keep looking!
Funny, but I looked all over that SEC filing of the "update" and couldn't find hardly a THING about the US trial! I guess there wasn't anything worth updating for the US trial -- is that about the gist of it?
The September presentation is available on EDGAR. At one point it says:"eliminating the driveline is not a new idea." Well, DUH! It then references the Lionheart LVAD as an example of TETS success! Not only that but it REPEATS the same slide, but this time with the comment "No serious TETS complications" in bright RED! He totally ignores that TETS have MULTIPLE SIGNIFICANT problems which is why no LVADs use them!
"Where will clinical implementation of TETS technology first find traction?"
Really? Gee, Rosa, apparently YOU thought it was going to find traction THREE YEARS ago when you said you were looking forward to using it on a patient in 2012!
Anyone else smelling smoke? The implication is that SSH will be the "first" to implement TETS but WHEN seems conveniently to have been overlooked!
Oh, and look! They did two more cows!! And one of them is named "Dolly" -- how quaint! And take my breath away but what they didn't demonstrate that the c-pulse was able to augment end diastolic pressure! in a cow! A healthy cow, no less!! Well, won't the future farmers of America be thrilled to know that if they need to augment end diastolic pressure in any of their herd, they'll be able call Sunshine Heart for service!
SSH is always good for a laugh! From a 2012 interview:
"Currently, infections are common in VAD patients because the device is powered by an external battery through a cable that runs through the skin. "Drive-line infection is the number-one problem with these devices, and I think it's a bigger problem than people realize," Dr William Cohn (Texas Heart Institute, Houston) told heartwire..."
"Number one problem"??? You don't say! Hey, don't you work with Sunshine Heart? Funny but, listening to them, why, you wouldn't think it was any problem at all! Think maybe y'all need a little "tete-a-tete" to help get your stories straight?
Cardiologists? What cardiologists? They were all cardiovascular surgeons, weren't they? If Dr. Abraham had been there, I would have attended since I'd love to know how he managed to collect six minute walking data on those THREE CORPSES!
...tsk, tsk! You're not keeping up with the program. SSH has been around fifteen or so YEARS now working on c-pulse. Of course, most of that was in Australia where IPO investors subsequently got to watch 90 plus per cent of their purchase price evaporate over the next decade or so. When SSH couldn't find any more suc...uhhhhhh...investors dum...uhhhhh...fearless enough to buy stock, they grabbed their passports and hightailed to the good ol'USA! Yessir, home of P.T. Barnum who wisely said uhhhhh....hmmmm...doggone it!...what was it he said?
Maybe they were the only ones willing to let Dr. Abraham six minute walk CORPSES in their hallways. Understandable, I think, given the general effect ZOMBIES have on most people.
...the TCT conference presentation? They initially announced it on September 11, and RE-announce it five DAYS later? Maybe a little "smoke and mirrors" play in order to take everyone's mind off SSH firing its CMO and why they didn't issue a press release any explanation.
Well, I dunno...I guess that means these insiders here don't have much confidence:
PETERS WILLIAM S, MATHIESEN JEFFREY S, ROSA DAVID A, OLESON KIMBERLY, KRIDNER DEBRA,
YEARICK JIM, BASSETT KEVIN
...since they look like they've done pretty much NOTHING but SELL. In fact, has ANY insider -- besides Mr. Brown -- EVER bought any stock DIRECTLY? Every acquisition I see listed says "option award."
The last time I looked, the FDA wouldn't accept number of sites as trial data. How many c-pulses has the company actually implanted in US trial patients so far.
Perhaps more significant is the CMO's evident firing -- judging from the wording of the 8-k -- for reasons the company apparently doesn't want to reveal -- as judged from the lack of any press release explaining what happened. It's even worse if he actually resigned since, obviously, with two trials going on, you'd have to conclude he didn't see a very bright future ahead.
Then there's the latest PR about "three equity awards under Sunshine Heart's New-Hire Equity Incentive Plan."
Even aside from wondering how many of these awards are required for "incentive" -- SSH reported similar awards earlier this year for apparently the same three people --," these "new hires" aren't all that new, having been employed around six months now. These people sure seem to be needing an awful lot of "incentive."