Problem is, you see, that SSH has hardly produced a SHRED of worthwhile reproducible evidence that the c-pulse does ANYTHING to improve cardiac output in class III CHF patients! No increase in cardiac output means no improvement in CHF. It would be EASY enough to measure, so why don't they do it?
...uhhhh, yeah! And didn't Mills ORIGINALLY recommend SSH three YEARS ago with a price objective of $12.50? And didn't MILLs just recently CUT his most recent price objective?
And don't you love the way he says "we WOULD be" buyers? But of course, they're NOT! In fact, they're probably sitting on inventory they'd just LOVE to get rid of to some NAIVE investors!
You want to see something hilarious? Look up "Gigadynamics" -- another podunk Australian company wanting to hop on the NASDAQ gravy train. On March 5th they TOO had to suspend "enrollment" because four out of the 325 patients "enrolled" got liver abcesses. NOT 4 out of the number of patients that got the device, but 4 out of the number ENROLLED in the study.
Who does THAT remind you of? Makes me wonder if Australia offers specialized training in stock scamming.
"...had willing patients..."??? Yeahhhhhhh...because their patients were class 4 and were five feet in the grave with the ONLY thread hanging to grab hold of being an LVAD.
C-pulse is for class 3 patients and is meant ONLY to relieve SYMPTOMS of CHF. Of course, seeing a slew of patients dropping over after getting a c-pulse MIGHT make them wonder whether their symptoms are really all that bad!
"SSH is going to fabricate a story of deaths..."??? Oh, they didn't "fabricate" ANYTHING! They merely jumped on a REALLY good excuse to suspend enrollment! Of course, they didn't NEED to suspend enrollment! Just like they didn't NEED to notify the FDA of the suspension or get the FDA's permission to re-start enrollment! But, hey, it gives them a several months breathing room and a great future excuse!
"Presented data on the positive effects of C-Pulse on Left Ventricular (LV) stroke volume and wall stress demonstrating improvements in reduction of Wasted Energy and Tension Time index, key metrics in assessing myocardial oxygen consumption."
Oh, really? That's nice? WHERE? Does ANYONE recall seeing ANY of this "data" published ANYWHERE? Does anyone besides me think Rosa needs drug testing?
"Two additional implants completed in the European OPTIONS HF study in the fourth quarter at newly activated sites in Germany and Austria, bringing total EU implants performed to 12."
Oh, really? Back on January 12, they said:
"With respect to the European OPTIONS HF study, Sunshine Heart finished 2014 with 14 implants performed of which two implants were completed in the fourth quarter at newly activated sites in Germany and Austria."
Uhhhhhhh...anybody see any PROBLEM with those two statements? They HAD 14 implants two months ago, but have only TWELVE now? What happened to the other two? Did they die as well? Were the devices removed for some reason?
..."FDA restart assured"???...of course it is! They didn't NEED it to begin with! They DON'T need it NOW! They could restart this very minute and suffer no complaint forom the FDA! They didn't even NEED to stop enrollment!
You recall WRONG. The presentation clearly said they had ENROLLED 40 patients, but did NOT specify how many had actually been IMPLANTED. SSH has NEVER specified how many have ACTUALLY been IMPLANTED inthe trial. EVEN with reporting the FOUR DEATHS, the company did NOT reveal how many SURVIVORS there still are. I'm inclined to suspect that the ENTIRE experimental arm of the study may have died! Now THAT would be a good reason to suspend "enrollment"! You can't run much of a trial if your experimental arm keeps DYING on you!
"...your own appraisal..."??? Hmmmm...let's see...SSH is in the toilet and pretty darn close to getting flushed by the overall look of things. Patient need is high but for soemthing that WORKS -- NOT simply some goofy device that appears to do little more than massage the aorta.
Device related or not, the trial is seriously DAMAGED by the news of FOUR deaths. Moreover, SSH's failure to come forth with the number of SURVIVORS with c-pulse hints that perhaps the entire experimental arm died!
There is NO indication NOR is there any reason to SUSPECT that the trial will be "downsized" UNLESS SSH wants to dump the current trial and submit a whole NEW protocol for a NEW trial.
So far all SSH has been offering is smoke and mirrors. First, the enrollment issues -- need to "instruct" the cardiologists and patients, internet banner ads, spamming CHF patients' email, Reader's Digest ads etc. Then the insurance debacle -- need to close some research centers but will find new ones even though it takes 6-8 months, will re-negotiate reimbursement, will get loans to finance subjects, etc. And now c-pulse patients dying like flies in a DDT shower -- "not device related" except that they didn't die until AFTER the c-pulse was implanted!
And all that DESPITE firing the CMO and the CFO, and hiring "superstars" -- "superstars" I might add that aren't appearing real "super" about now. Of course, I guess even Superman couldn't squeeze a pile of dog manure and turn it into a diamond!
"...very good work sifting out patients..."??? Hmmmm...afraid not. Rules is rules. In clinical trials anyone who meets the inclusion criteria and doesn' meet any exclusion criteria gets selected and randomized to the control or the experimental. Note that if she HAD been able to "sift," then perhaps you wouldn't be seeing SSH suspending the trial becuase of four patient deaths.
Hmmmmm...I'm not sure how "patient has had the device implanted for four years" translates into "suggests a good deal of survival" for all the OTHER victims of the device. It would certainly HELP were SSH forthcoming about how many c-pulse SURVIVORS are still in the "pivotal" trial -- wouldn't it?
"...no stats..."??? WRONG! Read the protocol on the clinicaltrials website. For the primary efficacy measure, re-hospitization, LVAD placement, heart transplant AND death from ANY cause ALL count as adverse effects to be COUNTED when comparing to OMT. Not good to start a trial already four in the hole! HAW! Get it! Four deaths so c-pulse is now four in the hole! Too rich, huh?!
You need to read the clinicaltrials protocol for the study. Re-hospitalization, LVAD placement, heart trans plant AND death from ANY cause all count as ADVERSE results for c-pulse. With FOUR deaths to its credit, c-pulse ALREADY has "one foot in the grave." HAW! Get it! 4 deaths and c-pulse a foot in the grave! I crack myself up sometimes!
"Re-hospitalizations in Europe are ZERO..."??? Did you ever stop to think maybe that's because they all DIED before they had a CHANCE to be re-hospitalized?
And what's the ONE important fact that you DON'T know? How many SURVIVORS with c-pulse now exist in the trial? I suspect that the four patients that died represented the ENTIRE experimental arm of the study! Yeah! Better stop "enrollment," as it is we ain't got nobody to do an interim study on! HAW!
Yeah, speaking of "dumbest," I wonder how much SSH paid for that report:
"This research note has been prepared by One Equity Research, LLC. An affiliate of One Equity Research, LLC holds an ownership interest in Sunshine."
Looking at their other reports, they usually charge thousands of dollars PLUS stock PLUS warrants. I wonder how much shareholder equity was flushed down that toilet! And ain't it just AMAZING how that report came out just as insiders were selling their shares in a secondary?
"Credibility"???? Yeah right! The company fires the CMO without ever expalining why. The CEO tells everyone he expects a fully implantable device in a human by the end of 2012 when there isn't an available TETS to power it ANYWHERE in the world -- and there STILL isn't. A company that goes into a trial with inadequate funding because they THINK insurance companies will pay for it even though every medical policy statement says that experimental devices aren't covered. A company that has to close research centers it spent MONTHS to develop because they the centers won't inplant ANYONE without a guarantee of the "200,000...250,000... UNCAPPED costs" associated with each implant. A company that announces FDA "unconditional approval" for an interim study when NO such approval is NEEDED in the FIRST place. A company that SAYS its device helps hearts but NEVE provides objective data showing that the device does ANYTHING to help class CHF cardiac performance. A company that did NOT reveal how many SURVIVORS there were after the four deaths.
Oh, yeah! They are REALLY truly "credible"!
"... will go right back to ..."??? Yeah, right! So then everyone can wait for the NEXT bit of BAD news that will send it spiraling back towards ZERO! Sure! Just what every investor wants to do! Suggest you review SSH's history in Australia -- they spent TEN YEARS waiting for SSH to get "right back"! And they're STILL waiting!!
Doesn't really matter UNLESS SSH can definitively prove that whatever DID cause the deaths had NOTHING to do with the surgical procedure and/or the device. These are very sick people and it doesn't take much "stress" to cause a "crisis." The anesthesia may have caused the death but since the anesthesia is part of the implant procedure, c-pulse/SSH will necessarily be held accountable -- certainly by malpractice and shareholder lawyers.
More important are the headlines announcing suspension due the what may have been the entire experimental arm so far! Did you notice that c-pulse FAILED to mention how many SURVIVORS there are? Who wants to volunteer for "death duty"? Anyone? Anyone at all?
What I'd like to know is WHERE and WHEN did the "alleged study protocol where in the event more than three of the first twenty subjects pass away for any reason...blah, blah" come into existence! This is the first I heard of it. I sure don't see it mentioned anywhere else. No, I think this "protocol" was "spawned" as a legal ploy AFTER the c-pulse VICTIMS started dropping like flies! To the best of my knowledge this study doesn't even yet have a data monitoring committee to monitor patient safety.
Regardless, SSH shareholders better hope SSH comes up with a REALLY good explanation because I can aleady see the lawyers starting to circle overhead!