From the press release:
"Finally, in terms of expanded opportunities beyond congestive heart failure, the Company has initiated a research program with Dr. Mark Slaughter and the Jewish Hospital of Louisville, Kentucky for the treatment of Pulmonary Arterial Hypertension."
Pulmonary hypertension????? For added emphasis, imagine about two feet high: "??????????"
In the the conference call, Dave IMPLIED -- you might want to sit down at this point -- that they were planning on trying to use the c-pulse to MASSAGE the pulmonary artery! Cross my heart! He said there was reason to believe that "massaging" the pulmonary artery would reduce blood pressure within it. I am NOT making this up! I'm still researching it, but at this point, it is the single DUMBEST thing I have EVER heard of!
Helpful hint -- when a biotech gets in trouble on a trial, management often starts other "programs" that don't seem to have much to do with the company's original "mission." It helps distract investors from the "trouble" and provides an excuse for future trials and secondaries. Just something to keep in mind.
Say what, Dave:
"During an interruption in C-Pulse therapy, the CardioMems device recorded hemodynamic variability and an increase in heart failure symptoms while conversely improvement in the hemodynamic and heart failure conditions were improved with the C-Pulse therapy as measure by the CardioMems system."
"Cardiomems"??? When did Cardiomems enter the picture? Cardiomems is for measuring ambulatory pulmonary artery pressure. While PAP certainly increases in CHF, the increase is due to the inability of the LEFT side of the heart to dispose of sufficient quantities of blood coming from the right side. Consequently, why not SIMPLY measure cardiac output DIRECTLY and see what c-pulse does! I swear, they can't afford to pay for the implants and follow-up care of the c-pulse trial subjects but they can afford to put PAP monitors into patients and finance PAP research?
Perhaps more relevant, what happened to the "SphygmoCor" that SH boasted about earlier this year? They evidently thought enough of it to buy some from Atcor -- a publicly traded company in AUSTRALIA! Their last earnings report boasts of the "multi-unit sale to Sunshine Heart, the C-Pulse heart assist device manufacturer for patients with moderate to severe heart failure. This transaction followed an evaluation which confirmed the considerable benefit of adding SphygmoCor to assist C-Pulse programming and patient therapy optimisation."
But I don't see any mention in the PR or conference call about it. Well, I guess it's nice to know at least some AUSTRALIAN company is making money off SSH.
Leave it to Dave:
"We are also pleased to report that there have been zero exit site infections in the study to-date."
Well, Dave, ya'know, FIRST, they have to be ALIVE to get an infection! That "alive" part has been a bit of a challenge for SSH, hasn't it?
THEN they have to have had the c-pulse in LONG enough to get an infection. So, Dave, since 90 plus percent of divelines get infected by the end of one year, all you've managed to accomplish is reveal to all the world that so far not a single patient haslikely been in the experimental arm more than a year -- DESPITE the fact that the trial has been running for over TWO years now. Way to go, Dave!
From the conference call:
QUESTION: "...on OPTIONS HF trial in Europe, 14 enrolled now, can you just talk about...that...and how it can...accelerate the pace and then any download of clinical results, anytime throughout the backend of 2015 on those European patients that we should be expecting this year?"
Dave at his best:
"Yes, so when you look at Q1, we actually lost five patients to calcium. And I don’t believe that to-date we’ve had five patients in all the trials that we’ve been working on that we have lost due to calcium. So it was kind of an odd situation we were actually expecting to post higher numbers. I think the overall sense is that Europe is starting to pick up and what’s nice is we have some new additional centers that are coming on board. So I think we just need to keep pushing things forward at the sites.
I mean we have eight implanting centers but literally 15 sites that in total that are referring. So I do expect these numbers to increase overtime but we are definitely going to be very careful especially given the U.S. experience regarding the patients that we allow them to trail. We want to make sure that they meet criteria that there is not patients that are being in essence force into the trial because there is no other options. But patients are out there and Q1 we would have quite a bit more and it is not doing for the calcium issue."
Hey! Don't look at me! But this calcium thing is NEW. FIVE patients "lost" -- aka "died" -- due to calcium? Out of what 14 patients? That's just plain weird! Certainly not the kinda stuff that would encourage c-pulse volunteers. Is SSH planning on offering some MORE DETAILED explanation?
..." hiding something imo"??? Oh, come on! How could you possibly think such a thing? I mean, management has always been so forthcoming about things! For example, take the number of research centers they had to close in the insurance debacle. Hmmmmm...no, don't count that one! Well, how about when they announced the number of c-pulses that have actually been implanted during the pivotal trial? Hmmmmm...no, better skip that one. How about the announcement back in January that they were planning on selling a big wad of stock under the ATM agreement? Hmmmmmm...no, no, better punt that one too! Wait, I got it! How about when they explained why they FIRED their "CMO" last fall -- lemme just look here --- uhhhhh, no, better write that one off.
Well, give me a few minutes! I'm bound to come up with SOMETHING they've been forthright and honest about!
Yeahhhhh...too bad "IR" didn't see fit to include an explanation in the PRESS RELEASE, huh? Then MAYBE SSH wouldn't be heading into its fourth straight DOWN day.
...yeah, and as SSH continues to draw down that ATM at lower and lower and lower stock prices, you might find that "discount" will become UNBELIEVABLY nicer! And given that SSH spends about 2 MILLION bucks a month and that the delay COULD impact those bank loans which DEPEND on enrollment, you MIGHT want to reflect on the significance of the delay in your future investment decisions.
Yes! As difficult as that is to believe, SSH HAS made an original discovery! After multiple hours of strenous exertion and dedicated research, I have determined that NEVER before in the HISTORY OF MANKIND has there EVER been a "Physician Subject Selection Committee"!
I know, I know! It's hard to believe a bunch of idiots like SSH's management could have accomplished something so ORIGINAL! But, seriously, I looked HIGH and LOW and could not find ANYWHERE so much as a SINGLE reference to ANYONE EVER using a "physician subject selection committee"!
However, given the discovery's ONLY apparent effect so far is to DELAY the trial even LONGER, I would suggest at this point only a very PROLONGED round of VERY "slow clapping"!
...that while announcing yet ANOTHER delay in the trial because of the spurious "Physician Subject Selection Committee" they proposed in the FDA supplement, they did NOT EXPLAIN exactly what this "committee" is supposed to do OR WHY it is even required.
Since the four patient deaths were determined NOT related to the c-pulse, there would have been NO NEED even to file a supplement much less get approval to resume the study. THEREFORE, what WAS the "need"? EVIDENTLY, the "need" was approval of the "Physician Subject Selection Committee." What PURPOSE would such a committee serve OTHER than to try and cull patients so as to avoid potential c-pulse FAILURES.
Does anyone have a BETTER explanation as to WHY shareholders have to wait even LONGER for the trial to resume even though the c-pulse was declared "innocent" in the patient deaths? EVERY month lost is costing shareholders TWO MILLION DOLLARS! WHY are they being forced to pay when the trial NEVER even needed suspension?
"...you would like to exclude high risk patients..."??? Well, you see, when you design a trial, you UPFRONT decide the eligibility criteria. THAT is your ONE and ONLY chance to "exclude" whatever patients you don't wish to attempt to treat. AFTER that, you are OBLIGATED to select your subjects in a RANDOM fashion from the eligible pool -- a process usually handled by a computer to insure no bias. Once the computer assigns a patient to the experimental arm or to the control arm, that is IT! You do NOT get to come in and say, "oh, I don't think I want to do THIS one, he's too high risk"! Get it? The cards are dealt and the study is STUCK playing WHATEVER hand it gets. No "takesies backsies" in clinical trials!
"...why do you expend so much energy..."??? What "energy"? With piles of dog manure like SSH, the only energy required is what I expend holding my nose while I read their PRs.
"...list a few..."??? Seriously? You need ME to find you SSH hiccups. Man, you just insulted yourself in more ways than you can imagine. Well, first was the Australian hiccup wherein the company's stock went practically straight downhill after the IPO to the tune of about 95%. Then there was the fully implantable device hiccup where Rosa said they would have one in a human by the end of 3012. That was coincident with the TETS hiccup wherein they FINALLY relaized that there was NO TETS available that owuld power a fully implantable device. There was the "walking dead" hiccup wherein Abraham claimed he was able to hallwalk three patients at the end of six months even though they were DEAD. There is the cardiac ouput hiccup wherein one researcher reported that two thirds of his patients FAILED to show any improvement in CO after c-pulse placement. There was the English patient hiccup wherein there was NO CHANGE in the patient's cardiac index after implantation of c-pulse. There was the vO2 hiccup wherein it actually WORSENED by the end of six months and wherein didn't even bother to measure it at 12 months. There was the six month hallwalking data that did NOT show a significant improvement but DID at 12 months. There's the cardiac performance hiccup wherein SSH simply refuses to even attempt to document what if ANY effect the device has on cardiac performance. Of course, everyone knows about the slow enrollment hiccup. Then you have the major fubar failing to recognize that insurance wouldn't reimburse hiccup that lead to the having to replace some centers hiccup and the need to figure out a new way to pay for the study hiccup. Can't forget the ATM hiccup...OOPS! Yahoo won't let me write any more! Hope those'll hold'ya!
"...temporary hiccup..."??? Kinda funny the number of cases of "hiccups" c-pulse has had in the FIFTEEN YEARS that people have been messing with the idiotic device! Sure hope it isn't contagious!
...uhhhhhhhh -- HELLO! It HAS been extended! Extended until the FDA reviews this idiotic "physician subject selection committee" that SSH tried to put over on them! What a joke! Given the rate at which the FDA usually decides things, you could be looking at six plus MONTHS before a decision comes back! But, hey, GREAT excuse for slow enrollment, huh?
"...announced today that the U.S. Food and Drug Administration (FDA) has reviewed the Company's submission regarding the COUNTER HF's U.S. pivotal study pause and requested minor protocol changes be submitted in order to receive approval to resume patient enrollment. The FDA did not indicate concerns regarding safety of the device and requested the updated protocol include information on several minor items, the most significant of which are the details regarding the Company's proposal to incorporate a Physician Subject Selection Committee."
Things become more clear now! I noted before that if the 4 patient deaths were unrelated to the c-pulse, then NO FDA filing or approval was necessary to restart the trial. A filing and approval would be necessary ONLY if SIGNIFICANT changes in the protocol were proposed. Obviously, if the device had nothing to do with the deaths, then no protocol change was necessary on THAT account.
HOWEVER, it looks like SSH tried to do a little "head fake" on the FDA by including a proposal for this odd "Physician Subject Selection Committee," which I have no doubt represents an effort by SSH to "cherry pick" patients who appear to have the best chance of responding to the c-pulse.
Obviously, the "fake" didn't work and the FDA is demanding more "details" on just how this "subject selection committee" is involved in "selecting" patients. Even more obviously, enrollment is STILL suspended and will be until the FDA completes its review of the protocol changes! Knowing how the FDA drags its feet, there's NO TELLING when that might be!
Moreover, presuming my assessment that SSH is trying to "cull" patients, I seriously doubt the FDA will buy it. By any interpretation of statistics and experimental design rules, such an effort constitutes a MAJOR "no-no." I hope this wasn't Olesen's idea, because she should know better.
Why isn't there some announcement from Sanofi or Mannkind? I also noticed RBC lowered their price target to 10 bucks from 13 -- seems like a strange time to do that. Are you sure your imagination isn't getting the best of you?
Geez! Are you totally illiterate or what? Did you even read or try and understand what I wrote?
SSH has said NOTHING -- got that? -- NOTHING about ANYTHING that "MUST BE MODIFIED"!!! Now read that several more times so MAYBE it'll sink through tthat evidently very THICK skull of yours. They DID NOT MODIFY ANYTHING -- okay?
The PR said, "...it will be taking a temporary pause from enrollment. This is in accordance with the study protocol where in the event more than three of the first twenty subjects pass away for any reason, including non-device related deaths."
There is NOTHING about suspending the trial to review "efficacy" or about ANYTHING needing to be "modified."
Upon notification of the suspension, SSH said,"The FDA ...has advised the Company to file an IDE supplement that discusses the reasons for the temporary study suspension and a plan for study resumption."
AGAIN, NOTHING about modifying ANYTHING.
They determined that NONE of the deaths were "device related" and one can therefore ASSUME NO CHANGES were made to the protocol. IF that was the case, THEN there was NO NEED to file ANYTHING with the FDA. There was NO NEED for the FDA to review ANYTHING. Investors are forced to wait a month to resume enrollment for NO REASON WHATSOEVER!
Well, I take that back! I have little doubt that the REAL reason for suspending enrollment was to provide a FUTURE excuse for slow enrollment.
"...using consistent wording."??? Well, God forbid that I might confuse you, but -- to me at least -- since they are the SAME thing differing only in WHEN they are submitted, I really don't worry about which label I apply.
Now, do you want to at least TRY and get back to things that MATTER:
WHY did SSH file ANYTHING with the FDA when NOTHING was REQUIRED since, ALLEGEDLY, none of the patient deaths were device related and, THEREFORE, no changes to the protocol were necessary.?
WHY was enrollment suspended when, IN FACT, NO suspension was necessary since the deaths were NOT device related? In fact, did the CEC even recommend a suspension? Or did SSH make that decision itself?
WHY are investors forced to wait a month -- conveniently enough providing a future excuse for slow enrollment -- for a response from the FDA when NO response from the FDA is required since WHATEVER they filed did NOT require filing?
"...Wrong Again..."???? Hardly! Without an experimental arm there is NOTHING to compare to the control arm -- CONSEQUENTLY, it's the number of ACTUAL implants that have been done in the experimental arm that MATTERS. For SOME reason, SSH appears VERY reluctant to reveal the ACTUAL number of implants in the experiemntal arm. For ALL you know, the four patients that died MAY have constituted the ENTIRE experiemntal arm!
"Arithmetically, the Control Arm patients are EQUAL..."??? NO! For emphasis -- repeat "NO"! NOT necessarily! Patients are RANDOMLY assigned to each group. USUALLY, a computer does that and RANDOM assignment does NOT always mean an equal number in each group -- flipping a coin 20 times does NOT guarantee 10 heads and 10 tails will result. Moreover, AFTER assignment, there is NO DEADLINE as to WHEN the c-pulse gets implanted. SSH could have 100 patients ASSIGNED to the experimental arm but not even ONE is required to get a c-pulse implanted within a certain time limit. That is WHY it is IMPORTANT to know the ACTUAL number of implants and NOT simply the enrollment.
"Just some simple elementary..."??? The ONLY thing "elementary" around here appears to be your level of education.
Try and remember to take your lithium tonight!
Look, you idiot, I ALREADY explained that there is NO DIFFERENCE between an "amendment" and a ""supplement" except:
"Amendment - An IDE amendment is any additional submissions to an IDE before approval of the IDE.
Supplement - An IDE supplement is any additional submission to an IDE after approval of the IDE."
I ALREADY explained that NEITHER one is REQUIRED by the FDA unless it involves substantial changes to the protocol.
NOW, do you want to address the question as to WHY SSH filed ANYTHING with the FDA when NOTHING was REQUIRED since, ALLEGEDLY, none of the patient deaths were device related and, THEREFORE, no changes to the protocol were necessary.?
Do you want to address WHY the enrollment was suspended when, IN FACT, NO suspension was necessary since the deaths were NOT device related?
Do you want to address WHY investors are waiting for a response from the FDA when NO response from the FDA is required since WHATEVER they filed did NOT require filing?
Oh! I just noticed what you wrote:
"The engineering theory could only have been thought off by someone with the brain of Alfred E Neuman."
Then I thought, "dang but what he ain't right! And WHO fits that description to a "T" but none other than Dave Rosa -- the CEO of SSH! You Sherlock Holmes dawg, you! Way to go!