"...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!
"So why in all heaven would SSH want to impede..."??? Hmmmmmm...let me think...let me think! Maybe! Just MAYBE now, they have been LYING about all those optimistic enrollment numbers. After all, they NEVER have specified exactly HOW MANY c-pulses have been implanted so far in the trial. It's an open-label trial so it's not a secret. And it's the number of ACTUAL implants that matters, NOT enrollment.
All they said in the PR was that "approximately 100 patients would have been presented the option of enrolling into the study." Now, ANYONE with one eye and half sense -- which naturally excludes you -- would recognize that "presenting the option of enrolling" is a Grand Canyon LEAP away from actual enrollment, much less actual implanting of the c-pulse. In fact, it is one of the DUMBEST statements SSH has ever produced -- and they have produced a LOT.
So maybe, just MAYBE, they needed an EXCUSE to justify lower than hoped for enrollment numbers. Some c-pulse patients up and die and -- voila! -- a PERFECT excuse to shut down enrollment -- EVEN THOUGH there was NO NEED to since the deaths were NOT attributed to either the device or the trial protocol! Then comes the UNNECSSARY FDA "amendment" -- "unnecessary" because they presumably didn't alter the protocol -- which will necessarily be "approved" -- since it wasn't required in the first place -- and make for a "stock booster" press release! Talk about a "win-win" situation!
..."approval is very likely"???...that was the whole idea. Indeed, it's practically GUARANTEED since "approval" wasn't needed in the first place! UNLESS there were changes in the protocol which SSH says were NOT needed. Consequently, it looks more likejust a ploy to be able to release a "positive" PR.
"At this rate the trial will never be completed!"??? Actually I think that's kinda the whole idea! SSH is sort of adopting Muhammad Ali's "rope-a-dope" strategy -- dustracting investors with assorted delaying tactics, hoping that investors will wear get worn out and stop asking questions about what's taking so long.
Look, gravy train for brains, I don't know what mental illness you and your "alter-ego" -- "ext1414200" -- suffer from, but at least TRY and get your facts straight!
Yahoo won't allow me to hot link, but anyone curious can google "IDE Notes on Supplemental 20 Application.pdf," click on the one that says "pdf" and then read:
"WHAT IS THE DIFFERENCE BETWEEN AMENDMENT AND SUPPLEMENT?
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."
Other than timing there is NO DIFFERENCE! Which takes us back to the question as to WHY did SSH file ANYTHING with the FDA since NOTHING would be required UNLESS there were changes in the protocol. Per SSH, the protocol did NOT need changing since the deaths were not attributed to the device. So WHY did they file ANYTHING?
Oh wait, I found other problems in your commentary -- this:
"Remember that at the time of the halt about one-hundred patients were ready to be reviewed....The FDA recognizes that a large unmet need exists for class III. Furthermore the c-pulse represents a huge cost saving. Also the first fully implantable technology with the c-pulse is near and no other MCS device is even close to an FI system."
...is ALL pure nonsense!
The only problem with your assessment of the situation is that SSH has NEVER said they planned on changing the trial. They did NOT indicate in the PR that they WOULD attempt to get the trial changed in ANY fashion. Indeed, they SEEMED to imply that the trial did NOT need changing since the deaths were ALLEGEDLY not device related.
Also, as I have oft repeated, SSH does NOT need the FDA's approval to restart the trial UNLESS substantive changes are made in the protocol. They didn't even need to stop the trial unless they were planning substantive changes. Since, as I point out above, that doesn't appear to have been the case, WHY involve the FDA?
...is WHY did SSH file and amended IDE with the FDA. An amended IDE is required ONLY if the protocol is being changed in some way that might alter risk to the patient or validity of the study. Since SSH INSISTS the four deaths were NOT related to the device or its management, there should have been NO NEED to file an amended IDE.
So why do it? Playing for time? An excuse for lower enrollment? An excuse for a press release? Dave is really stupid. (I didn't put a question mark after that last sentence because it's pretty much a "given" at this point.)
Regardless, Olesen surely knows the FDA regulations -- or so I would hope -- so what's the deal with the amended IDE filing?
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!