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?
..." 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!
"...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.
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.
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.
...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?
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?
"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.
..."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.
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! 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!
"...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!
"...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?
"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!
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?
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.
...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?
"...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!
"...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!