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?
"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?
"...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.
...investing shareholder equity in rabbits' feet than in "superstars"! Man! As if it ain't enough to have a lobotomized baboon for a CEO, this company must be cursed! Seriously, only a couple of days ago, a seekingalpha pumper writes article about "silver lining in the black cloud" of SSH, only two weeks after getting some financing that DEPENDED on enrollment, and what does SSH do on the SAME DAY that it was SUPPOSED to present at a Cowen health conference, but up and CANCEL the presentation because they find out that that they have to suspend the trial because all their implanted patients are DYING!!!
I tell'ya, somewhere there MUST be some SSH voodoo dolls with a LOT of needles sticking in them!
"...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.
"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?
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?
Pray tell, what EXACTLY makes you believe that the FDA's approval for an interim anlysis was required? I know of NO such requirement for a company to do an interim analysis. For example, last year BDSI did an IA on its own and even acted on the result -- adding 80 patients -- apparently without asking the FDA for ANY kind of "approval."
Indeed, nowadays MOST companies include plans for a DMC and an IA in their protocol. Of course, THOSE are companies that have INTELLIGENT managements.
No, I think the "FDA approval" was just par for the SSH "smoke and mirrors" course.
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?
"...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?!
"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!
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?
"...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!
..."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!
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!
Look at it this way, you're planning on surgery by some doctor one morning, but read a news report that he's being investigated by some government agency for having an unusually high number of patients dying on his operating table. Are you going to have second thoughts? Think maybe you MIGHT wanna hold off just for a little bit? Maybe just forget THAT surgeon altogether?
...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.