There is no such thing as "a non-approved interim analysis." It isn't the job of the FDA to decide whether an IA is appropriate or to assist a company in designing one. The FDA does sometimes object to how companies USE the results -- e..g. Orexigen releasing IA results to promote their stock. But, no, the FDA "approval" was "unconditional" because the FDA does NOT evaluate interim analysis proposals, and therefore NEVER issues "conditions." Like I said, just "smoke and mirrors" to try and promote the stock price ahead of the secondary.
And, yes, SSH can continue whatever IA they had planned -- just like they COULD HAVE done WITHOUT bothering the FDA. Of course, NOW the problem is finding patients who either have a "death wish" or else want join the list of "martyrs" to c-pulse club.
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?
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.
...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!
Uhhhhhhh...excuse me? What are you talking about? I said:
"Seriously? So Silicon Bank DEMANDED that the new CFO unload some of her shares for...uhhhhhhhhh...what reason -- exactly? If you're going to fantasize, at least TRY to stay within the sphere of reality."
That was after YOU said:
"SEC D-Filing Was NOT A Big Deal. It Was Associated With Silicon Bank Agreement"
...which is simply nonsense! Why would the bank demand Rosa, Drayton, Olesen, Watson, and the others to sell $600,000 worth of shares? A simpler explanation is that the hogs were getting hungary and demanding someone fill up the trough! Don't want Warren Watson and those new "superstars" getting hungary now, do we?
...aren't fleeing? Shoot no! They'll stay and shake down every sucker they can find for every dime they can! Biotechs ALWAYS have the best troughs to feed at! And empty promises are guaranteed to keep that trough filled for as long as stockbrokers are willing to sell the stock!
...welllllllll...don't know if there's "bad news," but wasn't it quite the COINCIDENCE that the fluff PR about the "interim analysis" came out ALONG with a "paid pumper" recommendation from One Equity Research JUST AS the secondary offering was filed with the SEC! Geez! Have they NO shame?
Seriously? So Silicon Bank DEMANDED that the new CFO unload some of her shares for...uhhhhhhhhh...what reason -- exactly? If you're going to fantasize, at least TRY to stay within the sphere of reality.
"Imagine the anxiety and sweat these people..."??? Yeah, Dave really busted a gut to collect his well over MILLION dollar sslary, benefits, bonuses, and perks in 2013! And now shareholders get to reap the "benefits" of all his effort! Over a YEAR and a HALF into the trial before the MORON realizes that insurance companies weren't going to fund the trial for him! I can just "imagine the sweat and anxiety" of anyone who bought a year ago at11-12 dollars a share and are now watching the company flop around like a fish out of water while they sit back and calculate their 40-50% LOSSES!
And you're surprised? Can't imagine why! The fluff PR about the interim analysis which told you NOTHING about the endpoints of the analysis or how it was going to be monitored followed by a secondary offering -- seems pretty par for the biotech course to me.
I thought it was rather funny that they checked the "Decline to Disclose" box under company revenues! Guess they haven't been selling too many c-pulses over in Europe, huh?
And evidently Ms. Drayton, the new CFO, thought she better get on the gravy train quick before Dave runs it off the rails. Didn't take her long to her nose into the shareholder equity trough, did it?
Per the clinicaltrials website, negative "events" include death, LVAD placemnt, heart transplant, and hospitalization. Consider that the feasibility trial had -- by those criteria -- greater than 50% NEGATIVE events. Also consider that in the feasibility trial, the RATE of LVAD/heart transplants was something like 200-300 TIMES that usually seen in the class III CHF population in general. Not exactly numbers to make one optimistic about the chances of trial success.
"This is an events based trial. At 265 events, the trial ends."??? That's debatable. The clinicaltrials website does NOT describe it as events based. It clearly specifies a 12 month time frame for tracking data post-implant.
SSH, in ONE presentation that I could find, MENTIONED 265 events but did NOT clarify exactly what would HAPPEN at 265 events. Rosa ALLEGED in an interview that if c-pulse showed a 30% improvement versus OMT after 265 events, then it would be approved. HOWEVER, nowhere can I find SSH spelling out EXACTLY how the trial is to be decided.
Now, I have NEVER heard of an FDA trial decision being based on a specific percentage of events. Indeed, I have never heard of the FDA making a decision about a trial based on a specific number of events. EVERY trial I have EVER read -- and I've read a LOT -- required a specific number of patients in control and experimental groups that would be studied over a specified time with the data collected and then statistically analyzed for significant differences. Given the general level of incompetence that I have witnessed so far in SSH management, I have to wonder whether SSH's 265 event claim is reliable.
Absolutely correct! However, there is one leeeeeetle problem! You see, the dimwit management apparently was COUNTING ON insurance companies to pay for all the follow-up and post-implant care of the subjects! Had ANYONE bothered to read ANY of the insurance medical policy manuals they would have seen that insurance NEVER covers experimental devices.
Now the research hospitals finance departments are REFUSING to allow implants without some guarantee of reimbursement of the expected "200,000...250,000...uncapped" costs associated with each device. Insurance companies have said they WON'T! And Rosa announced at the last conference call that SSH could NOT and be successful. He said that some of the hospitals would simply have to be replaced and that SSH was TRYING to negotiate deals with the others. HOWEVER, there has been no furhter update as to how successful they've been. Rosa warned not to be too optimistic about the number of implants expected this quarter -- in other words, don't expect ANY!
So far, there are only THREE verifiable implants that have been done in the over YEAR and a HALF since the trial started. So to reach 198 you're looking at maybe another 60...70...80 or more YEARS! SSH ALLEGED that they were seeking an early review from the FDA and EXPECTED to hear something before the end of the year. Obviously, nothing has appeared so far -- probably too busy trying to figure out how to fund the "pivotal" trial!