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!
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?