hairball, more astonishing silliness..another dog and pony show to the same group of no nothings that will generate nothing of value to shareholders...like i advised Jenny's on the Block earlier this week, she needs to move her dog & pony show to China..billionaire chinee are dieing to get $$'s out of China..in fact earlier today chinee made offer to buy Chicago Stock Exchange..and one baby bio i own got chinee to pay double the going rate for $40M and all had to do was partner in china.. Jenny's on the Block needs to go east
more silly samisms, P3 interim will not provide a legit shot at anything other than "it's safe" given Jenny's on the Block stated interim timeline...achieving stable OS takes in general much longer than a stable PFS, now in many instances you need OS to show true benefit as often with near therapies PFS can be very similar...BUT and this is the BIG BUTT BERTHA of this story, these is no SoC for OM.. for instance (and this is nothing related to this trial) you could have usable (ie stat sig) PFS after say 8 months but it may take 12 months to achieve stat sig OS..so why wait 33% longer to get to the same output....it is nutty and goofy..
now if this goofy P3 reached full "a" portion enrollment by Aug of this year and interim was on dec 31 2017 then you could get stat sig but that ain't gonna happen
silly sam, i am verbalizing only what the collapse in share price is telling Jenny's on the Block and the BoDumskulls..her "gold standard" is unfundable and always has been unfundable that is why the share price has been in continuous collapse..no one with half a brain will "risk" $30M to DCTH..she seems to be tone deaf..and as bad i wouldn't be surprised if worse than worse DCTH tries to do a half-funding desperation before delisting...the market is telling DCTH in very strong terms what it thinks of their plan and competence
and Jenny's on the Block, when you became CEO the BoDumskulls touted and pumped their strategy to increase shareholder value (which BTW is B-School mealy mouthing nothingness, how bout increase share price)...that strategy has obviously been a terrible terrible failure but you and the BoDumskulls seem not to be listening and hearing and acknowledging the market..
..you need a new strategy you should follow my advice, which BTW is from someone who has invested his own money in DCTH unlike you or the BoDumskulls
..ps even the high and mighty O&G companies are being humbled by the price of oil and are readjusting accordingly, DCTH needs to be humble and NR the delay of the goofy Gen 2 PIII trial..too much money taking too long for too little return..nice science experiment no more..run DCTH like a business with real constraints
since you became CEO of DCTH you have overseen and led an approx 90% reduction in the shareprice of DCTH...that to date brands you as a miserable failure and incompetent..
..i believe you can do better, you need to stop taking bad advice of the BoDumskulls and other incompetents..
it appears to me the market has been telling you for some time that the goofy Gen2 PIII trial is not fundable and i agree with that 100%...
..learn to live within your means, that is great advice
stop taking bad advice from BoDumskulls and other incompetents...you have CEO'ed massive destruction of shareholder wealth and consequently are a defacto failure as a CEO and will likely not be CEO material again..DCTH teeters on BK or takeunder based on your decisions and actions and those of the BoDumskulls, when will you understand that
..take some great advice, from me, and save DCTH and your career
silly sam, too funny, now when Jenny's on the Block tells your $4 to $5 M/Q is that the "all in figure" or the mealy mouthed portion of the total figure (ie most likely excluding trial costs which can overwhelm small baby biotechs)
..too funny, after me telling DCTH to go to China for funding, Jenny's on the Block NR's heading to more useless NYC and US based dog and pony shows...have these shows ever generated any real sustainable value for DCTH i say no..stop the madness Jenny's on the Block, head to China, big money is fleeing the commie gov't crackdown go get some, man up
silly sam finally posted something agreeable: "I think $6 million is cheap enough for this technology."..the issue is i know how DCTH should proceed to increase the share price and you don't...the Gen 2 PIII trial design is goofy, doomed for failure and consequently unfundable...it is that simple and complicated..a DCTH NR stating it is shelving that folly will increased share price by 100% or more very quickly
but why did pazdur want to kill DCTH ??? IMO he was out to destroy Hobbo for the bait and switch on Gen 1 vs. Gen2...that was like trialing with one chemo and trying to get another approved...Hobbo was clearly in over his head but he was hired by the BoD..who is Alexander???
..also if i remember correctly Hobbo was all mumbly fumbly on the issue of deaths at AdCom wasn't he, like he was trying to hide summin
ps as best i remember the trial was kinda messy and wasn't that what the RTF id'ed
ps BMRN DMD drug candidate recently got branded a "killer" by the FDA
anyways DCTH should just #$%$ can the Gen2 PIII redo in the US, fly the rich folks over to EU and let the poor ones die and get loved ones to send videos of death to the FDA...
if sponsor has authority to submit and does FDA is obligated to review, and DCTH had authority to submit, all the FDA could do is do an RTF and once cleared up had to review..it is the sponsors job to file or not.. if data you quote is correct it speaks to risk of small trials, when you confidence interval out small samples you get wild inferences that may or may not have basis in reality but stats is a simple confidence game
silly sam, are you Hobbo's buddy??? as i remember the webcast there was much confusion whether DCTH was trying to get Gen 1 or Gen 2 approved as DCTH presented stuff on both and finally if i remember a panelist, rightly confused, sortof asked what the heck is going on are we here to approve Gen 1 or Gen 2, that is when Hobbo guffawed and ahhemed and a bad meeting went completely attack dog
silly sam, i can and i do, Hobbo didn't do the Gen 1 PIII but he pushed for the FDA CRL...he should've not gone forward and redone a PIII with Gen 2 it is that simple and complicated, as i betcha Hobbo knew of the safety failures but tried to BS the FDA (which rarely works)...most recent example BMRN tried BS on DMD and got burned by the FDA (they actually said it killed people)
silly sam, FYI as another thing you seem not to know, the FDA is bounded by various laws, basic one is the requirement for 2 well controlled PIII trials (or some similar terminology) basically meaning 2 double blinded PIII trials of sufficient size to show benefit...so the FDA would be breaking the law if they ever approved Gen 2 without testing..now the FDA also has the authority to do different but needs tremendous data backup and Gen 2 had no human testing the FDA couldn't approve...but bait and switch was a stunning tactic, never seen before and will likely never see it again
neal one thing i nor you can blame on Hobbo was the Gen 1 PIII...but i am quizzical on the safety issue, as i read the DSMB gave a thumbs up mid PIII didn't they...so what was the reason for the supposed bad safety and was it "clean" to Gen 1 or was it one of these many confounding issues that can be caused by crossover...i assume the safety issue was mostly cumulative toxicity with insufficent counter measures likely due to what lack of proper PI and PII testing??? safety tends not to raise its ugly head in most PIII's and in that regard it was almost like this was more of a PII trial regards
that speaks to a significant amount of stunning incompetence carried on even today..
..the current BoDumskulls is as incompetent as previous ones no more no less..
..by posting, whether successful or not, i am giving Jenny's on the Block the advantage of my advice and guidance..
..the goofy PIII Gen2 is unfundable and doomed to fail, someone i guess me needs to keep telling her that..
..she has choices to make to save DCTH, which is savable, but not with current goofy PIII plan...i advise her again to shelve that PIII and focus on he EU and HCC/ICC...
but i agree with the most salient part CS does shrink tumours and is commercial in the EU.. the EU may not offer as big $/treatment as US but IMO more than enough for DCTH to live off but it requires a reigned in ego..
..many studies have shown that women execs are more business and ego sensible then men, Hobbo was an egomaniac..PS IMO pazdur showed up at DCTH AdCom to personally destroy Hobbo for the nerve of trying to bait and swith Gen 1 study with Gen 2 approval... that was immensely galling and nearly criminal IMO pazdur was right to destroy him..to bad pazdur didn't separate appropriate disdain for Hobbo vs. potential benefit of Gen 2 (ie a better new PIII trial)
silly sam i only bought a starter position in DCTH as i was not comfortable with the 240 Gen 2 PIII that i read about as the Gen 1 PIII was only 95 patients and failed DCTH states due to safety not efficacy..and so why is Gen 2 +2.5 times as big with additional problem of OS as objective...it is non-sensical..i was expecting some details that indicated it was a very flexible design (akin to adaptive) but it seems a goofy full on 240 patient study ..Gen 2 interim will not be definitive for FDA, i guarantee it...IMO FDA is telling DCTH to go blow for OM
that goofy PIII will prevent DCTH from getting to $100M MC...shelve it wait on HCC/ICC interim data then decide best course of action (which unless HCC/ICC is a dud won't be the goofy PIII)..understand this IMO as Gen 2 is already OM commercial in the US, gain HCC/ICC approval DCTH will own OM space on off-label use...why waste the very limited funds DCTH could get
ps here is the other interesting tidbit, there is no evidence that i have ever seen that suggest Europeans are most at risk of AE's after approval then they are in the US...what this points to is a flawed FDA approval process caused by overeliance on stat sig defined in the era of chemo bombing..FDA actions has led to incredible suffering, which i guess is why they are being "modernized" to more of my way of thinking
silly sam you really are a know nothing aren't you..if that goofy Gen 2 PIII was economically enhancing Jenny's on the Block would've touted its cost already, and in fact i have owned other baby bios going into PIII that have given economics to public along with a value accreting financing...why hasnt' Jenny??? if it was pumpable she woulda been pumping it