it may not be in her nature, but i would love to see the NWBO shorts gets crushed so badly on a surprise and glorious announcement that they would be incapable of shorting another stock for years
along with that i would love to see those who loaned shares to shorts getting pounded even harder but, since they will not be harmed in any way at all, i can only wish a pox on them and much bad luck going forward
so how come shorts never bring lawsuits against a company claiming they withheld good data or whatever
after all, the potential is growing for a big surprise
"it seems some think it is possible that the events have been reached. That is not necessarily good, because the longer it takes the longer the survival rate is for Dcvax-L."
except that if 50% of the 300 enrolled are in the control group, Northwest could reach the 149 event threshold with all the vaccine patients still going strong
of course, all 300 have not been in the trials long enough for that to be a realistic scenario but it would be a fantastic result if, say, they reached the 149 threshold with 80% control group and 20% vaccine even with just the 300 and even with their average time in the trials
300 is a good number -- if it could stop an army, it can stop these piddling short attacks
okay, i got a carried away because you suggested, "the IA was reviewed months ago (when NWBO went quiet)," and the discussion was revolving around the latest 8-k which informed us that regulatory compliance papers (of some sort) were being filed
i should have paid more attention to the rest of what you said in the same post, "In parallel, NWBO is preparing the BLA based on the IA data, to be submitted by end of year, and will be requesting priority review."
my opinion is that "by end of year" includes this month and early October if, in fact, the interim analysis has been completed
well, i expressed this 3 times under your calculations in that message yesterday and each one got deleted after about 20 minutes, so i just deleted my original post which deleted your calculations -- sorry about that, but now you see why i was confused
immunonc posted another one today suggesting that screening may have been stopped because they already have enough potential enrollees AND that Linda may have already filed for approval based on interim analysis results AND the rest of the enrollment will be to fulfill commitments made to hospitals and the patients will all be receiving vaccine -- all of which is beginning to sound reasonable
i thought when the trial was enlarged that the new interim analysis mark was 248 events but others (including senti) are saying that is wrong -- if it is just 149 then there is an excellent chance it has been reached and we could be off to the races very soon
concerning the temporary halt in screening, immononc has made an intriguing suggestion, namely -- that the IA has been done, papers are being filed, and Northwest has already screened enough patients for full enrollment in the event the trial even has to continue
thought Zachs had this right...
"The original trial plan involves enrollment of 312 total patients in the trial, and counting 110 “events” of tumor recurrence or patient deaths from among these 312 patients to determine whether the primary endpoint of the trial is met.
NWBO has modified its trial plan so that it will enroll 348 total patients, and will count 248 “events” from among these 348 total patients to determine whether the primary endpoint of the trial is met. So, the number of “events” counted in the statistical analysis will increase from 110 to 248, but the total enrollment in the trial will only increase from 312 to 348."
maybe then they will bring a class action lawsuit against Linda for not disclosing positive information
really, how come shorts never bring lawsuits against a company when a stock goes up
you might be guessing correctly
but it seems that if she gets confirmaion from the DMC that an interim analysis has been done, she is required to make that public
of course, the SEC just allowed Buffett to quietly accumulate a big chunk of phillips 66 stock without following filing requirements
it just does not seem likely that we have reached 248 events, let alone reached that trigger and had enough time for an interim analysis to be done
the latest PR says 300 are enrolled, but some of them have not been in the trial for very long and it takes time before patients reach an event
it just is not plausible to have reached 248 events already but, if they have, then an 8-k is required and that is why it is premature to suggest screening has been halted because Northwest is filing for accelerated approval
"For those who may not agree - tell me one other company right now that has an upcoming interim read out on a 300+ patient, pivotal phase 3 trial in oncology, investigating a completely new platform to stimulate the adaptive immune system, using science backed by a nobel prize winner, with the potential to put chemotherapy and radiation into 2nd and 3rd place for the first time in decades, and has the future potential to be used for almost all operable solid tumors...and the MC is a measly 500-600 mil...BP has spent more in one quarter just sifting through targets in the lab
...and the stock has retraced more than 35% from is highs, with an upcoming world wide conference of the very topic of cancer vaccines, of which it is the lead sponsor...hmmmmm
...oh yeah - and they already shared promising efficacy data from patients too sick to be included, and the most common AE is flu like symptoms."
have to be on fumes unless Linda prepaid hospitals doing these trials, and Cognate is going unpaid again
think Linda is waiting on some really good news that will make the financing much easier
thought $70 million would be the number this go around, but could well go up to $110 million if Linda gets her news and the price is right
trial can be stopped at any time for futility, safety, or efficacy but rarely has that occurred for efficacy
NWBO does have a pre-planned point for an interim analysis, and that is when 248 events have been reached
the results released in June were not from the phase III for the L vaccine, all of which results remain blinded
the interim analysis for the L vaccine phase III trials will be done when they have reached 248 events -- they have only enrolled 300 patients according to the latest press release
suspect the individuals wanted the shares in their names so they would qualify for long term capital gains after April 2016 by which time they believe FDA approval will have set off the fireworks
market cap of $1.2 - 1.5 billion based on:
-- final results from phase I
-- full enrollment in phase III
-- resolution of HE reimbursement
-- no collaboration with big pharma
if there were a stop for efficacy or a collaboration with big pharma, those estimates would triple for the former and double for the latter
they are just repeating claims that were made last year
there was no truth to them, and there have been no new claims