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#1 has been seen as necessary to protect against attacks by AF, MRC, other parties allied against NWBO, etc.
However, if #2 happens it would not only render that moot, but also provide much needed acceptance and any protection and promotion that may still be needed. If, as speculated on this board, the likely partner at the dance is MRK, then they have been involved in some shape or another for some time - Duffy's sojourn at NWBO, Keytruda and DCVAX being used at the UCLA trial. So, presumably,some level of due diligence would have already been conducted.
In addition to the time needed for due diligence and deal negotiation, NWBO and MRK may be in discussions with FDA for rGBM (as Flipper was opining) or getting some other ducks lined up. Such discussion would certainly affect the deal parameters, especially the $$. For example, if FDA indicates a favorable tilt for rGBM pursuant to certain conditions being met, it increases the value of NWBO. These discussions could add to the uncertainty in the length of the delay.
All told, IMO, looks like #2 is a strong candidate for the delay.
I seem to recall a poster named TCTRADER. Wonder if TC is the same individual and tweets under that handle?
After twiddling around in the 1.36 - 1.40 range for a day and a half, that move up was quick.
The NWBO chart on CNBC (https://www.cnbc.com/quotes/?symbol=NWBO) show a steady stream of '200' transactions. Is this of any significance?
I think they are cheekily echoing back speculation on this board of TLD next week and a BO by MRK (NASDAQ).
A bunch of NWBO shorts led by a previous IHUB poster who went from being very bullish to an extreme bear - Steven Guardino. Some say he soured on NWBO, others have speculated he was enticed to the dark side.
Already at $1.45
iwasadiver - Much respect to you and all those on the frontlines. I have a family member in the medical profession and so get a glimpse now and then, even though he prefers to not talk about his experiences.
Kabunushi, I believe you are referring to the Carried Interest loophole.
https://www.investopedia.com/articles/investing/102515/carried-interest-loophole-americas-tax-code.asp
Definitely sounds like a gimme to the hedge fund and investment management sector.
Being cooked Texas style - slowly on indirect heat. Takes a while, but tastes great once it is done.
He is supposed to have said "few" and not "several". Few is three and so that could be the week of December 7. Just saying...not predicting.
Since the trend has been to drift lower everyday, there would need to be some catalyst to cause a reversal. Don't foresee anything out of NWBO this week to cause that.
I agree with that and probably the sooner the better (at least for us shareholders). I was just avoiding hazarding a guess about a time frame, given all the uncertainties and unknowns about all that could be going on behind the scenes and NWBO track record.
If MRK is involved, then very probably nothing this week, since they have already announced an acquisition this morning. After that, is anyone's guess.
So, using this model, MRK could do a deal for DCVAX-L and NWBO could spin off DIRECT into a new company with MRK investing in it as well.
Looks as if someone didn't like how Evanstony's post had a calming influence on all the speculation and decided to stir the pot this afternoon with the old - what do you have to fear if you are innocent - argument.
So, perhaps the real target of LP's ire are the Pharma companies and not the shorts?
Good one. LOL.
Could NWBO 'sell' or exclusively license DCVAX-L to a BP such as MRK or BMY and keep going as a company to develop Direct. The funds from the sale or license of DCVAX-L would be more than enough for trials of Direct. That deal would also increase the SP, giving NWBO the opportunity to uplist. NWBO and its shareholders can then also get value for Direct down the road.
Just wondering.
Agreed. Those speculations of TLD by Monday or soon thereafter could come to fruition.
Is this what LP and NWBO have been waiting for and DI said that government works slow? Now that precedence has been set, they can proceed with TLD using their revised end points and the shorts, like MRC, cannot say that "FDA does not allow it and will be laughed out of the room by the regulators".
Not a bad place to be with 30 inches of snow outside.
I'll can go with that. Ex Twin Cities, Plymouth, resident here.
I hope it SNOs like the back-to-back 1991 (or was it 1990?) Halloween and Thanksgiving blizzards that dumped over 30+ inches each.
How about Austin?
But similar to DCVAXL and an immunotherapy, early stage ALS subgroup presented better results when treated with BCLI's NurOwn. Quite possible that FDA discussions are focusing on that subgroup as well.
The SP may very well recover somewhat after the market digests the possibilities of the data readout in terms of future pathways.
I believe BCLI will file for approval for that subgroup. This does happen with trials that do not meet endpounts for the full population of trial patients, but show efficacy firspecific intent to treat patienf subgroups.
Looks like 1352 is the new #13 - do not let it run.
Hopefully preceded by a top line data PR, announcing endpoints have been met, before that presentation. The price should rise dramatically if that is the readout.
Agree and known information from unblinded data points to that number being greater than 45.
Have those two announced any developments that would require Cognate to make such a big investment?
Doe the fact that this patent was initially denied and that is now being appealed have any bearing on its applicability or longevity?
Hope you are right about next Thursday. There seems to be visible equivocation amongst Congressional Republicans about using the 12 Amendment and get Republican state legislatures to appoint and direct their own electirs to vote a certain way. Sure to get to the SC, but drags this out ad nauseam.
The calm before the storm?
BSB,
Is that you behind the newspaper?
In terms that people may understand, Pfize'rs development of the vaccine was like a self funded campaign - no guarantee of a payoff until they won, aka git approval and had the ability to manufacture. Unlike a lower risk campaign undertaken by other candidates, funded by donor money.
Worth noting that, I believe, Pfizer did not participate in Operation Warp Speed and partnered with a German group.
If one party in a combo doesn't want to play ball, then what value is the combo? Or in other words it takes two to tango.
AF is going to fall flat on his face so hard that he will be unrecognizable.
Karlchen, I believe you and I are at the same point in our thinking.
I believe that DCVAX-L works and this belief is based on the gold standard of OS for immuno oncology and the 3 and 5 year survival rates based on blinded data that have bee discussed.
I believe that NWBO's quandary is that they can only show clear success if they can report TLD using the revised endpoints (accepted by UK, PEI and EMA); but may be constrained in doing that until fully cleared by FDA. Dr. Liau is pushing for the new end points, per her talk on Friday and NWBO is committed to the new endpoints, because the old endpoints do not let them declare unequivocal success. With the old endpoints, they have a clear success with their secondary of OS, but perhaps a murkier picture with the primary of PFS and thus being denied the home run that they know they have achieved. [Parenthetically, I now believe the rumored trial failure in 2015 based on a supposed interim analysis that was denied by the head of their DMC as having being conducted at all, was probably based on an anticipated murky PFS due to cross over confoundment and incompletely understood or mistaken pseudo progressions. New techniques and knowledge gained since then have led to the revised endpoints.] Absence of a clear cut success on the primary endpoint would again bring up the same debates and attacks and hence the need to wait.
The statisticians are probably proceeding on the basis of the new endpoints and hence the statements by Dr. Liau and the company to that effect. But I suspect that the unblinding and TLD will be held up until this change is cleared with the FDA.
NWBO could take a chance and release results based on the new endpoints. The FDA may not like that. But if the OS results end up being what we all believe they will be, then any ADCOMM will recommend approval and the FDA will then need to make a decision to accept the ADCOMM recommendation or reject it. I believe they will accept it.
The potential problem for NWBO could be the turmoil that will exist while this plays out and the impacts on potential partnership /acquisition discussions. A clear win out of the gate, makes all that smooth sailing.
JMHO.
Thanks for the reply Senti.