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Impossible to have a serious discussion of odds on acceptance being with a few weeks when there is no definition of "a few".
If a few weeks means by Dec 14, I would agree with Iron that the odds are near 0. If a few weeks means the next 10 weeks then the odds go way up.
NWBO can submit whenever they want, And if formally complete the MHRA wll accept for review (unlike the FDA that will RTF if they call BS).
That is not "winning the war". That just gets them one step closer to being told by MHRA they do not have the evidence to be approved.
Yes. Merck partnered with Illumina. And Merck partnered with Nano String. And Merck partnered with that Japanese ADC company. And on and on and on.
You can connect dots all you want. Everybody in this space is connected. But none of this says Mecrk has any interest in NWBO.
Being a sponsor in a UCLA using ATL-DC means nothing. There are over 2000 Keytruda trials going on. Most are combo trials run by others, often with Merck as a sponsor
What matters is actually being a partner. And that is just hype here.
EDIT: Why when they partnered the ADCs from Daiichi did they not also partner PLX3397?
Agreed in principal on the 80yo+ issue.
But for LG it looks clear either he is a pathological liar or he is no longer has his mental acuity as he should.
Onco, Dr. Liau is more than an SAB member. She is also the chief clinician of P3.
Hasn't anyone with direct lines to LG or DI simply asked the question? Are we on track for delivery to publishers and for November MAA filing?
They clearly said they would do so, so I’m not sure what you’re arguing here.
Just the order allowing the lawyer who asked permission to bring electronic devices.
ORDERED that the following attorney(s) are authorized to bring the Personal Electronic Device(s) and/
or the General Purpose Computing Device(s) (collectively, "Devices") listed below into the Courthouse for use in
a proceeding or trial in the action captioned:
__________________________________________________________________________________________.
ORDERED that for the device(s) checked below SDNY Courtroom WI-FI access shall be provided.
The date(s) for which such authorization is provided is (are)_______________________.
Attorney E-Mail Device(s) Courtroom WIFI
Granted
(Attach Extra Sheet If Needed)
The attorney(s) identified in this Order must present a copy of this Order when entering the
Courthouse. Bringing any authorized Device(s) into the Courthouse or its Environs constitutes a certification by
the attorney that he or she will comply in all respects with the restrictions and obligations set forth in Standing
Order M10-468, as Revised.
SO ORDERED
Until they prove me wrong I am going to assume any communication they put out is a continued attempt to induce retail FOMO so others can sell into.
Who can compete with the super intelligent being (we call him God) who has designed it in the first place? Human with advanced imaging technique just figured out how these immune cells look like. Human just found out how to trace these immune cells. Why reinventing the wheel? Why compete with God?
Ah we talked about Nwbo. Sorry..
Two different deals.
What Thermo was involved in was basically what you are thinking. Advancing cash while they decide on terms.Those closed with various deals some of which are the "contingency gain" deal that also went to others.
I agree that the expected decision to at least partially deny the MTD adds some value to these deals for future non-dillutive financings..
No way to know how much as we have no idea what the terms are.
Most likely do to some type of arrangement (license/partner) deal with a BP.
You seem confused as to what's considered pumping and what's proper management duties.
Fudster HyGro obviously hasn't read the FDA Oncology group's ECA guidelines in the 2022 Annals of Oncology journal.
Before conducting an externally controlled trial, sponsors should develop a statistical analysis plan that prespecifies analyses of interest, such as analyses of primary and secondary endpoints, calculations of statistical power and sample size, and plans to control the chance of erroneous conclusions (e.g., to control the overall type I error probability). The statistical analysis plan should be submitted along with the protocol to the relevant review division before initiation of enrollment in the clinical trial for the experimental treatment.
Sponsors should finalize a study protocol before initiating the externally controlled trial, including selection of the external control arm and analytic approach, rather than selecting an external control arm after the completion of a single-arm trial
Careful planning in the design phase before study initiation along with the implementation of a detailed protocol can ensure comparability of patient populations and data, such that the planned statistical analyses that adjust for residual biases can be reasonably relied on for better estimation of treatment effect in isolation.
To date, no primary efficacy analysis of a study used to support approval of a marketing application in oncology has included a formal comparison to an external control arm.
No, I mean the lawsuit,
Whenever LP feels like it.
If a company is not on a Nationa Exchange there is basically no enforcement of any regulation of corporate charters on this.l NWBO last skipped a calendar year around 2017 and a financial year around 2019.
But LP likes to hold the meeting over the X-Max holidays. So that late Dec is a decent bet.
It is selling some percent stake in trial winnings.
It really does bring in non-dlllutive cash (as opposed to the loans that are constantly being paid off in shares).
Agree completely And I actually think it is a smart move by LP.
insidernews What is the authorized share amount as of today? TIA
200 patients were treated with DCVax-L in three months.
The convert loan is very kool.
A loan at 11%% is reasonable. But to get that NWBO gave the lender 2 extra features.
They can take payment at any time in stock at a price of $.40 to $.50.
They can take payment at any time in the mystery "gain contingency".
The convert option in itself is extreme. Usually converts have the covert price set above the stock price, not well below it.
The "gain contingency" is unknown. But I would bet money that they are selling off right to proceeds from the trial.
Terms would be interesting, and probably should be public.
But hell, if longs do not care why Specials revenue foes to Advent, why should they care about terms of these "gain contingencies" that can be selling off anything/.
The never said the work the contractors plan to finish is all of the application. Read the Sep PR a little more carefully.
The sections that are not "key" may well be minor. Still have to be done.
You do know there are many employees currently working for Advent Bio. Is NWBO the sole client?
Well, $406K revenue is a solid sequential uptick.
How many patients is that? Anybody know?
Don't expect to see anything new in the 10Q. That's pretty much limited to what happened during the quarter.
But did you notice September & October’s #s are conveniently adsent?
Re: FTDs
Open FTDs (all US markets) as of OCT 14 were $375,529,155.94
That is chump change in a market that size.
The FTD numbers from the SEC are available here
One thing that many of the posters making claims about how large they are get wrong is that the number is not the new FTDs that day, they are the current open position.
Many just add the numbers for the entire half month and say that is the total.
For example, if you look at the NWBO FTDs in H1 Aug they would claim about 650k FTDs as if there are that many new "counterfiet shorts" being opened. In relity there was never more than 200K, and most closed within days.
The total open FTD position on NWBO on Aug 14 was only 136K. And on many days that month it was 0. That is the open position being presented as huge.
And these numbers include all shares that have not been delivered to DTC, regardless of "legal" or not. And DTC has zero reason to not disclose these, It is DTC that would be liable f the failing selling failed.
Your certainty that the original (main, nonsurrogate) secondary endpoint has failed is far from certain.
Actually 2015 was the year the trial was stopped because enrollment had been done to the point statistically necessary according to Fraunhofer
Pattyloco, LC was joking.The Publisher has long since been hired.
For a reality based timeline per NWBO see Flipper's post.
That still assumes NWBO does not punt of course.
OK, so with the update you now assert 10-Q and MAA submission are within the next week while dismissal of MTD is not is unlikely but possible.
Let us be clear, the respected long (as acknowledged by said respected long) is asserting MAA submission within the next week.
How much should the PPS rise with submission expected within a week? What happens if it does not happen?
Maybe flipper can chirp in and divert again from the core issue to try to bail out one of his fellow longs.
Jeeze, the statement by DD was "within the next week". I agreed with that for the 10Q.
If you want to argue semantics that, fine. Most people think getting it done in the next day or two is within the next week.
Can you read?
I posted that the 10Q most likely will happen within the window DD said.I then clarified likely this week.
I called BS on the submission and MTD decision coming in the next week.
Is that factual that the submission happening this week?
That's tame. It's a valid point that NWBO received PIM in Sept and still has not been approved for EAM yet Keytruda received PIM in Oct and is approved first.
Thats huge.
If they are filing as large accelerated filer, Thursday would be the 10Q, doubt there is a leak. I think there will be three or four trading days of FOMO leading up to judge ruling on MTD, 10Q release, and PR sharing that last module went to publisher. All of that can happen by mid-next week.
FYI - Fidelity currently at 19.5%