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I would expect a correction of the days post surgery issue.
I would not expect one on the 90%, as they used LL's statement to JAMA and LL never bothered to correct her statement,.
Not exactly big issues in the real world. The article is still going to note the lack of the published radomized OS endpoint and the overall conclusion will not change.
The best avenue is to publicly attack SNO as they are the sponsors of the the article.
Use their own journal via comments to do so.
Come on boys, have some balls.
So when asked by JAMA Oncology why the comp to 99 was not used for OS, LL said:
meirluc, the main point is that it was never presented.
As for the reason, it was LL who said to JAMA 90% of placebo had crossed over was the reason.
Are you saying it was a monumental error to accept what LL said?
The sentence was referring to the Oct PR (OK, I mistyped that). The update in the previous sentence was the Sep PR.
The idea that the "provided an update" was somehow the PR itself is absurd. It is a construct to support you read is all.
Come on flipper, parse the sentence.
Rozona, the letter by NWBO lawyers had nothing to do with transcript or even the oral arguments at all..
The defendants were attempting to submit the NWBO trading data over the alleged spooking incidents. NWBO's team wants to disallow it..Typical bickering about what should be allowed at this time is all.
The only odd thing is the disagreement by both sides wrt the the data being public.
The defendants assert:
For sure NWBO had no obligation to disclose the supporting documents issue either earlier or now.
The issue is that in the recent PR they said they had previously disclosed this fact. And that was a lie as they had not.
Regardless of what exactly they are saying on the status and going forward, was this statement a flat out lie?
So the day traders were not shorting NWBO on the 23'rd so more shares were available to borrow. Wow. Wonder why?
An no, the official semi-monthly short report is not late. FINRA is scheduled to publish it Monday. Unlike some company we know of I would expect them to deliver.
Further, over the 2 days you clearly note the shares available to short increased. And you concluded the shares shorted increased. Odd.
Yes, another paper that asserts the UCLA ATL-DC is very different from DCVax-L. And you wonder why NWBO has never says a peep about these trials being DCVax-L.
Sure.
First, you are comparing ORR in different settings which is pure nonsense.
Second, and most important. The Merk deal is for 3 specific ADC's. The additional payments are for development of those 3 drugs. This a drug specific deal, and they passed on CSF1R-1
Why did Merck NOT partner CSF1R-1 if this is supposedly such a big deal?
This is just to ironic.
When I questioned 2 years ago how they are supposedly submitting w/o a non-proprietary (generic) name it was roundly greeted with the usual response. And that included Hoffman asserting that asserting they do not need one to file.
And now it is being used as a reason for a delay.
So tell me, if this is really true, then why dd they not get this paperwork done years ago?
So NWBO chiefs can take the week off in this critical time, But longs blame contractors for doing the same.
Can't make this shit up.
The three cases are easy enough to find in the Delewrae Court case search
Just use lastname=Black, firstname=J Cofer [Defendends are listed alphabetically]
The case is 2022-0193 - SHIVA STEIN vs J. COFER BLACK, ET AL
[The other 2 will have consolidated into this one]
Alas, no detailed info without paying.
Yes, it is true.
Go to the 360 Law Webiste
The entire article is behind a paywall, but close the login screen and you read enough of it to see that the tweet was correct.
BTW, hoff
Any reason you do not post the transcript?
The only answer I can come up with is that they have good terms on a financing deal to get them through TLD on the trial.
Zero chance that this is a squeeze.
And virtually zero chance that it is a trial leak. The trial outcome is reasonably expected to be a success, so even if the news leaked it would not be big.
No, the nominal timeline is:
80 days
potential clock stop
70 days
So with no clockstop it is 150 days.
Alas, there is virtually always a clockstop. And you have no idea how long it might last, It is 60 days to start, but it lasts until issues are resolved.
Yes, I know the data you quote.
It does not discuss time from submission to approval. The document I cite does so.
Of course it is nonsense to expect a decision in a few months
The MHRA publishers the acutual approval times here. That is the full time from submission to approval and breaks out the actual MHRA decisions from the rubber stamping of EMA decision. As opposed to your continued hype of numbers that only represent a portion of the process and include rubber stamp decisions.
From the MHRA:
The slide on page 10 is all non-rubber stamp approvals in 2023 YTD. The blue solid line shows the have approved a total of 7 this year. The red bar is the average number of days for drugs approved approved that months. 2 at 225, 2 at 440, 1 at 410 and 2 at 370.
If you go to the next chart you will see the same data for submissions not relying on Orbis or Access. The 5 drugs in that category (where NWBO will be) were approved in about 380 days.
These are the actual approval stats from MHRA, not stats on portion of the process you and hoof cite.
Not that I think it matters though.
No, I do not recall that.
My recollection was that she was talking about the switch from the original primary and said something like "quite frankly we lost the control group". Then whent on to mention psPD, the dropouts and crossover.,
Maybe you could provide the source of your information.
The one quote you previously posted did not imply she was talking about OS.
She did not say or imply that.
The patients who dropped out were LTFU for the primary endpoint. She never said the same for OS.
Regardless of the technical issues, anybody who does not understand the implications of NWBO hiding this important data should not be investing in biotech.
Flipper, you are wrong on this subject.
It is common for patients to discontinue treatment which makes them a drop out and censors them for PFS and some other endpoints. That does not make them censored for OS. There is no reason to assume that just because a patient discontinues treatment they are no longer in contact with trial. Very likely they still ahve the same oncologist who is reporting OS status for the trial.
You have noticed before how many more patients are censored for PFS than OS. It is for this very reason.
Flipper,t wrt the 232 vs 99 OS debate.
A) Why is NWBO failing to disclose this? It is still a formal endpoint of the trial.
B) The "dropout" argument by you has a lot of holes.
First, dropout are not censored for OS no matter how much you want to conflate the issues. Further, there are still 8 or so censors in the 232 arm. Do I need to link the JAMA paper for you?. So at best you are suggesting a total hypothetical that the 99 arm has had it's OS reduced by finding the lost souls while the 232 did not. Now, selectively finding lost patients would not surprise me, but I doubt it would been enough to make the results anywhere near "trending well".