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Riddle me this bear.
NWBO is still preparing for inspections. What do you think a timeframe is for those inspections (across 2 continents) to happen? How long to evaluate the results and put together a formal analysis?
Regardless, 2 questions for the field.
1) I take from the document iron mike posted that the clock starts on the day that the (subsequently validated) application was submitted. That is why NWBO noted that the application was not changed from Dec. They are saying the clock started then. Agreed or not?
2) Does anybody have any real clue wtf NWBO is talking about wrt the validation being passed and then later confirmed? That would be a decent Q for DI (or the ASM) as whatever they are saying has been disclosed so no problem of reg FD,.
So much for that 1.7B cap.
The number of legally committed shares (warrants, options, converts, Cs + common) was 1.702B at end of Q1. It subsequently has increased another 7M.
Nobody really thought that 1.7B number would bother a CEO who does not believe shareholders should be allowed to vote?
Inflation!
The payments to Advent for Specials mfg have gone up a good bit. $1.7M in London and $2.7M in Sawston.
A total of $4.4M to manufacture for a program that generated under $300K revenue.
One tidbit we will see is if NWBO is still paying Advent $6,6M/year to manufacture Specials in London (in addition to the $8.3Ma new facility.y for mfg in Sawston).. Those numbers are just Specials, not any of the SOWs performed the last few years.,
What is the point of continuing to pay for London? Supposedly the Sawston facility is much larger. Why does LP not disclose what is going on?
Also could find out if LP has negotiated a contract with LP for commercial mfg by Advent, You would think NWBO would want this done in advance (and per the 10K, it is not), Once approved (hypothetically) Advent would have a bargaining advantage as a new facility could take a couple years to get up.
Agreed that this does not really matter as approval is not happening.,
Oh, also might see how much of that $10M is going for Advents new cleanroom and furnishings.
Zip, when generics are approved the PK/PD is evaluated by the FDA to insure they are "the same".
So the degree to which the issue exists, it has been blessed by the FDA. And that makes it a tough argument to make that the FDA is wrong.
Not saying the FDA is not wrong, just saying not an easy fight.
Sticking to the general question/issue. ...
Look at the approval history of Yervoy.
BMY grew a P1 into a 1000+ patient pivotal trial, but with some quirks that could cause issues. So they started a concurrent trial with a more normal design. When they tried for approval on the expanded P1, the FDA peeked into the P3 (still blinded) for supportive data.
Yes, one can have additional trials as backups.
BP's do this all the time. Ask Flipper about what he thinks of multiplicty on all the CI P3s
Money does matter.
Humans?
The "use GTC order to prevent shares from being loaned" concept is urban legend.
If you are borrowing from a broker (via margin) they have the right to use the collateral as they wish. You signed the same agreement that anybody with shares in a margin account did.
If you are not doing so, they can not lend your shares out (unless they ask you to).
The GTC order matters nothing in either case.
Well, UCLA is "not allowed" to call it murcidencel. So whoever does not allow that might not allow any NWBO PR on said subject.
They would hire Advent at 15% cost plus to actually deliver.
It may be the District Judge is viewed as tending to favor one side or the other on suits of this nature. If so, then one side or the other would want to keep him on the case.
Will not matter for the MTD, as either way a magistrate will write the R&R and that will effectively be the decision.
Every GBM patient died over 6 years ago.
Patients with lower grade gliomas live for decades.
Speaking of ASMs, the purpose is to allow owners to vote.
Saying the election should be scheduled when the current leaders have good news is a bit pathetic. Maybe Bidden should take the same stance and not have the Nov elections until he is up in the polls.
F;ing amazing that any long would accept LP's actions to not allow legally mandated votes by owners until she has a good story to spin.
I think calendar is correct, but it is definitely from submission of a valid MAA.
UK Human Medicens Regulations 2022
Too rich.,
You try to pump CVMs crap as saying if they are allowed to run another trial then -L must be approved.
CVM and NWBO are pees in a pod.
. Both based on a single drug that they claim to treat all cancers, and maybe other indications.
. Both with single P3 falted for futility.
. Both trials failed to show that patients randomized to drug lived longer than those randomized to placebo.
. Both hyping post hok crap that is only hypothesis forming,
So CVM is told by the FDA they need another trial. And you say that means -L must be approved.
Can't fix stupid.
2/3 UCLA
The only responsible parties are UCLA and Nature (plus their reviewers). NWBO is not involved, so skip choice 1, I find it kind of unlikely that the Nature side would be much of a holdup. So that leaves UCLA.
very reasonable that a review cycle could take some time, especially if authors are busy. This is an interim update on an ongoing P2, not exactly earth shaking news (despite what longs here think). I see no reason why all authors would drop what they are doing to respond to a review request code blue.
I also see no reason to sync with some external event. Sometimes papers are timed in conjunction with a conference presentation to avoid pre-disclosure. But with the pre-print already disclosed that looks unlikely (though I guess a possibility).
I previously thought it possible that UCLA would skip this if the final data was soon. But with the trial still ongoing, and looking like they might be still trying to reopen enrollment, the paper on the primary analysis could be years away.
Kind of sounds like that Doc hopes for -L to be available on a RTT type basis while efficacy is proved.
Oops, yes I can.
The record clearly states separate injections.
Even if they are interested in a fixed dose combination formulation, they did not use it in the trial.
Regardless, the trial has not completed with less than half the stimated patients enrolled. Almost no GBMs on the combo. And not even DCVax-L.
They are required by law to update every year even if n change has been made.
The fact that they did not change the estimated completion (of the ATL-DC Keytruda combo trial) means little as you can see from the poly-ICLC combo trial where the primary completion was updated a few days ago to be next Jan.
That the trial is still recruiting is worthy of note,. That si a required update. As it is still recruiting, I doubt it completes this year.
The Poly-ICLC ATL-DC combo study has not even reached primary completion. The trial still asserts an estimated 60 patients, so possibly they plan to reopen enrollment. Maybe they want to use DCvax-L for the rest but cannot get it?
Does this have any relation to NWBO? Can NWBO clarify?
P.S.: It is not a formulation. The drugs are being used in combo. The term formulation implies they are mixed together as part of the single drug. Ha very important difference wrt approval. There has been no clinic trial using any such formulation, and fr from clear any future trial would, different injection sites for the 2.
Garry, even though you know I often disagree with you on issues wrt the FDA and other RAs, I do know you post honestly from your heart., Please keep posting and know that most all appreciate such posts even if we disagree on technical issue.
Already gone from X. And I suspect this thread follows in minutes.
Fair enough.
So Smitty is accusing IHUB of being negligent in allowing confidential information to be exposed.
And the guy showed as proof a screen shot of a third party website where he entered an IP number to get the location.
Sounds like a pure BS post on twitter.
And being respammed here.
Hey Smitty.
I would assume you know that the IP/user information can only come from within IHUB.
So you are accusing IHUB of privacy violations. That is a fairly serious charge against a company such as IHUB that relies of social media for profits.
Do you think your allegations of criminal activity by IHUB are justified?
More longs who think the MMs admitted guilt in the MTD.
This is a laugh. Longs whop think that should be investing in AI as they clearly lack the native version.
BTW, your post about UK making DCVax a profit center is a hoot. May start a separate thread on that one.
Hey Perk.
The whole "I said I was an IT guy" came from a post where I talked about understanding microprocessors and SOCs and how they were used in embedded systems as that is what I do for a living.
That you, Hoff, druggie and the rest are so f;'ing dumb to think this makes me an IT guy is comical.
Tool on.
Do you have any idea how many trials of DC vaccines have been run?
See this paper for a clue: The first 1000 dendritic cell vaccinees
That is old, I am sure many hundreds have been ran since then.
First, the defendants never admitted they spoofed.
As far as being a crime, if they intentionally manipulated the market by posting false asks then it is a crime. Just posting asks that do not get executed is not a crime.
On penalties, if the Court sticks with the current view that damages would be limited to a one hour time frame then they are something like $100k. If the Court goes with opinion in Phunware that damages are limited to a few seconds it is unclear if NWBO can assert any damages. If NWBO can convince the Court of long term price impairment then it could be a few million, but hard to estimate.
As far as punitive damages, probably same order of magnitude but who knows if it actually goes to trial.
EDIT: The reason why the amount even was brought up is that it goes to intent. Intent is needed, but hard to prove. One way of establishing it sufficiently to get to trial is motive and opportunity. And money goes to motive.