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So, could the $3 million GFD be from one of the smaller defendants to cover their naked short shares? It would be a securities-related transaction as described in the 10-Q, with terms still being hashed out.
I am intrigued by the fact that Flipper has posted about Marnix Bosch's June 3 talk multiple times and a few times on a standalone basis, i.e. not in response to another post. I haven't seen Flipper do that before.
Just an observation.
AF destroying another innovative biotech that I have an interest in.
Thanks. Now, I remember that one.
What is your guess on who filed the complaint? Many of us on this board have our opinions on that. Robotdroid and I think it is AF.
I see the groundwork being laid for the new drumbeat post-MAA/BLA submission.
Agree. Just the type of malicious and negative news he manufactures to manipulate or provide cover for his paymasters.
Wasn't May 3 the deadline for submitting an MAA for an end-of-July CHM meeting? So, could anticipation of that happening or someone knowing it has happened be causing this spike today?
That deference may not be for very long:
https://www.washingtontimes.com/news/2023/may/1/supreme-court-takes-case-review-agency-deference-p/
Crickets don't mean nothing is happening.
Data was locked.
TLD was released.
The Journal paper was published (and not in the Ladies Home journal).
PIP was approved.
A commercial manufacturing license has been obtained.
All things you said wouldn't happen because...crickets.
I think those crickets have been as busy as the proverbial ants, just not singing to keep you happy.
And now FDA has draft guidance on the use of ECA for trials. Of course, for you, that has no significance for NWBO.
He has his deal from tbe acquisition, he has likely fulfilled his commitments, completed his knowledge transfer, is probably available on a consulting basis and so is off to newer ventures.
IMO, Merck, and NWBO are locked in a game of chicken. They both know that Merck needs DCVAX-L but Merck does not want to accept LP's price or deal structure. I wouldn't be surprised if they are also involved in NWBO manipulation to force LP to meet their terms. Discovery in the lawsuit could reveal any such involvement if it exists. If so, the suit could get settled if the MTD is dismissed as it looks quite likely, and the matter goes to discovery.
No doubt they do. But the key question is: will they do something/anything with it?
Hopefully so. Since NWBO obviously are aware of pending medical and regulatory developments, I believe that several delays we have seen have been in anticipation of those changes being published or publicized - the WHO's definition of GBM, the Pazdur paper on ECAs, etc., come to mind. So, while the delays are really frustrating, especially because of the company's prolonged silence and some are quite likely caused by unanticipated events, missteps, or requirements, sooner or later the reason for the delay shows up.
...you couldn't distinguish between the generic name and the brand name.
if treatment patients do worse that all patients, they did worse than placebo comparator patients.
Where have I heard this song before? Oh yes: they will not release TD because the trial failed, they will never get published in a top-tier journal, etc., etc., etc. So once NWBO announces the submission of an MAA, the song will be that it will not get approved. I recall Ex posting that they will not submit a BLA because the FDA will laugh them out the door.
They tried to get approved based on a P2 that failed the primary endpoint of PFS but was stat sig on the secondary endpoint of OS. The FDA said that is no good and they needed a real P3 trial that properly defined the prospective OS endpoint in advance.
I was thinking of that dilemma that you pointed out. They will also fight an injunction because complying will show that they were spoofing - the original dilemma. So, I believe the defendants will continue to spoof, even if it means defying an injunction, and hope to bluster, bluff, and deflect their way out of this lawsuit.
Between the 20+ hours per day of electrical impulses from the helmet and now implantable ultrasound - one would end up scrambling their brain. Compare that to a kinder & gentler therapy like DCVAX-L with better outcomes.
Lykiri, Dr. Bala: Thanks for your responses and clarifications.
In retrospect, my comment was actually based on her signing onto Matt Williams's comment on the JAMA Oncology paper. To me, the original comment and Williams' response to Richard Williams were definitely negative toward DCVAX-L trial results. If so, wouldn't that be Dr. Susan Short's position as well?
So. Dr. Short is a Novocure proponent. I assume then that she would not be speaking in favor of DCVax. To the extent that the president of EANO has any sway with KOLs and regulators, wouldn't that be another hurdle for approval in the UK?
Did the Mulholland/Liau comment come before MRK?
I thought that the vaccine was re-made for recurrent patients. I assume it would have to be for those who crossed over as they would not have an initial vaccine.
Last year the insult was 'article would maybe get published in the Ladies Home Journal'. Now it is zoning approvals. Fighting a rear-guard action here as you retreat.
May flowers after April rains?
Many thanks.
Beartrap, I do nit recall a post from Thermo about April showers. Do you have that handy? Thanks.
Or Northwest's SP will be heading North?
Yeah, but the blooms are reputed to appear in May.
According to you, since they were randomized to a placebo, any benefit from being treated with the investigational drug does not accrue to that drug but is a placebo effect? Wow. What a way to get your cake and eat it too.
At the beginning of this trial, they could only be randomized into one arm or the other. So, the fact that they were randomized into the placebo arm only holds unless there is a change in treatment. I am pretty sure that RAs consider the patient's results to be in the placebo arm only if they stay with the placebo. If for some reason they enter into any treatment after recurrence, any impacts, after recurrence, would be attributed to that treatment and not the placebo. Hence, the number of initial placebo patients that chose DCVAX-L after recurrence became the rGBM arm.
A rolling submission would fit the bill - as that means they are engaged with MHRA in submitting an MAA, but have not completed the submission - hence no submission PR, something whichNWBO said they would issue upon submission of the MAA.
Could NWBO be folded into Advent and become a UK company? After all, Toucan holds an interest in Advent and LP could hold a high-level decision-making position at the expanded Advent.
I think that since Citadel has invoked Fockstein, his destruction is built-in now - either as a sacrificial "lamb" by Citadel or as an enemy combatant by Linda P.
So, what does the MHRA define as "in process of submitting an MAA"? Most people would interpret preparing an application & having discussions with the MHRA while preparing the said application as "in process of submitting an MAA".
On the flip side (the B side of the record?): Manipulators pay ghost writers to put out FUD posts.
See how that works?
FM - now that NWBio's situation has the attention of these influential politicians, do your sources believe that those efforts will cease?
Only one of Flipper's flippers.
Unfortunately, those who read his output act on it without questioning anything. And they currently happen to hold our SP almost in a vise.