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There is a big difference between "Citadel is testing/ floating..." and "The idea was floated on the IHub board today" by some iHubber
Citadel is also testing / floating $100 million settlements offers
Lykiri, what do you make of LL's remarks after the 14 min mark on the video?
Thanks for the great summary.
That is not quite right. The language is not a general prohibition for off label use, but it does give the FDA the right to institute such prohibitions in specific circumstance where the FDA feels appropriate.
When I posted I foresaw your arguments, most of which are reasonable, but still....
I certainly do not suggest pestering anyone to become an advertising vehicle for DCVAX. You are correct that they clearly do not wish to fight it anymore. And as you say, L requires surgery - of the brain if they are to tackle the brain metastases. The vehicle that can be used is Direct without any surgery necessary to the liver as you suggest and perhaps using L as well - not in the brain - but in some other cancer nodule that is easily accessible elsewhere with some very minor surgery that he could tolerate. It could actually add quality time for him to be with his family. But I would certainly not PESTER him about this. But I hope they realize that there really are no horrible side effects like with chemo etc and this could easily be done in a hospice care environment at home. If it were me, I would be happy to get such news.
President Carter at age 98 has been in the news recently for his choice of hospice care for his (liver?) cancer that has metastasized to a brain cancer. He wants to spend his remaining time with his family at home.
I have wondered to myself if his case might be helped while at home with (compassionate use) DCVAX (L or Direct or both, whichever makes more sense) that would not burden the quality of his life at home and might add months to his life? For NWBO, the risk of getting in the picture this late would be very risky if there was a highly publicized failed use of DCVAX likely to happen with a cancer so far gone and at age 98. But Imagine if Carter lived to the ripe old age of 108 using DCVAX.
That is very interesting. Has this case been appealed by the FDA? I do not imagine they will just let this go. Will the "secret sauce" used in maturing the DCs to make DCVAX be construed as "changing" the cell before reintroduction to the body?
Ex, I do not think this proves it, but nonetheless, it is my understanding that the initial MAA will be for a manual process and once the automation is complete and perfected they will go for that approval.
As I responded to Ex:
Kool.
So the MIA can not be granted until the MAA is submitted (per you and flip). And the MAA can not submitted until the MIA is granted (per NWBO).
The infinite can kick.
Kool.
So the MIA can not be granted until the MAA is submitted (per you and flip). And the MAA can not submitted until the MIA is granted (per NWBO).
The infinite can kick.
Why would they know any better than the rest of us?
Basic idea from Psych 101: When something desired happens quickly or on time and as expected - it has impact. When something that is long expected and long delayed and daily anticipated in discussions on the hoped arrival - when it finally does arrive, it has greatly reduced impact as in "well it has finally arrived - what took so long."
So the longer the MIA takes to happen, the lower the impact will be. We saw much the same with the journal article, with TLD, etc. NWBO brings this on themselves with all the delays and no news or updates released to investors.
I got the same response from DI when I asked a similar question.
Sorry BB, that is to glib an answer. So if I buy shares through my broker, how do I know I am getting something real for my money? that will be similarly true of all retail investor buying on the open market. So who is paying for those FAKE shares and content even though they received nothing for their money?
ATL, you should add to your list
a) the approval by the RA of the application for the MAA and
b) discovery in the spoofing lawsuit
c) settlement in the spoofing court case.
I do recognize that most of these orders are computer generated and I did not mean to differentiate between man-made or computer generated orders. They would all be subject to this rule. I simply meant this would be an argument put forward against the rule, as if they meant to protect the little guy who made an honest mistake.
Skit I fully agree with you. Whether the delay should be 1 minute or two minutes or 30 seconds can be debated, but the rule makes sense and would help to eliminate spoofing or at least greatly reduce it.
I suspect that large interests will oppose it, using many arguments such as what if I make a typo that results in placing an order I did not mean or other such reasons to make it look like it is against the interest of investors to have such a rule.
I have an alternate suggestion that would accomplish much the same goal but still allow for the removal of orders right away (if they are not illegal spoofing). Every such order, without exception, cancelled within the minute after placement would require a filed report with the SEC or some such RA, specifying all the data on the timing and size of the cancelled order and the reason for the cancellation, with serious penalties for failure to file each such case. One or two such filings can be overlooked as par for the course, but a significant number of such filings would be an easy trail to follow for those trying spoofing cases. In any case just the thought of all the paper work required to avoid finals for not filing might itself be enough to cause spoofers to desist. But the fines must have real teeth.
everyone would prefer if a hundred billion or more entity were funding all of this development with their cash flow from legacy drugs, but those companies would not necessarily do this in the most sustainable way that would generate technologies that could very well cannibalize their current best selling drugs.
Unfortunately, I wouldn't count Citadel (et al) down for the count quite yet. This is going for their throat, and they will throw everything they have (Billion $) at this in order to protect themselves.
But I rather hope you are right - but it is far from a done deal.
Who is eligible for the program?
Participants in the CDRP pilot program must have an active commercial IND clinical program that has not yet reached the end of Phase 2, to allow the pilot to have sufficient time to have an impact on CMC readiness (e.g., 2 years from anticipated marketing application submission). However, in extenuating circumstances, requests for exceptions may be considered, where the development programs would still benefit from the pilot.
That was not me.
Can you please post a copy of the docket for those of us not on Pacer
Ex, even if there is no profit on the market action (even were that true), there still may me non-market incentive say from being payed by some big BP to do these manipulations. That would certainly be motive - even with no profit from the market action itself.
If more buy the cheap $9 shares than the shares ae it fell from $10 to $9 then you have more buys than sells but the price dropped $1.
Time will tell.
Not at all. if you look at the vote on the main point of contention for those not happy with management concerning the options to be granted they lost about 10% of the vote which amounts to something over 80,000,000 shares who voted against. This is well over the 5 mil you seem to be worried about.
We’ll have to agree to disagree on that point. BP comes in at all stages — I believe something like 90% of BP deals are pre phase 3.
I think the next 8K will be as announced at the ASM that will inform us of the actual number of votes that was cast on each of the proxy points. As I recall this would be within 4 days, so any day now.
To each, his own!
4 mill+ dumped in LPs face , nice ASM
Unless the Court also ordered confidentiality.
I do not dispute that a confidentiality agreement is likely (when they get to that point), but my point is that it would be by mutual agreement of the parties, rather than due to some requirement to keep confidential information obtained through discovery confidential unless a judge has so ordered..
I'd imagine a lot of discovery in this case will be confidential for a variety of reasons.
plus if there is a settlement there will be a confidentiality clause
Also, a common misconception is that the discovery is viewable by the general public - that is rarely the case.
are there significant differences between the submission to the FDA vs MHRA? I mean, the trial data doesn’t change. Make two copies and send to both? Or else count on Orbis participation?
I also think that UK will act as quickly as they possibly can to approve and rest of Europe will follow. US could be prompted by their speed to approve sooner rather than later. IMO
and we’re in the process of printing out the document, which is itself time-consuming, and carefully processing it for holes and errors.
It's working!
I just signed in to the ASM. It is at Gibson Dunn website. BUT, the window that pops up says it is a "Webinar" and gives the start time as 12:00 PM.
This should be an ASM not a webinar and the start time is 1:30 PM. Have they made a mistake? Is anyone else seeing what I am seeing???