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This is too funny,.
You do know it was LL et all who asserted the P3 was non-randomized trial. From the very top of the JAMA paper:
Phase 1B is the other 7,500 f^2 (aprox) of the facility that Advent leases.
There is plenty of extra space available in the rest of the building, agreed.
WBC's are turned over (recycled and replaced) quickly. That s why the treatments for blood cancers can work despite destroying the immune system.
In the extreme cases they use what Garry went though. They nuke the immune system so bad it would destroy the ability to recover, but then the transplant bone marrow stem cells to revive it.
One can debate if a 15% offering was a bit discount. But this was a 40% discount. $2 when the stock was over $2.8 for the last several weeks.
And for a measly $7.2M? Generally when the discounts are large they raise enough cash to live off for a year or more.
By all means most longs here probably believe he has a friend who ran "Central Research" for a BP for 30 years. yet spouts total nonsense about biotech.
But by all means, keep on believing the total nonsense BB spouts,. You are an NWBO long after all.
Either Feb 29 or March 15th, not sure which. 29th is for large accelerated files. 15th is for accelerated filers and smaller reporting companies.
I though they should have been able to file as a smaller reporting company based in the public float at end of Q2 2023. But they continued to file as a large accelerated filer for Q2 and Q3.
NWBO actually has done a decent job of reporting on time for a couple years., If they do not file a 10K by the 29th, and do not file NT-10K (notice that they are late) by the next day then they will be filing as a smaller reporting company on the 15th (unless late of course).
The photo from 10 years is stock and was not showing use in children.
I think you are confused about the fact it was detected when he was being examined for BPH (prostate enlargement) when they found the cancer.
If they just discovered prostate cancer he would be in for years of "watchful waiting" that would never have even been mentioned. Early prostate is a VERY slow growing cancer. Most all men who live a long life actually have it and nobody cares.
And there was no chance he had it for years undetected. Possible for many, but not him.
I seriously doubt it is GBM though. They are keeping quiet but they have made some vague statements thatt hint towards a less aggressive treatment plan.
Scotty obvious mean $s worth, not shares
But if you want to talk shares, no you would not 1M shares left today. For NWBO you would have about 63K shares left. For NVIDIA you would have 4M shares left.
Give Sojo a break,
He did predict 89 of the last 3 bottoms correctly.
Agreed. A single EDEN device still manufactures 1 patient's batch in about 8 days.
That the device is closed allows multiple units to be placed into a single class C clean room. That is the efficacy gain.
You are right on this one Garry.
The reason for the cassette is that it is the only part that biologically "contaminated". So after a run, it gets swapped out for a fresh one and the device is online quickly . The old cassette then goes to sterilization (or just discarded).
This was an improvement over older tech where the entire system was off-line until sterilized.
So looks like some parties unknown want to borrow shares to sell.
Any bets NWBO is running shares and "investors" are short selling into the PR hype knowing they will buy back at a discount from NWBO?
Expect the 5M or so share pop to hit in about a week or so.
Uhm, try harder.
Biosimilars, by definition, use the same manufacturing process. EDEN would change the process.
From the actual MHRA guidance
Biosimilar comparability exercise
More wonders from Zivoc (iwasadiver)
First, the EDEN process is not the same. NWBO clearly stated that the EDEN process was attempting to be close to the manual process.
Then he states they do not need a trial, only to show they make about the same DCs. Two main problems.
First, whatever metric you use for "about the same", the cells can not be manufactured w/o a clinical trial., Do you think the MHRA would accept rat data? If not, you need human patients. That makes it a clinical trial.
Second, and more important, it is not easy to say the DCs are about the same. If we knew exactly what makes some of these DCs work while others fail then sure. But we don't. There are general ability to characterize is all. That is useful to establish batch validity, but the RAs still have a highly characterized process that is the basis of any biologic.
I would assume a study to at least show a similar immune response would be needed. And maybe even clinical metrics.
Sometime next year expect to here news on that front.
You did of course see that the Prodigy unit has been approved for cellular production of an approved cellular therapy as far back as 2018?
https://www.miltenyibiotec.com/US-en/about-us/newsroom/press-releases/molmed-and-miltenyi-biotec-ema-approves-the-utilization-of-the-clinimacs-prodigy-r-equipment.html
Until there is an actual approved product the purpose is experimental. So any device sold for DC cell production (unless to Dendreon or APCEDEN) is for experimental use.
The actual approval decision just lists 2 trials, DCVax-L for nGBM and for rGBM patients under 18 and at least 6 pounds. No more detail.
I am also curious if the assertion that the PIP trial(s) must be launched is true.
All I see in the PIP is that they were granted a deferral and that the PIP is complete summer 2028.
EDIT: Thanks flipper, missed that. So it says they do not have to be initiated prior to submission. Where does it say prior to approval?
CO's share count number comes from OTCMarkets site which gets it from compushare which is the registra for NWBO (and many others). It is accurate.
What is not know though is how may preferred shares that can convert to common have been issued.