News Focus
News Focus
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Maverick0408

01/04/22 10:07 PM

#432074 RE: ou71764 #432072

Why would UK and EU accept new end points then?
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skitahoe

01/04/22 10:23 PM

#432077 RE: ou71764 #432072

OU,

I believe that anything is possible with our FDA, but I believe that in Europe they want the vaccine and will approve it. Many countries around the world will follow suit, and American's will travel to get it.

Fortunately, if this is the case, sales elsewhere will both support the share price and pay for whatever the FDA demands. I believe that a blind man could see the benefits of the vaccine, but sometimes the FDA can be deaf, dumb, and blind.

I do suspect that Biden's loss of his son due to GBM might have some influence on the FDA, especially if Europe acts to approve before the FDA takes any action. I frankly don't know if what Beau Biden had was what's currently defined as GBM, but as I see it, unless the data says otherwise, DCVax-L should be approved for many, if not all, forms of brain cancer.

I think we all need to remember that it's not NWBO's fault that many patients in the trial had diseases that today are not considered GBM, they were up to a matter of months ago, and at the time the trial began, IDH wasn't known at all as I understand it, now the FDA wants things broken down to the point that you're right, they could say there were not sufficient patients of any type. What should matter is all the people who're still alive, or lived much longer than anticipated, but they could be blind to such evidence.

Gary
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highwayman4life

01/04/22 10:29 PM

#432079 RE: ou71764 #432072

Understood and valid concerns given the sheer length this trial has been going on. Times have changed and the FDA along with other RA's recongnize this.

I feel the changes and buyin to the SAP by all 4 RA's was and is crucial.

Also take a look at FDA RTOR program:
https://www.fda.gov/about-fda/oncology-center-excellence/real-time-oncology-review

It is my opinion that NWBO has long been in constant communication with the FDA and to how to best approach the success of DCVax in spite of an archaic chemo/rad cancer trial designs.
https://acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33205

We will know soon enough if in fact NWBO is paving a new pathway for immunotherapy clinical trials designs/outcomes...hence the quiet period. Change never happens quickly, especially necessary change.

Best to you and the success of this long awaited trial and it's outcome.
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DavidW2

01/04/22 10:53 PM

#432082 RE: ou71764 #432072

Your logic has problem. If you think it will reach 35cents in year 2022. Why did you add more at 80cent in December? It means you don't believe your self. So you decided to add more at 80 cents.
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learningcurve2020

01/05/22 8:52 AM

#432127 RE: ou71764 #432072

Common sense talk but I think you're being far too charitable from a governance standpoint. Betting the CEO has known about a trial redux for years. Likely right around the time she moved to the OTC. Powers believes she's covered herself with that FDA endpoint cautionary guidance blurb, and she probably has. It's really people here and a few authors like Lappin ignoring that Powers letter to the FDA and the 8k cautionary statement, so always have to remind myself of that.

On another note, I'm guessing when LL realized management was spending the cash on building out and selling manufacturing facilities instead of furthering trials, that's when their relationship allegedly soured.

So very curious with what the SEC was looking at the last years and why they moved on?? Was it Germany or something else? Would've loved to be a fly on the wall when the decision was made to assign Flaskworks to NWBO instead of Advent.
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Sir Pumpernickel

01/05/22 9:18 AM

#432131 RE: ou71764 #432072

Well Said !!! My same exact feeling!! I don't believe the product failed, I believe the company did!! And yes, because it is now house money and not my original investment that I already pulled I choose to leave it in for the same reason as you!! It has just taken too long and the covid crap doesn't cut it anymore!!
Pumpernickel YuYUUUUUUUUUUU..............LaLAAAAAAAAAAAAAAA...........YuLAAAAYuuuuLAAAAAAAAAAAYuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuuu.......................AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWWHOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOOooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooooeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeee!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
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The Danish Dude

01/05/22 9:35 AM

#432143 RE: ou71764 #432072

That the company is waiting for a journal publication before relasing TLD is a huge red flag

1) In September 2020 NWBO aimed for publishing TLD quick

2) At data lock time October 2020, they had changed strategy and opted for a journal also

3) Thus there is NO red flag. They were blinded, so if what you say is correct, you argue they had known all along. That makes no sense at all then, having changed strategy during that month.

4) That change in strategy points to something completely else

a) Knowing they NEED journal to support data, in order to countermeasure shorters/hedges accusations/claims, realising SP would else not open for attack

There are no red flag and no red herring.

The rational solution comes from deducing according to what lies in front os us and let logic decide.

The red flag "solution" is full of "bias and want".

The smorgas table for bears.
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biosectinvestor

01/05/22 12:41 PM

#432258 RE: ou71764 #432072

The sunsets did not exist when the trial was designed, neither did the new definition of GBM. I do not think the FDA works the way you think it works.
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LessIsMore

12/21/22 4:28 PM

#551762 RE: ou71764 #432072

812,

Congrats for tying with Exwannabe for NWBO's year end price prediction.

Credibility matters!!

NWBO
Price Predictions for beginning of 2023

Posters Name Predicted Price Notes

Skitahoe $26.00
Redneck Hoosier $62.00
Dude $73.47
Captain Obvious $42.00
Hope 4 Patients $46.25
The Danish Dude $28.00 to $30
Pharmboy $15.00
Maverick $20.00 Buyout before end of the year.
Stonk Master $34.88
Sir Pumpernickel $- (Did you mean buyout before year's end?)
Jman $23.00
The Rover $27.83
Tilt My Brain $12.99
Kam $22.00
Flipper $23.00 upward to $73
Chiugray $50.00
Br8k Out $33.00 to $35 in buyout.
Joeycav $19.88
Know Fear $10.76 .875 x 12.30
Eagle $100.00 Plus
Scotty $4.50 to $5
Mionaer $14.00 In buyout
Hope for the Future $7.00
Sukus $10.00 To $12
X Master $27.50 After peak at $35
Marty Dg $0.22 To $12
Branster $2.00 Pop to $3 to $5 but back down
Stock Follower $66.66
H2R $17.00
Enoch $6.00 To $15
Hump $80.00
Hoffmann $12.50
Mi Dendream $14.75
Big Mahalo $11.45
Parmer $28.00 Approval and buyout.
Ccie $8.33
Voloda $69.00
Lorie $47.00 On buyout
Ou $0.35
ABC $33.00
10 Baggers $8.25
Big Al $25.00
Snowmonkey $17.00
Sun Bum $11.00
Veeets $88.00
Lefty $30.00
Survivor $46.00
Mhill $22.50
Meirluc $8.00
Kabunushi $4.00 to $8
Beachhyena $50.00
667849778 $4.05
Norisknorewards $1.70 After a high of $2.80
Marzan $50.00
Goodtimes $4.28
Spidaman $12.00
Ready4Nxt $17.00
Hspooner $16.00
Newman $75.00
Harvest $4.00 to $5
Lykiri $26.50
MXP $82.50
WJR $12.40
Gus $23.25
Sharkee $15.00
NeWBro $6.75 to $7.75
JDHeart $46.75
PPHMlover $5.55
DavidW $7.00 to $10
Whitewater $6.66
Stubby $2.50 to $11.50
Danouse $16.88
VMLG $7.00
JohnnyMacJohnJohn $15.00
Tursky $17.50
Reg $65.00
MN Pumba $3.85
Average Estimate $25.76