Great article.

I know some breast oncologists in Europe and their expectations for a dendritic cell vaccin are very high, hoping one day in the not so far future it can be used.

She will do that for $15-20b + a board seat in the company that buys us out.

I LOVE THE SILENCE FROM NWBO. THEY ARE PREPARING FOR BREAKTHROUGH RESULTS

Even the competition has no arguments why dvcax-l would fail. This is going to explode! TLD in September!!

The article makes me even more bullish

Indeed.And this is why I´m bullish. The competition has no arguments at all against dcvax-L.

dcvax-l got a positive note in a very negative, recent article "While the interim analysis from the trial showed an eight-month OS survival benefit for the addition of DCVax-L to SoC, key stakeholders in the field have indicated potential patient selection bias (7,14)" The KOL comments she is referring to are posted in my previous post. You can see not all KOLs agree with what she is saving.
https://www.cellandgene.com/doc/immunotherapy-for-glioblastoma-a-path-forward-0001

Read this (unbiased,makes me bullish): "Despite the highly promising data, many key opinion leaders (KOLs) interviewed by GlobalData had mixed views about the dendritic cell vaccine. KOLs noted that Northwest Bio’s data was presented in an unusual way for a randomised Phase III trial and the criteria for selection was highly meticulous with an estimated 1,599 patients screened and 1,268 of these patients excluded from the trial. It is speculated that only the patients expected to live longer were included in the study due to the scrupulous selection criteria, which could have led to bias in the dataset.

Despite some skepticism, other KOLs did have positive opinions about the data. DCVax-L is unique because it doesn’t target one particular antigen, but uses the patient’s own tumour specimen to create the vaccine. Even assuming an FDA approval, KOLs mentioned that the personalised vaccine may suffer challenges in terms of preparation of the vaccine. The logistics and requirements for creating such a personalised vaccine would be a barrier for DCVax-L being adopted in routine clinical practice."

https://www.pharmaceutical-technology.com/comment/northwest-bios-dcvax-l-hype-warranted-glioblastoma-patients/

Read this (unbiased,makes me bullish): "Despite the highly promising data, many key opinion leaders (KOLs) interviewed by GlobalData had mixed views about the dendritic cell vaccine. KOLs noted that Northwest Bio’s data was presented in an unusual way for a randomised Phase III trial and the criteria for selection was highly meticulous with an estimated 1,599 patients screened and 1,268 of these patients excluded from the trial. It is speculated that only the patients expected to live longer were included in the study due to the scrupulous selection criteria, which could have led to bias in the dataset.

Despite some skepticism, other KOLs did have positive opinions about the data. DCVax-L is unique because it doesn’t target one particular antigen, but uses the patient’s own tumour specimen to create the vaccine. Even assuming an FDA approval, KOLs mentioned that the personalised vaccine may suffer challenges in terms of preparation of the vaccine. The logistics and requirements for creating such a personalised vaccine would be a barrier for DCVax-L being adopted in routine clinical practice."

https://www.pharmaceutical-technology.com/comment/northwest-bios-dcvax-l-hype-warranted-glioblastoma-patients/

Can someone explain why the FDA granted this and 27 study locations (higly reputable hospitals) wanted to participate in "Expanded Access Protocol for GBM Patients With Already Manufactured DCVax®-L Who Have Screen-Failed Protocol 020221 (DCVax-L EAP)"
If they weren´t seeing remarkable results??
https://clinicaltrials.gov/ct2/show/NCT02146066?term=Dcvax-l&draw=2&rank=1

Question:when does Q4 start?

Never heard of pseudoprogression of course, never heard of SAP of coursz, never heard of the difficult path Yervoy ewperenced (was almost stopped in an early phase 3 phase).

At Least 5 billion dollar (Europe+US). That excludes DcVax-direct. I am not selling under 15 billion dollar market cap.

Great to see NWBO releasing news intraday. We might see that being repeated, resulting in unexpected bullish volatility. You look at the share price at 1:00pm being $0,37/share and after you have had a business meeting at 3:00pm the share price is $1,27/share

1 month... PT $5-8/share MONEYTIME,9TH INNING

10q:Everything on schedule for topline results in Sept
Only IDH mutation analysis,then data lock. Top line results in Sept. It is MONEYTIME! YE$$$

That would be awesome.Great 10q report, data lock almost completed and ready to explode.

They do have sufficient capital now.

GREAT NEWS(Monday .40-50/share):all existing warrants (75million) are suspended to get exercised till December 15 and all new warrants are suspended to get exercised till December 15 as well ==> NOTHING IS HOLDING THE STOCK BACK TO RISE NOW!!!

Just a very small dilution now till the P3 results at a very positive discount of only 4%!

NWBO will be at > 1$/share before the results will be announced.
PT $5-8/share

https://sec.report/Document/0001104659-20-092026/

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=157442313

We´re going to be extremely rich when P3 results are positive. PT $5-8/share without considering dcvax direct.

Great find

I AGREE.

"All of the new warrants issued in the Offering are suspended until December 15, 2020.

 In addition, as part of these agreements, the investors who have existing outstanding warrants that have not yet been suspended are now suspending approximately 75.6 million additional existing warrant exercise shares until December 15, 2020."

 

You should have covered your short position when the Wolfpack decided they were leaving NWBO after a fabulous, epical performance keeping the share price this low. Now you are on your own, and a bullish invasion is a fact.

GREAT NEWS:all existing warrants (75million) are suspended to get exercised till December 15 and all new warrants are suspended to get exercised till December 15 as well ==> NOTHING IS HOLDING THE STOCK BACK TO RISE NOW!!!

Just a very small dilution now till the P3 results at a very positive discount of only 4%!

NWBO will be at > 1$/share before the results will be announced.
PT $5-8/share

https://sec.report/Document/0001104659-20-092026/

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=157442313

GSK did it,before buying out HGSI. Of course no legal connection.

Warrants exercised

To continue my thesis:slide 24 of the presentation: could it be that 34% of the unmethylated patients that were in the top 100 survivors, were the ones that immediately got the injection - and not getting the placebo first and afterwarts crossed over to DCVAX-L?
Is the effcicacy for DCVAX-L in unmethylated patients at its’ best, or even maybe only working, when receiving immediate injection? That thesis will only make the statistical strength in favor of DCVAX-L compared to placebo (and compared to historical Chemo+radiation data) and indicate that DCVAX is a breakthrough in brain cancer treatment.

https://nwbio.com/wp-content/uploads/Boston-Presentation-v0.2.pdf

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=157437714

My thesis why NWBO will show superior results is based on the presentation of Marnix Bosch, CTO of NWBO at the inaugural Glioblastoma (GBM) Drug Development Summit being held at the Westin Boston Waterfront Hotel in Boston, Massachusetts on Dec 11 2019.
link: https://nwbio.com/wp-content/uploads/Boston-Presentation-v0.2.pdf

First of all you should know presentations need to be accepted before shown in public.

Slides 3+4+6+7: Shows that NWBO can explain how DCVAX-L works. DCVAX-L has a clear working mechanism and it is important for the FDA and EMA that you can explain how your product works when you are filing for commercial approval.
Slide5: shows that DCVAX-L can be immediately used+produced when the GBM patient meets the criteria for the treatment.

Slide8: Positive P3 results will result in FDA and EMA approval (P3 trial in the US, Canada and Europe)

Slide9: multiple injections for DCVAX-L to keep boosting the immune system. I like it, because I do not believe one sole injection is sufficient to have a permanent change in immunity to defend against cancer. It is a fixed schedule of injections, which makes it easy for oncologists to perform and to plan. Multiple injections=more money for shareholders
Slide 9: 90% of all patients have received DCVAX-L, which means that almost everybody agreed to crossover. It must be that not only the "placebo" patients wanted it when their disease progressed, but also that oncologists must have really pushed their patients to give it a try. Why would they do that? The only reason I can think of is that oncologists must have felt really comfortable with DCVAX-L. Could it be because all oncologists have experienced/heard about positive results from phase 2 patients and compassionate use patients that are unblinded?

Slide 16: more unmethylated than methylated patients
Slide 17-21+24 : historical data (Temodar+radiation):
==> mOS methylated patients: 21,2 months
==> mOS unmethylated patients: 14,7 months

results from the DCVAX-L trial from the entire population (placebo, crossed-over group to DCVAX-L and DCVAX-L from the start):
==> survival at 2 years: 46,4% (survival at 3 years 28,2%)
==> interim data at 2018: survival at 2 years methylated: 66%
survival at 1 year unmethylated: 86,4%, 2 years 32,6%

Of course results are unblinded, but I find it very hopefull that 66% of the methylated patients were living more than 2 years (whereas in the best historical studies, data shows that 50% of the methylated patients died at 21.2 months). I also find it encouraging that 86,4% of the unmethylated patients were still living at 1 year, making the odds high that the unmethylated DCVAX-L patients would do better than 14,7 months in historical data (certainly when you see that 32,6% were still alive at 24 months)+because of the fact that 34% of the top 100 of longest living patients were unmethylated..
Keeping in mind that most of the placebo population agreed to cross over, makes me conclude that DCVAX-L increases the life expectancy of unmethylated and methylated GBM patients.

IMHO we have a clear winner and a breakthrough in GBM treatment.
Personal PT $5-8/share (excluding DcVax direct pipeline)

I agree,first target for nwbo $5-8, then higher

It has had its´ run,NWBO to gox10-20

They recently sent a SAP to change the primary endpoint into somerhing that has a better correlation with immunotherapy, which is the long tail OS curve.

Thumbs up

Indeed.

If DCVAX-L was bad,they would not have been granted expanded use protocol. https://clinicaltrials.gov/ct2/results?cond=&term=Dcvax-l&cntry=&state=&city=&dist=

Very bullish

Because she gets so many acknowledgments and LINKEDIN is a non-anonymous social media site.
Have a look: https://www.linkedin.com/in/lindapowers

Have a look at LP Linkedin page. All these references and acknowledgements from the medical community!
I am sure the wolfpack will be gone here on time, I just feel sorry for all the people that were misled by them and missed this enormous opportunity.

With DCVAX-L we already have proof that people with GBM can survive more than 5-10years. There is also compassionate use for DCVAX-L. This makes me sure we will see $5-8/share in a couple of weeks.

Well, he is STILL ALIVE.