Can someone tell me,because I just cannot find the right info, how many outstanding shares the company has
when fully diluted? Thank you very much for sharing.

Could take at least 6-8 months before trials results will be disclosed: first sending the SAP to all regulatory agencies, then the SAP must be approved, data lock, unblinding the results and then finally release of the results.

I understand.

If LP succeeds in changing the SAP and if results are clinically and statiscally significant.
But a reverse split is needed if LP is not open for buyout propositions.

Wouldn’t it be a good thing if they would do a reverse split and do a huge capital infusion/dilution to become attractive and be in a stronger position to negotiate partnerships or buyout?

Thank you

He not even has a profile on LinkedIn!

Great news. They can loan upto $15m dollar to bring Tonmya to the market and continue maturing their trials: “the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $15.0 million worth of shares of the Companys Common Stock” —> they can use Lincoln as their bank. It is great news in fact, because they have financial security while they’re also expecting the share price will soon be over $1/share.

http://www.conferencecalltranscripts.org/8/summary2/?id=6613752

Please explain...

Two weeks ago. He said he couldn’t not give an exact timeline, but also that he would not expect it to take very long before FDA submission, more like within two months.

I have, as you have read: SAP submission within 2 months (2months-1week now)

Super. Thank you

I agree.

I don’t know. I hold a substantial number of shares and did show my position in my first e-mail to him.

Dinnes@nwbio.com Please do tell us what you asked and what info you got back, like what I did to this board.

I e-mailed Dave Innes, he gave me his mobile phone number and called him.

Again: call him. Or e-mail him and then call him: Dinnes@nwbio.com

Just call IR.

After all the efforts Linda Powers has put in DCVAX-L, I never believe she would sell her company for less than 10 billion dollar.

Just call Dave Innes for more info. One thing to add: regulatory agencies are more than willing to help, because they agreed with the crossover design which was used more than expected by patients jumping to DCVAX-L.
As soon as the SAP is agreed by the regulators the results get unblinded and the topline results will be released before the end of this year.

I have talked with IR. The SAP will be submitted between now and 2months max.

Keynote-407 was NOT performed in Europe.
Crossover here is 67-69%

Instead of most small biotech companies,NWBO put a lot of effort in screening the right patients before they could enter the trial. That’s a very good sign.

Many international studies? Ok, name a few more than. P3 oncology studies with a crossover design, conducted recently (later than 2013).

If this great story is not an exception, DCVax-L will be used as SOC as add-on to chemo/radiation.

This trial is conducted under FDA and EMEA. That makes it pretty much impossible to stop early due to superior efficacy b/c both agencies have other values to determine what is called superior or not. Plus b/c of the option to crossover makes it pretty much impossible for agencies when to determine superiority or not, b/c you have different subgroups.

The FDA decision to (dis)approve the SAP will determine which endpoints will be evaluated. Only in a very few cases the FDA approves a drug when it fails the primary endpoint and in such cases the name of such companies sound like GSK, AstraZeneca, ...
IMO the FDA will approve the SAP -otherwise I would not be holding shares of NWBO -because the FDA in the first instance approved the crossover protocol. Now that 90% of all participants received DCVAX-L, from which there are about >67% of all crossover placebo patients, the FDA has no other option to agree to take an other endpoint as primary endpoint to determine the effectiveness of DCVax-L (statistical difference of 30 placebo patients vs DCVax-L patients is too low).
It is now upto the FDA and NWBO’s biostatisticians to determine the SOC OS and PFS surivival from historical data and determine which number of extra months must be archieved as a minimum to get statistical significance (p<0.05). Most important should be OS.
If they can show mOS is statistical significant better than placebo, we make a home run.
If they can show a survival tail of +5 years in >15% respondents AND/OR longer survival at recurrent GBM the sky is the limit.

I agree. If NWBO can prove to GBM patients that they’ve 33% chance of surviving more than 4years and longer, so 1 chance out of 3, the FDA will approve DCVAX-L. And certainly because DCVAX-L is an adjuvant treatment to SOC chemo/radiation.
If you can say that living 4years longer is a kind of cure, than DCVAX-L could be considered a cure for 33% GBM patients. That is huge! Meaning a MC>$8b

If the same results can be attained with other solid tumors with DCVAX DIRECT, the sky is the limit.

Based on the potential of the rest of their pipeline, that would be a possibility.

This is a great recent article about DCVAX-L.You really want to read this, I prefer this quote:
“Time is of the essence! My life has changed forever, I am currently unable to work as a registered community psychiatric nurse (a job I absolutely love) and I no longer feel independent. I was a proud working mother and now, suddenly, I’m not, I can’t even drive! I need your love, support and prayers more than ever. Family and friends want to give me the best fighting chance of survival. I’m currently undergoing daily Radiation and Chemotherapy at Queens Hospital in Romford (Dec to Mar 2019). Incredibly, the NHS do not support other forms of cancer treatment, however, there are some patients in the US & Europe who have seen a dramatic change in their prognosis and who are going into remission after receiving alternative treatments (i.e. immunotherapy, frankincense, CBD, DCVax, etc.) to those commonly given for malignant brain tumours. This is what I am up against, and this is the kind of treatment I need!”

==> So, oncologists seem to experience positive results in the earlier trials and in the unblinded/crossover P3 part of the trial. Well, it doesn’t surprise me:
— giving presentations at ASCO means you must have a potential effective product, otherwise oncologists over there ruin your reputation forever.
— Linda Powers’ got a lot of acknowledgments on LinkedIn from eg the medical director oncology of GSK
— 68% of the 2:1 randomised P3 trial (DCVAX-L:placebo) placebo patients (68% out of 110) decided to take DCVAX-L the moment they could take it.
— the working mechanism is very logical
— working as a medical rep, I experience that many oncologists have high hopes on dendritic cell treatment, eg metastatic breast cancer
— a lot of publications in medical journals, ...

Here is the link of the article:
https://www.justgiving.com/crowdfunding/becs-fight

Could DCVAX-L be considered as a cure for a specific subtype of GBM patients and for other subgroups as an effective treatment?

Thank you for this very important document.

Or by GSK since the medical director acknowledges the performance of Linda Powers.

It all comes down to the P3 results. If successfull, they will be bought out by Merck or Novartis for $5-10b.

Great news. The upcoming quarterly report will take this to $.20 or more

“Follow-up survival data from the Information Arm patients who did not qualify for the Phase III trial are encouraging and appear consistent with the blinded interim data from the trial. In the group of 25 Information Arm patients who had actual or apparent early tumor recurrence, the follow-up data showed that 40% of the patients lived for 3 years or more, 20% of the patients lived for 5 years or more, and 12% of the patients are still alive at 7 years. “
Highlights Of NW Bio's Program Update In The Industry Expert Theater Presentation At ASCO
https://finance.yahoo.com/news/highlights-nw-bios-program-industry-142400175.html

I see a stock which has a MC>$100M. That gives credibility. I see clinical sites opening for DCVax-direct (Meaning they trust management). I see most of the GBM trial population chosing to crossover to DCVax-L when they were put on placebo at first.

Look at the LinkedIn page of Linda Powers and to the people that acknowledge her performances. Even the medical director of oncology of GSK gives credit to her.

Look at the LinkedIn page of Linda Powers and to the people that acknowledge her performances. Even the medical director of oncology of GSK gives credit to her.

Ye$$$