Duffy will support it, he has all the expertise with Keytruda.

Indeed+Boston, December 10-11 Time: 11:40 am - Day: Day Two Speakers: Marnix Bosch
DCVax Technology: Leveraging Activated Dentritic Cells in Clinical for GBM

https://glioblastoma-drugdevelopment.com

All pieces are coming together.

Very good news!

And IF P3 results are positive, they will be groundbreaking.

Thank you all for your answers. All I know from oncologists is that there is some enthousiasm about the potential of dendritic vaccines. What I think is that Merck will buy them out for cheap for something between 5 and 20 billion when P3 results are good, considering the rest of the pipeline (DCVax direct).
The odds of approval is now in the hands of the regulatory agencies allowing NWBO an adaptation of the SAP. I like the quietness from management abou that. It must be nerve wrecking for shorts because: news could come in any day now. And this news will enhance the odds of FDA and EMEA approval + will trigger a short squeeze.

What would the market cap be worth if DCVAX-L meets the primary endpoint?

Yes.Roche needs to do something to keep up with other competitors.And Roche buying out NWBO is not too far fetched.

If Merck does not buyout NWBO after positive DCVax-L results they won’t be able to monopolize the combination of Keytruda+DCVax-L, Keytruda+DCVax direct, because BMS,Bayer, GSK, Pfizer, TEVA, or AstraZeneca will buy them out.
Don’t doubt about it, NWBO will be bought out if P3 results are good.

We usually see Merck appear in companies which are at phase 1or phase 2. Then, more than often, Merck ends the partnership because of inefficiency of the product.
Now Merck appears, with mr Duffy -one of the big guys who developped and introduced KEYTRUDA >$50b to the market, for DCVAX-L, at the end of phase3 when results are almost coming... $$$

Great post

Maybe you should read more about his accomplishments at Merck!

"Conclusions:The addition of DCVax-L autologous dendritic cell vaccine to SOC is feasible and safe. Collectively, the blinded interim survival data suggest that the patients in this Phase 3 trial are living longer than expected. These findings warrant further follow up and analyses."

J Transl Med. 2018; 16: 142.
Published online 2018 May 29. doi: 10.1186/s12967-018-1507-6

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5975654/

If you were a GBM patient and you would have 1/7 (+/- 15%) chance to live longer than 4 years with DCVax-L or only 1/20 (5%) with SOC only, would you take DCVax-L, would you approve it being FDA/EMEA/... would you reimburse it as insurance company?
3x yes

It is too complicated. If Mercks’ ex-employee Duffy is that enthousiastic of DCVax technology, their will be a bidding war between Merck-BMS-Pfizer-Astra-GSK if DCVax-L shows positive results.

New article on SmithonStocks: https://smithonstocks.com/northwest-biotherapeutics-managements-decision-to-determine-survival-tail-for-dcvax-l-in-phase-3-trial-in-newly-diagnosed-glioblastoma-was-absolutely-the-right-move-nwbo-buy-0-25/

INDEED, PFS:probably mistaken with pseudo progression and number of deaths not yet met -knowing due to the crossover design only +/- 30 patients have not taken DCVax-L- we are going to see superior results.

On Feb 2017 the number of PFS was reached, but more than 2,6 years later the number of deaths has still not been reached. What does that tell us? Do I hear a $20b buyout?

Also “The Company reiterated that its Phase III trial was already solidly designed prior to the enhancements just announced, with a conservative assumption that the extension of Progression Free Survival (PFS) in patients treated with DCVax-L in the Phase III trial would be only 1/3 as long as the extension of PFS (compared to PFS with standard of care) that was seen in patients treated with DCVax-L in the Phase I/II trials. This conservative assumption in the Phase III trial design was and is also combined with strong statistical powering in the trial design (with an anticipated “p value” of 0.02).”
Since p must be below .05 to be statistical significant, the company has even more safe room to be statistical significant on PFS.:
“The enhancements of the Phase III trial do not in any way seek to “rescue” a trial that is already strong and solidly designed. The changes seek to prevent external variables from potentially distorting the results of the trial, while also having the added benefit of further lowering the threshold for the primary endpoint to be met from 6 months’ difference in PFS to 4 months’ difference in PFS between patients treated with DCVax-L and the control arm. This is a further de-risking of the trial, and as such is a valuable enhancement.”

https://nwbio.com/nw-bio-corrects-ongoing-false-claims-by-feuerstein-about-phase-iii-trail-of-dcvax-l-and-interim-analysis/

“In the DCVax-L Information Arm, for the 25 GBM patients with apparent early tumor recurrence at one of two time points, 40% of the patients had reached or exceeded approximately 3 years’ survival. This substantially exceeded the expected survival time of about 15 months even for regular GBM patients without early tumor recurrence.”
https://nwbio.com/nw-bio-issues-statement-on-adverse-market-conditions-and-nw-bio-stock-decline/

Feb 2017 “NW Bio Announces Lifting of Clinical Hold on DCVax®-L Phase III Trial By FDA; Progression-Free Survival Events Reached; Overall Survival Events Not Yet Reached

https://nwbio.com/nw-bio-announces-lifting-clinical-hold-dcvax-l-phase-iii-trial-fda-progression-free-survival-events-reached-overall-survival-events-not-yet-reached/

AND THE NUMBER OF overal survival events is still not reached!! $$$$$

Key word here as well “pseudo-progression”

Also don’t forget from earlier trials:
“As previously stated, the Company’s steady progress continues to reflect the growing interest from both physicians and patients, and a growing awareness of the positive data from the Company’s prior clinical trials for GBM brain cancer. In those trials, patients who received DCVax® showed a median survival of 3 years compared with median survival of 14.6 months for patients who received standard of care (surgery, radiation and chemotherapy). Patients who received DCVax®also experienced a substantially longer time to tumor recurrence: a median of 2 years, compared with 6.9 months in patients who received standard of care. DCVax® was well-tolerated, with no toxic side effects.”
https://nwbio.com/nw-bio-reaches-25-clinical-trial-sites-open-and-recruiting-by-the-end-of-q4-2011-2/

Feb 2017 “NW Bio Announces Lifting of Clinical Hold on DCVax®-L Phase III Trial By FDA; Progression-Free Survival Events Reached; Overall Survival Events Not Yet Reached

https://nwbio.com/nw-bio-announces-lifting-clinical-hold-dcvax-l-phase-iii-trial-fda-progression-free-survival-events-reached-overall-survival-events-not-yet-reached/

AND THE NUMBER OF overal survival events is still not reached!! $$$$$

Key word here as well “pseudo-progression”

I meant say that the company is going to meet their primary endpoints because the IDMC has not stopped the trial yet. So it is a very good sign.

Correct me if I am wrong, but the IDMC has not stopped the trial yet because of not going to meet the primary endpoint. So the longer the trial takes, the better the outcome could be.

And what would be a reasonable buyout offfer after positive P3 results? $10-15b or more like $50b because of DCVAX Direct?

Someone on Yahoo posted this:
“We were told that 28% of the phase III patients survived and made it to 36 months which sounds good but 40% of the phase III patients have methylated genes, and such patients have median Overall Survival of 66.8 months with just current standard of care. So there is nothing unexpected about 28% surviving 36 months…
66.8 months for patients with methylated gene...
"Kaplan-Meier survival analysis showed that MGMT(methylated)/IDH1(+ve) was associated with a significantly longer OS 66.8 months (95 % CI: 0.0-167.8) and PFS 16.9 months (95 % CI: 11.1-22.7) when compared with MGMT(methylated)/IDH1(-ve) OS 15.5 months (95 % CI: 11.6-19.4) and PFS 9.4 months (95 % CI: 8-10.8) (log-rank, P?=?0.000) and MGMT(unmethylated)/IDH1(-ve) OS 11.1 months (95 % CI: 8.5-13.7) and PFS 6.3 months (95 % CI: 4.4-8.3) (log-rank, p?=?0.000)."

What do you guys think of that?

I agree. Also don’t forget the P3-ready trial for DCVax-Prostate.
If DCVax-L results are great-I expect they will be-Wall Street will be talking about nwbo for the next 20 years as the biggest biotech rise in the century.
I recently missed (one year or so) the jump of AQXP from $1 to $50
I was in BMNM when it was 0.20 (with 80,000 shares) but sold too early at $.42 instead of waiting to $3
I was in CVM with 11500 shares at $1.18 but sold at $3 instead of holding.

I just know NWBO (strenghtened with the 15m shares buy and Merck) that NWBO will be worth $20b at least.

Great post!

In my latest telephone call with Dave Innes,he made clear that -on the right terms- Linda Powers wants to sell the company after positive P3 results on DCVax-L. If I asked about the right teems he said he referred to recent buyouts of $8b-$15b and higher...

Indeed.

If they can show that 40% is still alive after three years and maybe show that 30% was still living at four years we win the jackpot.
Now I can understand why the company wants to get rid of PFS, it is because in GBM recurrence and progression is very common and happens very fast. It is all about survival.

Let’s just wait for the SAP being approved and in the meanwhile we can buy more shares.
Don’t forget ASCO 2019 (on DCVAX-L):
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.

This Information Arm survival data is especially encouraging since this group included patients who already had actual tumor recurrence as well as others who had the appearance of tumor recurrence but who could not be definitely determined. ”

Remember this from ASCO (on DCVAX-L)
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.

This Information Arm survival data is especially encouraging since this group included patients who already had actual tumor recurrence as well as others who had the appearance of tumor recurrence but who could not be definitely determined.

I agree. Meanwhile I buy more shares.

Adapting the SAP is something that is pretty common in biotech nowadays

One word: “Merck”

Yes

I agree.

Now that Toca failed, DCVax will be a true oncology blockbuster if DCVax-L shows positive results. The next “Keytruda”

You are right Flipper. I just want to say that when a big ex-chief from Merck says:”As I look forward now to the next wave of advances in immune therapies for cancer, I am excited about the potential of NW Bio's DCVax technologies to deliver new breakthroughs for patients.” the value of DCVAX -if DCVAX-L can prove its potential-is worth a lot more than just a couple of billion dollars.

If DCVax-L show positive P3 results,the value of the DCVAX platform will be estimated >$10b. Because Merck just shown interest in it and calls it the next step in immunotherapy.
A minimum buyout offer is $8b. $8b/1.2 fully diluted shares = $6,67/share

On the other hand I have seen buyouts happening in the oncology sector for $50b as well.