NWBO: Once In A Decade Best Stock Investment -- Regulatory Approvals Coming! [Dec10, 2022 在第一页加了中文简述]

After CPI data, Wall Street has to shed some blood for its misleading prediction from the last few days. FED is certain to raise rate at least 0.75% and the chance of a 1% raise is increasing later this month. So would $NWBO swim against the tide? A couple of cents increase may be reasonable.
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GlobeCitizen 说:
After CPI data, Wall Street has to shed some blood for its misleading prediction from the last few days. FED is certain to raise rate at least 0.75% and the chance of a 1% raise is increasing later this month. So would $NWBO swim against the tide? A couple of cents increase may be reasonable.
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Lots of talks about a BO or partnership with MRK - base on Keytruda/ DCVax performance？ and Dr. Liau being quoted “what I’m excited about is that we’re seeing a growing number of long term survivors in our patients treated with immunotherapy combinations”.
Just exactly how good is Keytruda/ DCVax combo. All I know is, it’s the only combo that went on to P2.
 
The chatter's always there. Partnership may happen anytime based on combo trial in which DCVax-L is an essential element. In one trial with Merck's Keytruda, etc., conducted at UCLA, terminally ill cancer patients have 50% remission or cured. If there is a buyout, it would happen after UK approval.
 
GlobeCitizen 说:
The chatter's always there. Partnership may happen anytime based on combo trial in which DCVax-L is an essential element. In one trial with Merck's Keytruda, etc., conducted at UCLA, terminally ill cancer patients have 50% remission or cured. If there is a buyout, it would happen after UK approval.
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When do you expect UK approval?
First Q next year? UK approval fast track approval should be very fast?
 
The approval of commercial manufacturing lisence is a sign to watch for imminent approval of DCVax-L. The manufacturing license approval may come from late this month to Nov, after that approval of DCVax-L for GBM will follow very quickly. Also importantly is whether both nGBM and rGBM are involved in the approval package.

In a less optimistic view, since the company has not announced either submission or acceptance of its MAA (marketing authorization application, aka DCVax-L approval application) yet, it may take a longer time to get an approval.

My personal guess is the company has been making utmost effort to first get UK approval so that a deal can be struck in a fair price. The successful suiter (a big pharm like Merck) will then pursue approvals in US and ROW (the rest of the world) in a way much easier than the company would by itself.

So UK approval will be a key step.

As an aside, biotech investing is utterly different from normal investing in big cap companies where investors would set stop loss order, either 15% or 20%, to limit loss in case of unpleasant events. In small cap biotech world, manipulation is rampant, naked and wild, if an investor doesn't want to be taken out (by manipulation for example), he/she should not set any stop loss orders. If ones have no stomach for big gain/loss even with solid DD, by all means do whatever is appropriate to do.

GL to you and all other fellow investors.

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GlobeCitizen 说:
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Saw an interesting posting by DanishDude this morning:


The PIP trial terms and the deferral have been approved. NWBO can apply for MAA and the MAA is not intended to be delayed with deferral until the PIP trial has been completed, It is approved and the basis of approval is in the PR.

Let me quote Hoffmanns excellent example.

I'm going to use the most recent example. Just fyi - I looked at 3 partial compliance checks and 2 full compliance checks and this one had the longest compliance check timeline, so I believe I'm being conservative with my number(s).

Evinacumab
Final PIP Decision Letter = 5-19-22
Decision Date on Compliance Check = 7-11-22 (53 days)
MHRA approval = August 2022

now lets apply those timelines to DCVax-L

DCVAX-L
Final PIP Decision Letter = 8-17-22
Decision Date on Compliance Check (53 days) = October 9, 2022
MHRA Approval = November 2022

One can look at the MHRA website for themselves, but some other dates I saw were:

Eribulin (full compliance check)
Final PIP Decision Letter = 3-11-22
Decision Date on Compliance Check = 4-4-22

Alpelisib (partial)
Final PIP Decision Letter = 4-22-22
Decision Date on Compliance Check = 5-4-22

Exenatide (full)
Final PIP Decision Letter = 12-13-21
Decision Date on Compliance Check = 12-22-21

Again, no apples to apples comparisons but it is interesting to compare actual timelines to get a really rough idea of what NWBO might be looking at.


Any comments?
 
I have been in this for years knowing how this mom and pop shop works. Nothing is lacking but patience. Things have moved forward in a tortuous way. So if one has decided to hang on to see through this (drug approvals and beyond), he/she would not be too keen on those overly zealous message board posters.

Nonetheless, the information is relevant, more for big pharmaceutical companies as demonstrated in your cited cases above.

We as investors have no doubt hoping things can move a little bit faster when it comes to anything, everything NWBO. If the precedents are a mirror, yes definitely this month and the next will be interesting.

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GlobeCitizen 说:
I have been in this for years knowing how this mom and pop shop works. Nothing is lacking but patience. Things have moved forward in a tortuous way. So if one has decided to hang on to see through this (drug approvals and beyond), he/she would not be too keen on those overly zealous message board posters.

Nonetheless, the information is relevant, more for big pharmaceutical companies as demonstrated in your cited cases above.

We as investors have no doubt hoping things can move a little bit faster when it comes to anything, everything NWBO. If the precedents are a mirror, yes definitely this month and the next will be interesting.

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Any comments on AIVITA ‘s AV-GBM p3 results. DVVax-L direct competition?
 
By quickly scouting it, it seems AIVITA ‘s AV-GBM p3 results does have something innovative in that it uses short-term cell cultured autologous tumor cells for antigens, unlike DCVax-L where it uses whole tumor cell for antigen sources. Nonetheless, the AIVITA ‘s AV-GBM trial is not a p3 trial but a p2 trial. More importantly, the trial is an open arm, single arm trial so the road ahead is still long, not in any immediate competition with NWBO's DCVax-L.
 
Key points of Prof Keymours Ashkan's presentation (nothing new there, more of educational purpose IMO):

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This guy pgsd has a good compile of excerpts from 10 May NYAS presentation:

Primary endpoint met (mOS in nGBM),
WITH STATISTICAL SIGNIFICANCE

Secondary endpoint met (mOS in rGBM),
WITH STATISTICAL SIGNIFICANCE

Excellent safety profile

First phase 3 trial of a systematic treatment in 17 years to show a significant extension of mOS in nGBM

First phase 3 trial of any type of treatment in 27 years to show a significant extension of mOS in rGBM

One of the first, if not the first, phase 3 trial to show meaningful increases in the long-term tails of the survival curves in both nGBM and rGBM

PFS endpoint not feasible due to PsPD. So, SAP focused on OS, and specified OS as the primary endpoint before unblinding.

The Statistical Analysis plan and it's endpoints were pre-specified and submitted to regulators before unblinding.

Broader Perspective
• DCVax-L suitable for combinations with wide range of
other treatments
(checkpoint inhibitors, oncolytic viruses, cytokines, chemo, etc.)
• When a DCVax-L patient has recurrence(s), new batch(es)
of DCVax-L can be made
(treatment targets not lost, as they are with targeted therapies)
• DCVax-L can potentially apply to any type of solid tumor
(multiple other cancers treated in compassionate uses cases and
a prior small pilot trial)
• DCVax-L can be administered in community settings as well
as major cancer centers.

• The completion of a large, phase 3 trial including 331 patients,
94 sites, over 70 clinical investigators, in 4 countries using an
autologous, dendritic cell, tumor lysate (DCVax-L) shows
efficacy to meet the primary and secondary end-points of an
increase in O.S. for nGBM and rGBM
• The vaccine is easily administered and has a favorable safety
profile.
• The use of external, contemporaneous clinical trials (n = 5 for
nGBM and n =10 for rGBM) is innovative, and going forward,
could be transformative given the poor track record and
numerous failed trails in neuro-oncology.
• There is a significant percentage of long-term survivors,
consistent with an immune memory effect by the T-cells,
potentially changing the natural history of GBM from a
uniformly fatal to a chronic, manageable disease.
Specific subpopulations show an unanticipated benefit
including; a) older patients, and b) patients with residual
disease after surgery. As expected, patients with methylated
MGMT promoter fare better than unmethylated group.
• The feasibility of the vaccination process enables widespread
application in the community setting, as well as in major
academic centers of excellence.
• The use of dendritic cells as the master, professional antigen
presenting cells allows for combination therapy using other
approaches such as blockade of immunosuppressive
cytokines, CAR T cells, viral oncolytic therapy, electric field
therapy, DNA vaccines, etc.
• Preliminary data shows evidence of T cell infiltration into the
target tissue (Glioblastoma).

Summary
Patients treated with DCVax-L showed a
clinically meaningful and statistically significant
extension of survival…
…in both newly diagnosed and recurrent GBM,
…with an excellent safety profile, and
…noteworthy long tails of survival.


Today's market is already in a bloodshed due to worse than expected CPI data in the US. NWBO price may suffer as well but I expect it may recover or even go higher toward the end of market close.

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