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Msg  57219 of 57658  at  12/2/2023 10:00:48 PM  by

GaryM


 In response to msg 57215 by  Topexec
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Re: NWBO

Oppy, people, as you see here either love, or hate NWBO, I love it. 
 
Here's why.  You can completely disregard the Phase 3 results which nearly tripled the percentage of patients living to 5 years with GBM, normally it's 5%.  You cannot disregard what's been done at UCLA where they added Poly-ICLC and/or Keytruda, both products which failed in GBM by themselves, and they're data to date is supporting over 50% survival at 5 years when used in conjunction with DCVax-L, though they identify it differently in the UCLA trials, they openly state it's DCVax-L that they're making there with NWBO concurrence, but NWBO is not a sponsor of these trial.
 
For GBM alone, with worldwide distribution, this will be a blockbuster drug many times over, even if the share count expands to 2 billion, which is .3 billion more than what's authorized, I believe a market cap in the $25 to $50 billion range will be a reasonable target in a few years.  This however is just the tip of the iceberg.
 
The company has been very open about going for a tumor agnostic label, it may not be achieved in the UK on initial approval, but in the UK under compassionate use the vaccine has been made with a variety of cancers and anecdotal evidence of efficacy seems to be excellent.  I don't know if that will be part of the submission, or not.
 
The vaccine is made from the lysate from the tumor and leukapheresis done when the vaccine is to be made at some time after the surgery, and proper cryogenic preservation of the tumor. 
 
The peer reviewed journal created some confusion, though it was very positive for those who understood what was happening.  They presented both PFS data and OS data, but frankly the PFS data should clearly have been ignored.  Why?  Because progression was called for patients who actually had pseudoprogression and while the tumors appeared to grow in the scans, it was found to be dead matter, the patients were getting better.  Sadly the goals in the US hadn't yet been changed, and they really didn't do a proper job of stating this and shorts, like AdamF called it out and brought the stock down.  Perhaps most importantly while survival was clearly improving, why it was improving really hadn't been determined or explained, and wasn't explained until a non peer reviewed presentation by Dr. Bosch, an officer of the company, was made in the ASCO Experts Theater.  In that presentation, for the first time it was discussed to my knowledge, it was shown that with the vaccine, the patients T-cell population grew by a factor over 10, as I remember it.
 
I believe the T-cell growth is the key to the vaccine working, and that will truly prove to be tumor agnostic.  I can't say that Poly-ICLC and/or Keytruda will prove to create as great an advantage in other cancers, but getting your own  T-cell production up, and keeping it up with routine boosts of the vaccine, is what I think is achieving the major benefits that have been seen both in GBM and other cancers anecdotally.  Remember, because the vaccine comes from your own cells, and these are your T-cells that are multiplying, there are virtually no negative side effects from the vaccine.
 
I know this is a lot to take in, but imagine how big DCVax-L could get if it were used in most of the deadliest of cancers as part of the SOC.  If the company isn't bought out, it could be as big, or bigger than nearly all the BP's.  If it is to be bought out, years ago the CEO indicated nothing under $20 a share would be considered, but with what they know today, I believe it would be substantially higher. 
 
By the way, the above is only what DCVax-L is doing.  DCVax-Direct is made with only  leukapheresis and it's injected directly into inoperable tumors and works to create DCVax-L inside the tumor.  It's development was put on hold by funding after some Phase 1/2 results, but it showed efficacy.  With funding it will be advanced into a registrational of pivotal trial in the future.  The approval process will probably be at least 5 years, and more likely longer, but can you imagine how big this could be.
 
Those bashing NWBO are doing so largely because their trial, which took well over a decade, was dramatically revised mid trial when the pseudoprogression was determined.  In that all patients in the control group had already been permitted to cross over it created a trial in which there was no control group.  The criticism is this wasn't part of the initial trial as it required historical data of some sort to be used to judge the trial.  OS actually had been goals as well from the beginning, with the cross over design, the regulators actually had to recognize that OS could only be judged by making comparison with other data.  The FDA actually wrote a Journal article on how trials in the future would consider these concepts, but it's not yet finalized in FDA documentation, and when it is, they may have to stretch a bit to accept what was done, but I believe that they consulted in depth with all four regulators.  In Europe and the UK the authorities changed their version of Clinical Trials to make OS primary, but did continue to show PFS rather than completely abandoning it.  In the US it was the companies responsibility, and they took their sweet time and it wasn't done when data was presented at SUNY of the vaccine.  Dr. Liau got Covid in the UK, another Dr. made the presentation, but AdamF argued that she was ducking the failure, put down the PFS data, and after a big rise before the presentation, he and other shorts tanked the stock.
 
Certainly there are things the company could have done better, most of the time they work in secrecy, but sometimes they're too open.  They announced they expected to file in the UK before now, then they announced a couple delays.  It should come in the next couple week, unless there are further delays.  This is a case where they said too much, and would have been better to simply stated they expected to file this year. 
 
The company in the few years I've owned it really only gives limited guidance at the Annual Meeting, which hasn't been held yet this year, but could still be.  Last year they did it the last business day of the year as I remember it.  The key to mass production is the EDEN device from FlaskWorks, which they bought from Corning glass a few years ago.  It must be proven to be equivalent to vaccine made in manual cleanrooms, which is how it's been made to date.  The EDEN unit will bring production cost down to a tiny fraction of what it will take to make each batch manually in its own cleanroom.  In its final configuration I believe the EDEN will be fully computer controlled during the roughly one week it takes to make each batch of vaccine.  The vaccine itself will be in a disposable cassette that never actually touches the ADAM unit itself, pumps, like those used to meter IV fluids move the product through the cassette.  The units are about the size of a computer printer and many can be housed in a single clean room where they're loaded and unloaded, vials are properly filled and the vaccine is cryogenically stored until it's to be distributed and used.
 
There is a lot to be revealed, and I believe the company has a plan which will achieve approvals from all four regulators, hopefully all four next year, but I don't know that.  Clearly they'll need funds to do all that needs to be done, but they do have plenty of shares authorized, if they don't establish partnerships once they achieve higher prices, which should come with UK acceptance, it won't take that many shares to fund what's needed. 
 
I think the IMGN buyout is premature and I know you agree, I hope it fails, or that we get a much bigger offer.  I feel the same about NWBO, I would hope that they don't take in an equity partner for under position: absolute;0 a share from the partner, nor a buyout before it's determined that the vaccine is truly tumor agnostic, or not.  If the vaccine is tumor agnostic and will be used as part of the SOC in many cancers, the share price in a buyout should go well into triple digits. 
 
You can get the bashers side from many other people, most are far more medically knowledgeable than me, but not more than some I know.  My own spinal surgeon knows Dr. Liau and bought in when he looked into it, and has others in his office who've done the same.  He also does some brain surgery, but isn't part of the trial.  He's moving his main practice to New Jersey, but his brother still works at Cedars, and he told me he'd fly in to assist if I need surgery if asked.  There are regular posters on I-H who have substantial medical knowledge, some are basher, others supporters.  I think much depends on whether you believe the regulators can do what's right, even if it's a big change to how they've done things in the past.  I believe that DCVax-L along with Poly-ICLC and/or Keytruda is such a major breakthrough that they can't ignore the advancement it will make.  The approval may only be for DCVax-L, but the Poly-ICLC and/or Keytruda should be readily available off label until confirming trials are done, if demanded.
 
Gary 
 
 
 
 
 
 


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