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For sure not a cure for cancer. This is a next generation immunotherapy with no side effects. How effective it will be is yet to be proven. But it has the potential to be effective on all solid tumors.
Cancer implies a single disease. Yet blood and lymph cancers are very different from solid tissue cancers. This vaccine won’t work for blood and lymph cancers. It does appear to be very effective against solid tissue cancers.
This is where the “somewhere in the middle” will come into play. The global market for treating solid tissue cancer is quite large (I’ve heard between $60-$100 billion). I’d expect DCVAX to penetrate the market quickly, depending on effectiveness. Still no side effects. Low hazard ratio for this treatment should have positive financial ramifications for government health care systems compared to the toxic chemo and radiotherapy systems currently being used.
I think our CEO wants to be a multi billionaire. That’s why she keeps buying shares.
Such is the potential in this investment
I had this discussion with a coinvestor earlier this week, debating on whether our investment was gambling or not. We both agreed that there is a CHANCE that DCVAX could not demonstrate long term efficacy. But we also both agreed that with the data that was presented, this chance is small.
We also both agreed that NWBO is currently priced with little or no CHANCE of getting to approval and significant revenue. While the CHANCE of success of the vaccine is significant, that isn’t priced into NWBO. That’s where the value exists here.
Final P3 trial efficacy data and regulatory acceptance are the only barriers to revenue here. There is no safety concern. This is a vaccine and platform that could change solid tumor cancer care. None of that is priced into the security, which only adds value.
I do wonder how the value perception will change with topline data. Can’t sell until then, even though there is a small CHANCE of failure.
MI Den...I don’t question your intelligence. The fact that you’ve calculated out the CHANCES and are invested here proves it to me.
Think of it as a “preview” of better things to come for GBM patients.
Bottom line is that share count is unknown until warrants expire or are exercised. That won’t happen until the company gets closer to revenue. But there will be cash generated for the company with the options.
The biotech game is to starve them of said cash and hope they go bankrupt before they can prove out a successful therapy. That’s why the winners share prices go wild when therapies are approved. Most companies can’t overcome the short attacks.
NWBO could be the rare case of a company on the ropes coming back to beat the market makers. Topline will be a defining moment.
550 million in warrants at .33 gets the company about $175 million in cash. What was the warrant liability on the last balance sheet?
No way. We start at $3-$5 billion and build from there.
It will be important to have somebody with institutional connections after topline when interest is generated among institutional investors.
If they knew the control data, then they’d know the crossover and treatment arm data, which would unblind the trial.
Unblinding will happen in the next few months. The company does deliver on its promises, just not always in a transparent timeline. I believe their veil is warranted.
Yeah...nobody should really get excited about DCVAX until they read the published blended data results. I would expect patients to only be curious until they read the JTM article and the blended data results that exceed published Optune data with no adverse events or the need to carry around a large battery pack and wear a helmet. Maybe the thought of better survival statistics without the need for a helmet or battery pack is the source of patient excitement?
Do you believe that the control data in this trial will exhibit a significant deviation from historical SOC data? Maybe you could expand on your statement?
If the SOC control arm underwhelms, I’d say that makes the data even more compelling. The crossover will be where things get interesting. Can they prove that DCVAX showed efficacy (even for methylated) after progression? That opens up a whole new discussion.
The data read is going to be interesting.
Depending on how tightly management and Bigger hold their shares, the pop after topline could be substantial.
Let’s keep our fingers crossed that the market responds appropriately to data this time. Interim data was brushed under the rug by the market.
After lightning strikes twice with NWBO, you may want to flee the danger. I recommend another cruise.
And yes, the science of DCVAX is solid and the data projects to be groundbreaking.
Those numbers help put it in perspective, but don’t begin to tell the potential here.
The KITE and JUNO valuations are what make valuing a positive P3 trial here tricky. Both were valued at $10-$15 billion, but didn’t have as much potential as a successfully demonstrated DCVAX platform. The question really becomes, what would that be worth? I think the value starts at $20-$25 billion. I think DCVAX-L alone is worth $10-$15 billion after a successful P3 trial. There are going to be all sorts of calls to expand use with no side effects, if efficacy is demonstrated on solid tumors.
I agree.
PFS “events” were listed as completed in Feb 2017. I wonder how many of those “events” turned out to be progression into nothing?
The PFS data could have changed. Wouldn’t it be considered “pioneering” to reconsider PFS data that was completed in Feb 2017?
One of the interesting statements made at the ASM was that opposing financial forces or short sellers may be walking into a trap. I guess we’ll see how big a lie that is when topline is released.
I wonder if LP will buy 4 million more shares this spring?
Feuerstein is probably upset. He can’t attack the words or statements of a company that is hell bent on silence and remaining silent.
Actions speak louder than words. They’re intent to let trial data speak for itself.
Thanks for clarifying. I can only hope to make up for what I lack in reading skills in other areas.
Where did Dr. Rago say NWBO failed its primary endpoint? Are you putting words in his mouth?
Dr Rago’s statement that you quoted was about Avastin only.
No doubt that it is understood that with their history of setting expectations, patience has run thin.
I still can’t bring myself to sell at these levels though.
I keep my identifications to whiskey drinker, amateur home contractor, male, biotech investor, and golfer. While I identify with those groups, I don’t consider myself profoundly good at any tasks associated. Although, on rarest occasions I consider myself best at whiskey drinking. We’ll find out in 2019 how well I do in biotech investing.
They did tell us that there was massive pressure to unblind at ASCO in 2018.
Agreed. No offense Xena and Flip. I should have left the context to whiches.
I don’t identify as a witch or warlock, nor do I have proper understanding of what that entails. I’m sorry I associated it with physicians that may have a hidden conflict of interest behind statements questioning the science behind DCVAX.
Let’s stay positive and open minded regarding the science here. A significant advancement in cancer care shouldn’t be marginalized by opinions swayed by big payments from big pharma.
The overriding theme in medicine...
Which doctors are being paid by which organizations to promote which therapies?
Medicine sure is full of witches...
Hindsight is always 20/20.
I imagine there was enormous investor pressure to unblind in 2017, but the SAB was sharing that unblinding could preclude approval in the basis of tail data, which we all know has been stated by FDA as a consideration in these trials moving forward due to new realizations of how immunotherapy works. So while we can debate for eternity what was said and the inconsistencies in statements from management, we can also agree that this trial has spanned a dynamic period within the regulatory environment where there has been more consideration than ever given to trial metrics other than primary and secondary endpoints.
I think it’s a plausible idea that they aren’t taking any chances with the FDA. I would imagine that the FDA is not seen as a friendly force here, but a well-oiled, big pharma checkpoint. Big pharma would love nothing more than for the FDA to make NWBO repeat the trial because they made a questionable error like handing out too much info. Best for NWBO to stay conservative with its data releases, even at the risk to its current share price.
We have to assume that regulatory oversight is enemy territory. It’s best to stay tight lipped until data analysis plan is approved and we can apply those agreed upon parameters to our dataset.
Could they be keeping these numbers hidden to avoid accusations of providing unblinded data?
Just more cash rolling in to fund us through approval...
Clearly he’s getting paid well, as the stock price reflects Dr. Rago’s amazing Twitter following. Maybe Lincoln will call him next to replace Matthew McConaughey?
I don’t think Dr. Rago’s endorsement was for marketing and promotional purposes. I think his scientific opinion is reasonable and valuable.
Probably because Feuerstein would expose his utter lack of scientific knowledge and his inability to understand the reasonable position that DCVax is quite likely the underlying cause of the unprecedented survival in the P3 trial.
Or maybe a government shutdown interrupted some of this regulatory work?
Well then there will be a few shares to borrow. How many shares do you have Scotty? 10k?
I will be moving my shares into a non margin account tomorrow.
Flipper or other moderators...please link part one of Ike’s ASM notes to the sticky board. The other parts were subsequent replies.
Well done Ike! I love hearing pedal to metal on SAP and unblinding. Maybe by St Patty’s Day or Easter. Or ASCO?!