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Adam, here is some BS-free analysis of your work. You using your bully-pulpit in your writings has 2 insidious effects. You probably know that, but somewhere along the way you sold your soul and thus are able to sleep well at night:
1. The US is probably the only country where there is so much risk-capital going into innovative drug companies. That is why the US is by far the leader in new break-through medical technologies. By passing judgement on clinical trials, where even the sponsor, participants and regulators are blinded (where you couldn't possibly know more than they do), you drive down the stock price and make it more expensive for these companies to raise money to complete their work. This also drives away potential investors who may otherwise take risks because they know that the market is rigged. The ultimate effect is that early stage companies end up spending more than they otherwise have to because all the negative "news" from you from ends up raising the cost of capital. It slows down the trial process and probably contributes to higher drug prices when approved.
2. Secondly, your judgement on drugs still in the clinical trial phase (especially when you don't know more than the sponsors, investigators and regulators) also drives away potential trial participants. The affect: a patient who could have potentially benefited from the treatment probably dies early. Slow enrollment means longer trials and delayed time-to-market where is can potentially benefit thousands more.
Now do you understand where we are coming from when we criticize you?
Hi Senti, I knew this would perk your interest :). Here's my 2 cents on the use of the word "major":
If this was something related to a problem with the phase 3 trial, where the company is playing defense, it would be unusual for NWBO to use the word "major".
If these were submissions relating to Direct trial design, again it would be unusual to use that word.
I'm interpreting it to be something extensive and significant in favor of the company.
Found this little itty bitty thing in the latest 10-K:
Under section on Operating Activities, "The increase in cash used in operating activities was primarily attributable to (lists the normal items, and)....major regulatory submissions".
I looked back the previous 10-Q filings and could not find similar wording.
Not sure what it means? Doesn't the word "major" sound unusual?
Isn't that the guy you are planning to have a conference call with, to discuss immunotherapy? It's going to be a nice bash-fest. I wonder which little biotech is being set up. Wink, wink. :)
90% of start-up biotechs fail. No mystery in that. If you shoot at everything, you will hit 9 out of 10 times. Takes no genius.
Genius lies in picking winners. Your record of picking winners is abominable.
How about some comments on the science?
Pyrr, are you still trying to $hit on us. You are 0-3 so far. That's a strike out. As far as I know, you predicted success of Rintenga. Wish I had the time to go looking for that post. Also DNDN. You were acting like a hero by touting that you were buying DNDN when it was $1.50. And everybody here knows about your debacle with CLBS. What are the odds that you are right about NWBO. Please stop acting like a genius and take your buddy AF with you.
Yeah !!
Oh my ! Silly me.
I disagree. Even mentioning that CLDX's interim analysis is one of eight possible catalysts for a sector rebound is laughable.
On the other hand, I realize AF is the world's greatest biotech expert; so I should give him benefit of doubt :)
Some news of interest:
CheckMate -141, a Pivotal Phase 3 Opdivo (nivolumab) Head and Neck Cancer Trial, Stopped Early
http://finance.yahoo.com/news/checkmate-141-pivotal-phase-3-115900880.html
It would be nice if you could also provide evidence where LP was actually implicated.
That's not going to happen. The FDA is not new to trials which require crossover. Provenge was approved with a placebo crossover upon progression. Corssover impact was more of a concern with Provenge because most patients with prostate cancer typically die of some other cause. But it's not the same with GBM. The historical survival numbers have been well established and crossover impact will be less important. I believe that the FDA will be more focused on the PFS and OS numbers in the treatment arm.
Then why even require a confirmatory trial. If historical control and survival numbers are the benchmark to beat, then we need only to look at the survival numbers in the current treatment arm.
Very interesting. A five-year-old could have come up with a better retort.
That seems like a dodge that you keep accusing Maverick of.
That's amazing, isn't it? 82% vote for Linda isn't mathematically possible without Woodford's support. That should explain everything. No need to debate whether NW thinks he made a mistake.
Most posters here have something on the line, either long or short. But Adam professes to be neither. All this time and effort on this board, nothing to lose, but no substantive statements about the science or the phase III trial. It's the holidays. Yet he chose NWBO to be spending time. Hmmmmmmmm........
Got it TC_Trader ! Evil empires have have a grand time until they collapse. They always do.
Why hasn't Adam been suspended from the Street.com pending investigation into these allegations?
That hypothesis is extremely stupid because patients enrolled are continuing to get their treatment.
Dear Adam, sorry I forgot to remind you.
About the mosaic theory.... Black and white is what everybody knows and the information is in the public domain. The mosaic theory is about connecting the dots on publicly available information. In your vast experience in covering biotech stocks, what are the dots that connect you in predicting a phase III failure? For the time being, let's forget about the Cognate and Linda issues and focus only on the science and the phase III trial.
Thank you so much.
Looking forward to your future article Adam.
But I recall that you have you said that Phase I/II data are poor predictors or eventual success. How do you predict failure in NWBO phase III so far?
Thank you for your response.
Dear Adam, do you have any comments about the science of NWBO?
Also, have you heard about the mosaic theory? There's the mosaic theory and there's black and white.
Thank you for your insights. Happy to have you on the board.
TC_Trader, that's really amazing! There's no honor in threatening one's family. Are these men or pussies ? Profiting from threats to women and children are type that are the lowest of the low.
It's a bumpy ride for slow moving things that cannot run or fly :)
Of course, and understood. Thank you. The comment on enrollment seems to indicate that might be the trigger for news. Also, the push back on data to end 2016 implies that patients are living longer. That's my speculation of course. Am I wrong? (general question for board).
Linda, please give me full enrollment for Chritmas. I will love you for ever.
I guess that means we will get FDA opinion once we have full enrollment. Seems to me like that is the "condition" for an opinion. Thanks for the update.
Don't we already have a wolf on our board ? :)
Lots of very good discussions here on the PhaseFive report. Wanted to share my musings too:
It’s a 60-page report, but only the first 22 pages are worth focusing on. The sections on internet bloggers supposedly being paid by NWBO to promote the stock and recruit people for trials, manufacturing facility in the UK, and the science (which even a science-dummy like me can see is utterly contrived) are at best the worst kind of speculation and at worst, utter nonsense.
I’ll comment a bit on those sections that may be cause for legitimate concern. The payment of $5 million to Navid Malik does raise serious issues of integrity and corporate governance. As somebody speculated, it’s quite possible that Linda and NW were hooked-up by Malik. After all, he is a star bio-tech analyst in Europe and NW being a prominent healthcare investor are very likely to be familiar with each other. In that sense, yes, it’s possible that Malik might have arranged financing for Toucan/Cognate in 2012 for which he might have been paid. Which investment banking house on Wall Street does not write favorable research reports on companies that use them for financing? Moreover, if this was a shady deal between Linda and Malik, why would it be on the public domain for Phase Five to discover? It could be an ethical issue between his then-employer and Malik, and Malik being a NWBO director should raise concerns for us. I think this is why he has been suspended (with pay) by his current employer until details can be sorted out.
The points regarding the Conversion Price Agreement and payments to Cognate for manufacturing services are fair questions to ask. I have pointed out before that external audits (which NWBO is subject to as a public company) must and do look into related-party transactions to ensure that they are at arms-length. Nevertheless, I’m glad that we now have Elliott Leary who will for sure also dig into these transactions. I agree that this is a good development for us and is in NWBO’s best interests given Linda’s conflicting interest in Cognate. Elliott will for sure tighten corporate governance. By the way, I’ll point out again that the accumulated losses of NWBO are less than half of what Dendreon accumulated at the same stage of development (Pyrr and I have dueled over this).
As for the questions on patents, I’m just wondering, would NW have looked into the science and clinical trial developments as part of his due diligence? I’m sure he did. Would he have known about Linda’s relationship to Cognate/Toucan as part of his due diligence? I’m sure he did. Given Linda’s relationship to Cognate, and NWBO being a clinical stage company, as part of his due diligence, would he have made sure that the patents were in the right hands? What do you guys think?
One final thought. NW did not choose an individual. He chose a firm. Why didn’t he just go to an audit firm or a law firm to dig into these allegations? Why do you need former FBI agents for this? I believe NW and Linda have already spoken at length about these allegations. I believe his motives are two-fold: he wants to get to the bottom of the related-party transactions and the payment to Malik. Then he also wants to get to the bottom of who are the individuals behind these allegations and their motivations. This second part will require former FBI-agents and the favors they can call in to their current FBI pals in order to use the vast surveillance and tracking resources of the FBI (okay, this last part is wishful thinking, but I hope it’s true).
Then you should convince your sister to sell too. If your convictions are so strong, then you are failing your sister. If she is not convinced with your argument to sell, perhaps she can follow this board rather than you.
Really? You would loan your money to NWBO for warrants? How much are they going to be worth if phase III and Direct fail as you keep claiming?
If you were long, you would have claimed that Les, as an insider, cannot buy in the open market if there are pending material developments.
Here's another quote from Voltaire:
"We must distinguish between speaking to deceive and being silent to be reserved".
I do love Voltaire. He was my go-to philosopher during my college days :)
Apologies of this was already posted.
10-Q, page 18.
This is the key statement:
The Company has adopted a policy of recognizing these payments as revenue when received. As opposed to accruing revenues. This is why we don't see revenues from HE in the 10-Q.
The quarterly filings at least for the past year have also stated that operating costs include costs related to early access programs in Europe.
Also, someone on this board had emailed PEI last week and received a response acknowledging that HE for L is alive and well and available to patients. Agreed that this has not been validated.
So, the question is why haven't we received payment yet? This is just my guess: NWBO probably asked for a price in line with other similar treatments and the German hospitals have balked, probably saying that this is not yet an approved treatment. Maybe they have reached an agreement to wait till there are definitive results from the phase III. It's a risk that LP is taking. But she is probably also concerned that any pricing established in Europe may impact US pricing. In the end she may not get paid at all if the trial fails. But the fact that she is willing to wait (which is a big risk and she could use the money now even if the payment is lower) makes me believe that she must be very very confident in the outcome. JMHO.
Hi Lunatick, sorry I did not see your earlier question. Please see my post 41791, which I think may answer it. I'm copy and pasting here:
From 10-K as of Dec 31, 2014, financial statement footnotes, section on "Revenue Recognition"
Quote:
The Company recognizes revenue in accordance with the terms stipulated under the patient service contract. In various situations, the Company receives certain payments for DCVax®-L for patient treatment. These payments are non-refundable, and are not dependent on the Company’s ongoing future performance. The Company has adopted a policy of recognizing these payments as revenue when received.
From 10-Q as of June 30, 2015, section on "Operating costs":
Quote:
Our operating costs also include the costs of preparations for the expansion of our clinical trial programs including the Phase III trial in the US, UK, Germany and Canada (with DCVax-L for brain cancer), early access programs in Europe,
The fact that revenue from HE has not showed up in their income statement bothered me a bit. But a little research on the above confirms the following: costs related to HE have already been recognized in the income statement every quarter. However, since revenue recognition policy states that revenues will be recognized in the income statement only when received (as opposed to accrued), these revenues will show up in the income statement once reimbursement (assuming price of treatment is the unknown variable) is finalized - supporting your view.
Moreover, the above confirms for me that HE costs ARE being incurred (meaning there are patients being treated), and these revenues will be recognized when payment is received.
And what you are leaving out is that the total enrollment for both of DNDN's 2 trials was less than 348. And the length of time in development is fairly similar with both companies. With regards to manufacturing, I would rather that it is outsourced at this stage of development so that NWBO shareholders are not on the hook for plant and equipment. It's a sensible decision even it means paying a bit extra for services.
NWBO just needs enough manufacturing capacity to begin commercialization. Then we gradually scale up capacity to meet demand. It would be stupid to set up manufacturing to meet peak demand when it's still not approved. By the way, Dendreon's 3 plants cost about $150M. You take that out of the equation and it's still a huge difference.
Let's do an apples-to-apples comparison:
Provenge was approved on 4/29/2010. So I chose their 10K as of 12/31/2010, because it took them more than 6 months to complete manufacturing facilities and reach commercialization.
Dendreon accumulated losses: ($1,222,934,000). Add to this the change in their plant and equipment (since they built their own manuf. facilities) in 2010, which is about $150,000,000. This gives us a total spend of $1,372,934,000.
NWBO's accumulated losses as of 6/30/2015: ($633,799,000). Plant and equipment not relevant since we are paying Cognate to do this.
Bottom-line, NWBO is under-spending Dendreon by $739,135,000. Even if you impute that NWBO is about a year from commercialization, that's still a huge under-spend.
Also, remember Dendreon was (1) a one-trick-pony; it was Provenge or bust, and (2) they had no ex-US activities. NWBO is also doing Direct and heavily invested in Europe.
You need to check out how much Dendreon spent and you may be pleasantly surprised how much lower are NWBO's costs.