The following is an excerpt from Smith on Stocks dated 2/19/13, and for the record this new deal with Cognate is not NEW, it is a continuation of a deal put in place by Cognate hoping to get back SOME of the MILLIONS they had spent keeping NWBO out of BK. Cognate FOR all there HELP to NWBO has been granted favored nation status and as an affiliate of NWBO will always be such.
There seems to be a clear implication that insider dealings have benefitted Ms
Powers at the expense of shareholders. I have gone over her financial dealings with the company in considerable detail in my July 19, 2012 report and also in my January 14, 2013 report. The bottom line is quite the opposite of this implication of benefit to Ms. Powers. Without the capital Toucan invested and without Cognate having continued to manufacture for NWBO for several years without being paid, which no unrelated party would have done, NWBO would no longer exist today. NWBO was not able to finance through the capital markets until very recently because of the weak financial position of the company and the skepticism of the investment community about immunotherapy.
Ms. Powers, certain non-traditional investors and Cognate were the only sources of capital available. I might add that all of the investments of Ms. Powers and her affiliated funds were made at or above the prices of other investors, and nearly all were at higher than today’s price. In regard to Cognate
BioServices, this is a company owned by Ms. Powers and her funds. It continued to manufacture product for NWBO’s clinical trials even though NWBO was unable to pay them; as a result, NWBO accrued significant liabilities to Cognate. The bottom line is that without the investments of Ms. Powers and the support of Cognate, NWBO would almost certainly have failed. She now owns or controls about 40% of the outstanding stock. If you are looking for CEOs with skin in the game, she has to be at the top of the list.
This 4.00 per share was agreed on a while ago, this is not a new negotiation just the finalization and carry forward of an existing deal. Think of it this way COGNATE carried nwbo FOR FREE when NWBO was in the pennies before the RS, doing work on a iou basis, this is a fair equitable deal. Cognate could have wiped out ALL equity in court but DID NOT because cognate and NWBO are owned by powers.
This news was released in April, and the final contracts drawn up now, it is not news. NWBO owed cognate OVER 11 million for services not too long ago, and if Cognate tried to collect it would have put NWBO into BK. SOOOO, and BUTTTT, Cognate because of POWERS let NWBO ride and ride and ride and eventually Cognate TOOK the 11 million in stock. WELL NWBO can use cash, NOT, issue shares in the OPEN market, NOT, or pay with RESTRICTED shares for future services until they either 1.) get FDA approval, 2.) sell the company
3.) Close their doors, now if it is DOOR three Cognate is out millions and will likely be forced into BK too. Powers will be out a ton too.
As a RULE phase 1 or two do not need a control arm so Feuerstein was postinginfo to support his point.
Phase I/II trials are by definition, single arm, non-randomized studies and the graph clearly states that this data is from a phase I/II trial; this is clinical trials 101.
His real beef was that NWBO showed a P .0003, because they compared their data to the matched group, A COMMON PRACTICE, but a matched group is not a control. That said, it is the MATCHED COMPARISON P .0003 that goes to the FDA, and based on that NWBO was granted phase 3 status. A P .05 gets approved, a P .0003 is off the chart, so I understand his skepticism. ICPT who had their study halted were P .0024, NWBO showing P .0003 but with only 20 subjects was his issue.
While Feuerstein was bashing NWBO, and clearly showing his lack of knowledge on what is accepted norm in research, he was praising IMUC and their approach and their study.
Should have No affect at all. This was all discussed at length several times during the year and known to the market.
Why would it make it harder to demonstrate 6 month PFS between control and treatment arms. If the third arm ( patients ) get randomized into the two groups the negative effect gets balanced. That third arm if I am understanding it right might already have tumor regrowth and No treatment could help. All this said, it will come down to the % of those patients in the study, if that % is small the size of the study should negate it. Even in the FIRST NWBO study they had patients that did not live a month, unfortunately in a random study you can not pick and choose. I would like a 4th arm, no radiation or chemo, just DC VAX, no way to know if the chemo, radiation is minimizing or maximizing DC VAX without that arm.
I copied and pasted, but thanks, lol. Smith did all the work, I did give him credit, no Copy rite suits here.
So talk about a low bar, yes NWBO phase three does not need to duplicate that 17 month survival benefit, but only a 6 month benefit. In the initial study 13 of 20 reached 24 months, so it looks promising.
NWBO’s product lines have broader applicability to diverse cancers than IMUC’s products. NWBO’s DCVax-L is applicable to all solid tumor cancers that can be surgically resected. NWBO’s DCVax-Direct is applicable to all solid tumor cancers that are inoperable – and FDA has approved it that broadly for trials. IMUC’s products hopefully will eventually be shown to apply to several cancers, but as of now, IMUC’s ICT-107 is only applicable to brain cancer and ICT-140 is only applicable to ovarian cancer. IMUC’s ICT-121 targeting a single biomarker believed to be on cancer stem cells may eventually be applicable to many cancers but that is unclear as of now.
11. NWBO is positioned to be able to apply for product approval in both the US and Europe, while IMUC is only positioned in the US. NWBO is not only conducting its phase III trial in Europe, it has also established a manufacturing capability in Germany and the UK, a process that took more than two years, while IMUC is manufacturing only in the US.
In view of the above factors, I find it difficult to understand why Mr. Feuerstein is open-minded about IMUC as a company and close-minded about NWBO.
. NWBO’s current 312 patient phase III trial is nearly three times the size of IMUC’s current 124 patient phase II trial. There is a widespread misconception about the patient size of the IMUC’s current trial. Because ICT-107 only works in a certain immune type (HLA A1 and A2 positive) it is not applicable to the entire glioblastoma population. In the phase I/II trial of ICT-107, the company screened 278 patients, but only 124 patients were randomized and enrolled in the trial. Over 50% of patients screened were excluded, primarily because of the immune typing issue. Some investors have not understood that this is a 124 patient trial, not 278 patients.
5. NWBO’s phase III trial has a better chance of reaching statistical significance because it is so much larger. The size of IMUC’s trial (number of patients) is relatively small in relation to the anticipated difference in treatment outcome (6 months of additional survival), and may be underpowered.
6. NWBO’s trial has been approved as a Phase III trial by two different regulators: the US FDA and UK MHRA. IMUC’s trial has only been approved as a phase II trial by one regulator (the FDA).
7. NWBO has extensive collaborations with large marquee partners in both the US and Europe, which provides significant third party validation. There is no such validation for IMUC’s technology.
8. NWBO has completed phase I/II trials in two other cancers besides brain cancer (prostate and ovarian) cancers, and both of these trials had encouraging or striking results. IMUC has not conducted any other clinical trials with any other product besides the one 16-patient Phase I trial in brain cancer with ICT 107.
9. NWBO has received more regulatory approvals for more and larger trials than IMUC. NWBO received an extraordinary scope of approval from FDA for its first-in-man, combined phase I and II trial of its DCVax-Direct product for direct injection of dendritic cell precursors into any type of solid tumor that is inoperable. This
First, it is likewise relatively rare for an experimental cancer treatment to show such a large difference in clinical outcome (such a large extension of survival) as DCVax-L showed in NWBO’s Phase I/II trials. In metastatic disease, improvement of 4.0 months in median overall survival is considered quite good. DCVax-L showed a 17.0 month or more improvement
Second, the fact that the time to tumor recurrence and overall survival time were both extended in patients treated with DCVax-L provides some added comfort about the clinical effects seen. Third, other parties have done some work that provides some corroboration. Dr. Keith Black, who is now associated with IMUC, conducted a clinical trial at Cedars Sinai with essentially a copy of DCVax-L, and obtained largely the same clinical results as shown in NWBO’s phase I /II trials. Those results were published.
NWBO has been conservative on this critical point in their phase III trial design: they have designed the trial so that to satisfy the primary endpoint, the results only have to be 1/3 as good as the results in NWBO’s Phase I/II trials i.e., a 6-month extension of progression free survival, rather than an 17-month or more extension as was seen in the Phase I/II trials as compared with standard of care.
NWBO has also built at least two further important protections into their Phase III trial design. First, NWBO has powered the trial for the secondary endpoint of overall survival in addition to the primary endpoint of progression free survival. Second, NWBO has built in an interim analysis for size of the trial in addition to two interim analyses for efficacy. This allows NWBO to increase the trial size if needed in order to have sufficient powering.
In the first place, phase I/II trials are by definition, single arm, non-randomized studies and the graph clearly states that this data is from a phase I/II trial; this is clinical trials 101. In addition, the slide specifically states that the red line is “matched patients” treated at the same hospital with the same standard of care. The term matched patients also has a standard meaning. It means that these are patients who were not in the clinical trial but who have similar characteristics as the patients who were in the trial (comparable concomitant treatment, age, gender, physical condition, etc.); this is also clinical trials 101.
: The 20 patients who received DCVax-L plus standard of care had a median overall survival of 36.4 months while the data for the 119 matched patients show a median overall survival of 17.0 months. Based on these data sets, there is indeed a 19.4 month difference in median overall survival favoring DCVax-L.
Note that the survival benefit favoring DCVax-L may be even greater than 19.4 months (it could actually be represented as 22.2 months) if the DCVax-L data are compared to the “official” figure on median survival that was achieved in the pivotal clinical trial which formed the basis for regulatory approval of what is now the standard of care for GBM.
these data have been reviewed and accepted by both the FDA and the UK’s MHRA (the UK equivalent of FDA), as well as multiple major partners of NWBO, the German government, and investigators and IRBs at 41 clinical trial sites.
Mr. Feuerstein also overlooks the fact that, regardless of whether NWBO’s phase I/II trial patients lived more than twice as long as a group of matched patients, they lived even more than twice as long compared with the “official” survival data from the 573-patient Stupp trial, as explained above.
I am long NWBO, but one concern is that NWBO does not own Cognate outright, but they are joined at the hip anyway. The fact they are separate allows NWBO to keep issuing shares to keep Cognate running. This in turn allows the research by NWBO to go forward, not the best situation, but it is what it is. NWBO owed Cognate over 11 million and converted that debt to shares, 18 month lock up, back in July, From a SA article by McCuster:
he Bottom Line: A good but, deal … for the balance sheet but, maybe not the dilutionary affect. Cognate has provided manufacturing and regulatory assistance to NW Bio in the US since 2004, in Israel since 2008 and in Europe since 2010. Interesting … Cognate shares common ownership with NW Bio (by Toucan Capital), and as such is an affiliate of NW Bio under the securities laws. NWBO reduces its cash burn while building its operations in Europe as well as the US; while pursuing 2 major clinical programs (both DCVax-L and DCVax-Direct) simultaneously.
Not necessarily. Linda Powers and Tucan partners own all or near all of Cognate. She is also the largest shareholder of NWBO. If Cognate were a public company shareholders would be up in arms due to this conflict. As the major owner of Cognate she simply worked out a payment deal with the ceo of NWBO, herself. No way for us to know if she is over paying or underpaying, but it is a deal designed to benefit both Cognate and NWBO. Cognate has been on shaky financial ground in the past and NWBO is one of their major clients, so the life of NWBO is tied to Cognates future too.
U are bordering on a comedic act, like when Archie Bunker told the Dr. give me Edith's blood for the transfusion. We eat the same food, the blood has to be the SAME.
Your comedy is that you KNOW for a fact NWBO's designs are inferior to IMUC, you rant as if they are the same product, and are banking that NWBO's phase 3/ and phase 1/2 both will have similar results to imuc. That is a lot of secrete knowledge, LMAO.
The fact is both DESIGNS were APPROVED by the FDA, and NWBO does not use a MAN MADE molecule. Imuc failed = Nwbo will fail = buy a mutual fund.
This here is likely the most meaningful thread posted in months and has been pushed back X pages. Not sure it even gets back to the top, but I am going to try. What is going on in England could be BIG BIG for 4k, prostate testing, and OPKO. OF course it is up to the British help department's Nat insurance, so time will tell.
This was mentioned a few times this year and was not a surprise to anyone. Without this arrangement NWBO would have gone belly up a long time ago. To pay with shares to manufacture the drugs needed for the phase studies, and eventual FDA approval is minor in the big picture. It is to this manufacturers advantage that NWBO succeed so our interests are aligned. Cash has to managed carefully to get to the end of the phase studies, period, a few million shares to make that happen, no big deal.
Found it interesting that COGNATE had to for some periods of time go to 7 days a week work schedules, and OVER time scheduling to help with the phase studies.
Interview with Powers from June 18, 2010 on why putting off Prostate cancer study.
Q: Why did you give up on prostrate when it has a larger financial potential? Why not focus here instead of on the brain cancer?
NWBO's Linda Powers: It’s purely a function of dollars and time. The dollars to conduct the prostrate trial phase 3 is 35 to 40 mil, for brain, it’s 10 to 15 million which is an utterly different scale of resources to come up with. And, because brain cancer kills so fast, unfortunately, the trial and path to product approval is years and years shorter. The third reason why is that people underestimate what is the market potential of brain cancer. There are two types of brain cancer. There’s primary brain cancer, meaning that it starts in the brain and when it does it stays in your brain, it doesn’t travel anywhere else in your body. Then there’s metastatic brain cancer, meaning it started somewhere else – breast, lung, colon, etc – and ultimately metastasized to the brain, which is what kills patients. Even if you just take the primary brain cancer, and you figure just a modest percentage of patients getting the treatment – 10%, 20% of primary brain cancer, you’re still into blockbuster sales territory. People don’t realize that. You’re well in excess of a billion dollars in sales.
Yes dated but there is one hidden gem in that info. Opko sold off their ophthalmology holdings for the most part. Yet why would Frost ask Biozone for exclusivity for ophthalmology use of Qusomes?
Back when Opko was new they had a phase two study for a pink eye med, it never progressed beyond phase 2. Not sure but it is a possibility Frost thinks that study can be dusted off incorporating Qusomes? Maybe, maybe not, but that pink eye med and the phase two after years of absence appears to be in the Mexican facility. So if not that drug, Frost might have other patents to use it with.
BUY, hold, I have been in opko since 2011, SO I HOLD, lol.