Nwbo could have determined whether the indeterminates were rapid or pseudo. One more scan would have done it At that point all patients would be definiitively diagnosed. Not faulting them, after all it is just an info arm. Still you have to wonder. Btw Linda was taking liberties with her " sickest of the sick" comment. Pseudo progressor median is higher than it is for those who are SD or PR at first scan.
well donkey, that is just dead wrong. The manufacturing process has been amend several times and the changes approved by the FDA. That being said, approved or not, it is yet another reason why the FDA is limey to require a second trial even if the results are good
Here ya go --enjoy your crow THESDA, MD, September 10, 2013 — Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that it has been issued another key U.S. patent (#8,518,636) covering a next generation process for manufacturing lower cost human dendritic cells of both a higher quality and higher reliability.
This next generation system has already been cleared by FDA for use in the manufacturing for NW Bio’s clinical trials. These systems are now in use producing the vaccines which already have been injected into the tumors of DCVax-Direct patients.
This next generation process automates certain crucial stages of the manufacturing process within a self-contained, system. Automating some or all of the production process within such a system can eliminate the need for today’s extremely expensive “GMP” clean rooms (with, for example, special air handling to maintain sterile air in an entire building). Eliminating the special costs for such clean rooms will further enhance product economics, allowing wider margins and pricing flexibility.
At the heart of this next generation manufacturing advance are Tangential Flow Filtration machines, or TFF for short. These machines and associated disposable sets provide an automated, closed system for the crucial stages of the manufacturing process isolating the particular immune cells that become the dendritic cells in the Company’s DCVax products.
Most significantly, the dendritic cells produced through this next generation system, are manufactured using procedures which are more closely related to what one finds in nature. etc.
What link do you want? Google UCLA GBM database and the same for Cedar Sinai. There are a couple other sources but you can find them if you care, You will need to fiddle with the numbers a bit to conform to the NWBO trial parameters in order to compare apples to apples. I already did it for you but hey why would you believe me? As for PFS being a satisfactory endpoint, I refer you NWBO's own 10-q.
The trial has serious issues. Even if the data looks good, the FDA may require a mulligan and I assure you they will look right through PFS if OS is not increased. This trial is over 10 years old and has been subject to multiple delays, missed deadlines and trial revisions with a very suspect end point (a complete mystery to me as to why they chose PFS) They have some titillating data and may have some more which will move the stock but they are a loooong way from approval on either continent.
Pretty simple. You signed an hypothecation agreement when you opened the account , which gives E-trade the right to use your shares as collateral. You still own them. The agreement is valid even if you are not currently borrowing money on your margin account, in part because you still retain the right to borrow against the collateral. The fact that you aren't currently using that right is irrelevant. Nothing particularly complex about it.
you're wrong on the "double" see Patriot's post if you want to be informed. Or go to NWBO's website and READ. But like all here you don't really understand the numbers. If you did you would have some concerns. For instance, the 5 excluded patients didn't vanish, NWBO just didn't count them. But we know what happened to them. Of the five patients that were excluded, 3 died well before 10 months. If (as is likely) they were in fact "rapid progressors' and added to the N of the rapid progressors, the median would be somewhere around 13 months and if N was just one or two more and died in less than 10 months, the median would be 10 months. Just saying.
As for the "indeterminate".group, well there is no medical classification of "indeterminate" The fact that you didn't "determine" them is meaningless. They were, as a matter of empirical fact, either rapid or pseudo.. There were probably a few true rapid progressors but the majority would be Pseudo., since somewhere between 35 and 50% of rapid progressors turn out to be pseudo. If you assume the second groups is 100% pseudo, 21.5 months ain't good news. In fact it is lower than at least one study, of pseudo that had median OS at 24 months. A second study had OS at about 19 months.
If you really wanted to make a more accurate estimate, you would assume that a few of the 25 indeterminate are true rapid progress ors say 4 or 5. It would also be fair to assume they died pretty early. 8 indeterminates died before 14.6 months. If you assumed that most in not all of the 8 were true rapid progress ors ( a reasonable assumption given the disparity between the OS's of the 2 groups 8-10 for rapid and 19-24 for pseudo) and you removed them from indeterminate and placed them in "rapid", the OS for rapid plummets. The OS for the pseudo improves but only to about 21--right in line with historical OS for pseudo progressors
All in all the data is not compelling and is, in fact , troubling.
The sign of a dimwit is to reject anything that does not comport with his preconceived notions. Mindless cheerleaders do more damage to you that informed skeptics. Good luck.
Just a bit of science to beak up the tedious stream of banal, useless, infantile drivel on this board.
Pseudoprogression was observed in 10 (12%) cases applying the stringent criteria, and in 18 (23%) patients when using the liberal criteria, in the cohort treated with RT/TMZ. Pseudoprogression was observed in only one patient treated with RT alone. The median time to pseudoprogression was 4 weeks after the end of RT. Patients with pseudoprogression had a median survival time of 28 months, compared with 12 months for patients without pseudoprogression
One more UFC cyber head smash while you are on the ground, and I'll leave you to soak in your humiliation- -- From their most recent prospectus
Changes in manufacturing methods for DCVax-L could require us to conduct equivalency studies and/or additional clinical trials. -With biologics products, “the process is the product”: i.e., the manufacturing process is considered to be as integral to the product as is the composition of the product itself. If any changes are made in the manufacturing process, and such changes are considered material by the regulatory authorities, the company sponsor may be required to conduct equivalency studies to show that the product is equivalent under the changed manufacturing processes as under the original manufacturing processes, and/or the company sponsor may be required to conduct additional clinical trials. Our manufacturing processes have undergone "some" ( I would say "some" should read "substantial" but at least one of which is the time they mature the DC's donk) changes during the early clinical trials. Accordingly, we may be required to conduct equivalency studies, and/or additional clinical trials, before we can obtain product approval, unless the regulatory authorities are satisfied that the changes in processes do not affect the quality, efficacy or safety of the product.
What you seem to ignore or simply don't know is that in all pharma, but especially biotech the CGMP process is as important and as hard or harder to obtain as a good clinical result. In fact donkey the pioneer of DC technology used to get his DC's for free from a local blood bank, but the FDA stepped in and said they needed to ensure the quality and put a stop to it. His comment t the time was that there would NEVER be a DC drug because the cost of getting fda approval for the mfg would be prohibitively high. Dendreon ultimately proved him wrong--or did it? Enjoying your crow yet?
Sorry. The control group will live about 20 months. Take it to the bank. Stupps study was done io 2005. It is disingenuous to continue to quote 14.7 months. There is plenty 'o' data out there. Not saying DC-Vax won't work just that you should expect control to be 20 months.
Bob. Not many here want to do the research or critically examine the "results" At this point I am agnostic on whether DC-VAX works. I could critique the results reported so far and may do so in the future since I've already done the work and there is plenty to critique. But this much remains clear, If you look at the current data, OS is going to be longer than 14.7 months in the control group. If you believe the data bases at several large cancer hospitals it looks like 20-21 months for SOC. If you are making an investment decision using 14.7 months you are in for a rude shock. Good luck. The dude who think PFS is gonna hack it with the FDA is also ignoring reality. If you are interested, I point you the NWBO's comments on the matter in their 10-q's.
I was very fortunate and made about 20k on a long trade and got out at the interday high over 10. Thought about getting in around 5 but passed (my loss) I am currently on the sidelines and my next play (if any) will be with options.. Black-Scholes does not work for binary events so the option are mispriced. This is true as long as there is binary event that moves the stock suddenly in either direction.
If you think OS is irrelevant I have a bridge to sell you. And if OS is 20 months, PFS will be extended as by 4-6 months as well. Hey believe what you want but the info is out there. Maybe you should try a little research.
Don't know what SCO is. But let's start with your own numbers both of which exceed 14.7. So I assume we can at least agree on that. If the number is 16.7 then to achieve stat sig you will need median OS to be at least 22 months or so. But if you look at some other data bases (like UCLA's) then SOC for all GBM patients under age 70 is about 620 days from diagnosis. You can do the rest of the math. Cedar Sinai's is 16.7 months but includes 17% of patients over the age of 70 who have a much lower life expectancy and are excluded from NWBO's p3. If you pull out patients over 70 in the cedar Sinai's data base, the median OS for SOC is about 19 months. My only point friend is this---don't do your math based on 14.7. That is one piece of sound advice.
Yahoo's mkt cap is off by 250- 300mm. Fully diluted share count today is about 100mm and growing daily. At least do your math based on an accurate share count.
PS you are never allowed to use the word "statistically" again since you are clueless on the subject
huuuuuh? Yes you could have a new lesion in which case your "double" is nominally correct As long as you're imagining things why stop at one? Could be a quadruple. But of course it's all in your imagination since you have no breakdown of how many were second lesion vs 25% growth. But is it s a fact that 25% growth twice - is not a double. Depending on how the 25% growth was calculated It's either 50%.or 56.25% of the baseline scan.
And for a second time for the short bus crowd, you cannot determine, from the way NWBO wrote the poster whether the 25% increase on the second scan is measured from the baseline or the first post op scan. I know you don't understand the ambiguity but it is there.
Didn't change the data. As a matter of empirical fact, it is NWBO who altered the data by excluding people from their results. Don't bother telling me that they couldn't include them, but that is the point. You CAN include them and make reasoned estimates about them. Well not you, but some folks.