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I give you a new theory. The temp suspension of screening could be a protocol change. During their negotiation with German reimbursement funds they found it was rather stupid to spread 11 injections to 3 years meaning they could only recover all revenue by the third year and if the patient's tumor comes back earlier before the last dose they may lose 11k per injection.
And certain threads from some tumor fighting forums hinted that now they use one month one injection schedule. They may have been trying this method for some time in the UCLA setting or UK companionate setting. So if they have some evidence now both injection schedules work the same, it's natural to change the main protocol again, causing a temp suspension of the screen.
Yes, the above is one of my nine new theories at the moment. It is useless to have so many theories though.
Unless the company already scored a partner in Japan(usually a native japan pharma), this theory will not hold up.
Japan is a different animal. I have never seen any startup company could do a standalone clinical trial in Japan. Language is the first barrier and culture is the utmost barrier.
For patents granting, as long as you have enough money, that is a non-issue. But working with the Japanese Ministry of Health & Welfare alone? No
The only non-English speaking country NWBO has a trial in is Germany where the company has had a branch since 2012.
"Now I think I know why the NWBO- UPENN collaboration on Ovarian cancer evaporated. "
Or maybe NWBO just did not have enough money to proceed to a P2 trial as the P1 ended somewhat in 2009. At that time, the company had to stop the GBM trial for 2 years.
"I'm assuming if there was some significant results it would have been published but just as I expected that dc vaccines by itself will have a limited response using Recist criteria for measuring ORR he probably found that to be true as well. "
And here is the paper, http://www.ncbi.nlm.nih.gov/pubmed/23482679
George coukos is the senoir author. Apparently you spent too much time on this board spinning what you believe than search for easy accurate information at hand.
1. Deep in the money options tend to have little premium if any. I recall one month earlier there's a premium of less than 10 cents. Now 28 cents? Good.
2. Shorts who fail to borrow shares or can't afford interests sell calls as a means to short. This way they collect premiums (in this case .28) instead of paying someone else put premiums ($1.95).
3. When you think of it, you will also understand this kind of low premium options actually attract stock owners to sell their stocks and roll into the options, effectively helping shorts gain access to hard-to-borrow shares.
4. Most option traders employ complex strategies which make it hard to understand their strategies... The one who sold your options could be run-of-the-mill computer programs who never understand catalysts before us.
5. NWBOW has a much higher premium which expires 11 months later. Unless there is a too complex and laser acute conspiracy against Jan 2017 call buyers while sparing NWBOW holders, I attribute this phenomenon to computer strategy and inefficient market. And the discrepancy between NWBOW and Jan 2017 calls? I attribute it to shorts.
For the 1st P1
Flipper,
I think they still only have 43 progression data. 19 are true rapid progressors and another 8 are true rapid progressors who received another surgery upon recurrence. The remaining 16 are either true or potential progressors they could not distinguish.
Dr. Bosch once gave a presentation in Cornell University on June 7, 2013 and provided the following slide.
And probably because of "Intra-tumoral injection is best preceded by some form of other cytoreductive therapy", the Direct trial employed radiation therapy for all participants. I guess in the future, chemo use will be reduced. And radiation is not that toxic as it is only a local treatment not systematic.
Actually Dr. Linda Liau, Dr. Robert Prins once published a paper in New England Journal of Medicine describing one patient in the previous P1 trial developed a robust CD8+ T-cell response to the pp65 immunodominant epitope of human cytomegalovirus (CMV).
www.nejm.org/doi/full/10.1056/NEJMc0804818
The problem with Duke's approach is patients must have CMV infected their tumors in the first place. So how many patients have that infection in place is a huge question.
So how good are the results from Dr. Marnix's abstract?
For the 1st group, historical data suggests 8 to 10 months OS. So DC-L has 5 to 7 months advantage. For such an aggressive disease, the data is spectacular. And it seemed DC-L created at least one long time survivor (31 months) on this intractable disease.
May I help you jump back in the game by pointing out that Jan 2017 5$ call is trading at $3.58, compared to thinly traded NWBOW at $5 which is only 11 months longer. And almost no time premium. And by Jan 2017, we should know the binary results of Direct P2, L P3 and a lot of other stuffs. So I believe these leaps provide almost the same upside exposure as if you had never sold your stocks in the $5s with the same amount of money.
Of course, holding options is more dangerous than stocks. You need to be astute and vigilant and understand the pros and cons of the game.
MoneyFrog, I can assure you most cancer treatments out there will do some benefits like 3 or 4 months to the patients then creating a much more difficult to treat patient. That's the beauty of cancer drug Big Pharmas all love.
Colorectal cancer is not out of the question yet, I believe. And because NWBO hasn't finished the fully automated manufacturing procedure, it may be wise to leave those bigger indications to the future as changing manufacturing could lead to another confirmatory trial or even revoke hard-earned approvals.
Neil Woodford SC13G finally arrived!
http://www.sec.gov/Archives/edgar/data/1072379/000121390015001367/sc13g0215woodford_north.htm
6,763,050 shares of Common Stock
Maybe shorters could beg him for ammunition?
Long, I agree with most of your comments except I think NWBO could share data with a BP right now without waiting for the ASCO. Direct is an open label trial. The company has data on hand. And NDAs are the first step of any negotiating bwtween the two companies.
There may be a simpler explain. When they designed the trial 10 years ago, they hadn't expected enrollment to be so hard that drew out the trial for years longer than anticipation. 110/240 seemed good at that time if they could finish enrollment in 18 or 24 months.
When they had to re-design the trial on the new 4 month difference ground, if 110/240 ratio left unchanged, they may run into a troubling situation of reaching the final interim test before full enrollment. So adding more events is an easy way to solve that predicament.
Thanks, I have not thought this way.
It is so interesting to learn something new everyday.
My two cents about upcoming Phase II trials will be:
1. colon
2. sarcoma
3. pancreatic
Colon is their plan A for a long time. So no change I guess.
Sarcoma is an orphan indication which almost guarantees a rapid approval if the results are very promising. I hope one middle-size phase II trial may be enough for this hopeless disease. But colon and pancreatic may require at least two phase II trials each. So one orphan cancer and one more common one may be good for the business. Of course, pancreatic cancer can incite more interest. So that's my guess of the moment.
Thanks, trully amazing.
DNDN cut its manufactoring costs more than 50% during these years. Of course, that doesn't prevent it from filing chapter 11.
I think batch buy for equipments and chemicals, higher facility utilization, less human hour per dose, less energy comsuption per dose, less land rent per dose, less SG&A per dose (not counted as COGS though), etc. etc. etc. will all chime in down the volume production road.
And if DNDN could achieve manufactoring effience, so could NWBO.
Response means 25% shrinkage of the remaining tumor. Those patients are re-GBMs or subtotally operated patients not even eligible in the phase III DCVAX-L trial.
And 4 out 14 means 29% response rate which is better, at least on the paper, than Merck's block-busting keytruda with a 24% response rate.
And I believe DC-L also benefited many patients who didn't "respond" e.g. makeing those patients disease stable for a period of two months, etc.
From Imperial college doctors who preside DCVAX-L trial, under section "DCVax®-L phase III clinical trial"
https://www.landesbioscience.com/article/29276/full_text/#load/publications/text-22/ref-R53
Pyrr,
The quick answer to your question about why the company hasn't reported how many patients are real progressors and how many are pseudo is the company itself probably doesn't know the answer either.
Modern imaging technology is limited. So at baseline, if a patient shows progression, the protocol requires one more month chemo and a second visit. And if the patient's progression resolves at the second visit, that patient will be enrolled in the main cohort, as I understand it.
Have we discussed NeoStem's Phase III DC program before?
I loosely follow NeoStem. Today for the first time, I found they bought another company which has a 250-patient phase III DC trial for Stage 3 or Stage 4 melanoma with a SPA from FDA.
So I developed some interest at once and started to dig up a bit. Their method is basically the same as DCvax-L with only one small difference. They co-culture DCs with dead tumor cells instead of with tumor lysates.
The most important finding so far is that they have conducted a randomized controlled phase II study with striking positive results. The control group patients were injected with dead tumor cells.
NWBO currently has no facility in Germany to provide its cell product to HE patients. From 10Q, the company hasn't finished transaction of real estate. And it may probably take several more months to establish such a manufacturing base, hire employees, test run, reaffirm its products and cut a lot of red taps. Never expect this kind of thing happen overnight.
Believe me, there's capacity issue with hospital exemption program. The enrollment would not be disrupted much, if any. For this year, they probably would not enroll more than 20 patients in that program. And the patients enrolled probably won't qualify for the clinical trial inclusion standards, e.g. recurrent GBM or AA patients or children with brain cancer.
I have to restate my point:
Regulators can access the unblinded data if they want. They are called regulators for a reason. However, if any outsider bases his/her investment thesis on that, good luck!
And there is no reason to believe regulators can NOT access the blinded aggregate phase III data to date. If DC-L is anything close to our expectation, the blinded data, which won't hurt any aspect of the integrity and credibility of this trial, would be enough convincing to make a wise decision. The KM plot of the aggregate blinded data would look more like phase I than the ordinary one labeled “patients with GBM dying so F**king quickly”, given 2 thirds of the patients are in the treatment group.
Of course we can't prove anything so my investment theses are based solely on public information to date. And I am more than happy I invested in NWBO in the middle of last year. And I am more than happy that NWBO does have a solid business plan than being yet another science project company.
Authorities could access the data via DSMB as they see fit.
In FDA's guidance,
Almost no chance to hold the trail for futility at this very early stage.
I have to remind you that the phase II trial of IMUC did not meet its primary endpoint in the final analysis by a large margin but it wasn't killed in the interim analysis.
Unless dcvax-L facilitates tumor, it won't be stopped at 66 events not to mention that are many endpoints built in the trail. It is hard to imagine dcavx-L missed all of them.
fenix,
you can found every patient information of one of nwbio's phase I trials at
http://www.ncbi.nlm.nih.gov/pubmed/21135147
The author robert prins is also phase I PI.
It is a peer-reviewed publication and this paper along with an earlier one (http://www.ncbi.nlm.nih.gov/pubmed/18940004) explains, contrary to common belief, why young age is NOT associated with better outcome for the majority of patients.
Both papers are free to download.
Glioblastoma is the grade IV brain cancer. There is no higher grade brain cancer by WHO definition.
Alhough I have great confidence in NWBIO's story, IMUC's recent failure taught everyone "Do not put all your eggs in one basket" again. Therefore keeping a balanced portfolio may be a good idea.
Hope that helps.
Short interest as of oct 31 is only 784,282. So squeeze alone can not explain today's action.
I hope something really interesting around the corner.