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Yeah,
--
I think on many boards, one expects to be insulted or slimed…and some of us (like me) can get defensive before stopping to think the statement might instead be a turn of phrase meant to ingratiate or laugh with (not at) someone.
Price runs:
I think price escalation, assuming the trial halts, is dependent on the PFS, OS, ORR and extrapolations drawn therefrom. If the PFS is 24 months or more, OS is 3 years or more and the response rate is 80% or more, the price could (immediately) well run much higher than 100 if a halt of the phase 3 trial for success was announced before Direct results. It will take some time (days to weeks), after potentially great results for GBM patients, for the entire world to realize (internalize) DCVAX applies to all solid tumor cancers. So look for a longer price-run-time before any slowing or pullback.
On any pullback: (I'll timely use ICPT for comparison).
*ICPT had a 'relatively small' but significant pullback based upon cholesterol concerns in a fatty liver treatment. DCVAX is not likely to have a pullback of that significance, because Cancer is extremely fatal, and while DCVAX really has no side effects, any DCVAX minor side-effects (beyond the chemo/radiation/surgery side effects) will be of almost no concern at all.
*ICPT may use their drug for other things like alcohol related cirrhosis -- if its efficacy continues to be proven there as well. DCVAX on the other hand is already being used on multiple cancers in compassionate use programs internationally. Therefore, before any pullback, super strong DCVAX-L results will likely have far more than a 2 day -- AKA: ICPT -- gigantic run-up.
* There are always things detractors will come up with to knock a company down a few notches -- like NWBO -- if NWBO comes back with spectacular results; but, waiting in the wings is DCVAX Direct, and if that starts to demonstrate tumor eradication on multiple cancers with strong indications of immunity, and that information is revealed to the public on the heels of the DCVAX-L results, then it will be very very difficult for detractors or anyone else to stop the price escalation. When it dawns on people that direct could be used on operable tumors as well…the run keeps going…finally, if it is intimated that DCVAX-Direct may potentially work on non-solid tumors as well (when administration is modified), than you get the highest price of all.
* If Powers splits the shares early and significantly, she could actually keep the stock affordable enough that even old shorts will buy it, and thus, the run keeps going. In conclusion, Price to earnings is not always an accurate way to evaluate a stock -- when the entire world takes interest….I'll just leave it at that.
Diamond,
It depends on your priorities. He is always subtle/cautious, but there are two little gems (pun intended) I got out of reading it…. Especially if you already read his earlier articles and comments regarding NWBO. The exchanges just brought up by Austinmedia on Seeking Alpha -- a few posts back -- also expound upon his thinking -- as well as the thinking of NWBO supporters and detractors.
Its a kind or happy colloquialism from my childhood (a popular commercial we watched back then). I meant nothing but good will.
"Its good stuff Maynard"
Wow…
---
That's good stuff (Starting January 21 2014) Maynard…I mean Austin. Nice find. I wouldn't have looked back there without the tip. I think we will see a couple more informative posts before that exchange subsides. Go Longs:)
Long and strong.
Ha. Tricky.
On that matter, I do not have enough information to be persuaded to change my view. I'll say that I am well aware of the prevailing DMC general history on these decisions, but I'm still hopeful based upon my own research on dendritic trial studies.
I do not want to give Smith's proprietary information out. While his view remains positive, his details could alter one's thinking on which near term milestone events may drive the company forward. This could be good for some folks, and cause a wee bit of anxiousness for others. I wish I could tell you more.
Austin,
These will help answer your questions: The first review is free, unfortunately the second is not -- you probably do not need the 2nd review, but it will provide more data. Good luck. The links apply to DCVAX-L and similar therapies.
1. In the first review, pay special attention to table #1.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2810429/#!po=18.9655
2. http://www.ncbi.nlm.nih.gov/pubmed/19335279
3. http://www.ncbi.nlm.nih.gov/pubmed/16061868
Thanks for clarifying that. I appreciate your posts.
True, but it does not explain the 19 million share volume yesterday for IMUC, nor the 60% increase in 2 days. It will be interesting to see the whole story when/if it unfolds.
Ou, Thanks for the disrespect, I'm not offended.
*I do not invest in IMUC. (I have not moved a penny of my money out of NWBO.)
*I think it would be a fools errand to invest in IMUC, because I believe NWBO is better and 4 years ahead of IMUC.
*I am simply trying to determine why IMUC went up 60% over the last 2 days.
*I am simply trying to explain why it had almost 19 million volume yesterday!?!
*You may not care what is happening in a related company, but I do. I am still allowed to speak Ou, even though my mention of IMUC (apparently "he who cannot be named") sends you into a tirade.
*Because ICT-107 has not conducted a pivotal trial (yet), tiny IMUC would not have a market reaction like this unless NWBO was about to have pivotal results -- in addition to Direct preliminary results.
*Perhaps I need to point out why this shines a silver lining on NWBO. See below.
----
So, to your question, what do I mean by "If NWBO has bad results, IMUC is the last man standing in its niche."
Only 2 companies make products that demonstrate GBM results which significantly change overall survival. IMUC with ICT-107 is in one (just one) of NWBO's Niches, however NWBO/DCVAX is in a hundred other Niches beyond IMUC. If you don't want to acknowledge there is some risk involved in all trials, and thereby consider the possible consequences, this might explain why you are berating me. NWBO can fail Ou, but I do not believe it will. However, other investors and potential suitors are trying to hedge their bets; because, even though ICT-107 is not anywhere close to DCVAX; all investors know trials can fail, be continued or succeed at an interim review for efficacy. If NWBO fails Ou (again, which it can…but I do not think it will), then investors will (at least temporarily) highly value ICT-107 because they value dendritic technology that has made the only significant improvement in overall survival for GBM. They would value it even though it is only in stage 2, because it would still provides a midterm chance. (This does not mean IMUC is not targeted by shorts.)
Here is the silver lining, and why you might care. Those same investors and potential suitors know that if NWBO succeeds, it is going to put a lot of companies out of business (or, in a world of hurt). Many companies will wonder how they will ever compete with NWBO. All of a sudden, companies will be trying to buy up every other dendritic technology company in sight (NWBO might even eye IMUC). So NWBO's upcoming results are demanding this level of awareness, consideration and respect from others regarding NWBO's impact on oncology medicine -- even if those other investors are too scared to invest in NWBO directly. I fought cancer, I am not afraid to invest in -- and thereby assist -- a strong company like NWBO to continue the fight and look a phase 3 trial straight in the eye.
Here is something akin to a conspiracy theory.
IMUC is on a tear. I've not invested in it, however, they have phase II stats that will achieve statistical significance for OS in dendritic treatment any month now. Its just a matter of time….no doubt.
So, the investment in IMUC is a cagey multiplier play.
Here is how it goes:
If NWBO has bad results, IMUC is the last man standing in its niche.
If NWBO succeeds, IMUC becomes a huge takeover target by big pharma (in order to compete with NWBO).
At one dollar a share, people realize how fast their cheap shares can exponentially grow.
So IMUC is going crazy in anticipation of NWBO news.
On the other hand, NWBO is temporarily in a more unknown state than IMUC…..just for a short window. Investors already see the potential in NWBO, but NWBO is closer to 2 binary events than IMUC right now. IMUC has midterm upsides no matter the upcoming results for NWBO.
Nonetheless, NWBO also moved today because:
1. Results are expected anytime between today and early February.
2. Another dendritic stock went crazy (IMUC).
3. People and institutions are waking up.
This is the next presentation. They will review latest clinical data.
Dr. Marnix Bosch, Chief Technical Officer at Northwest Biotherapeutics will be presenting January 27, 2014 at 2:40PM
There are a number of prior posts dissecting Linda Power's January presentation for new nuggets. They are probably worth reading; plus Ms. Power's webcast is still on NWBO's website.
Austin, This may be of assistance.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3071163/?report=reader#!po=32.6923
DJ,
It was helpful that Linda Powers gave the public some numbers on NWBO's compassionate use program a few weeks after that exchange between AF and me.
GPB
Based upon some research you found, I modified my position a bit.
1. I think you are correct that median PFS survival for the control group is not likely to increase very far beyond nine months - at best. The (at first) counterintuitive results from the pseudo-progression group were the primary reason for my change in position. In other words, even though selection of patients is done post chemo/radiation (instead of immediately after surgery), selecting out patients who demonstrate progression and/or pseudo progression at this time does not lengthen median progression free survival of the remaining patients by a great amount, because (as you already know) the pseudo progression group actually has better historical PFS (compared to the non-early progression population), thus washing out much of the potential benefit. So, I think you are correct in stating that even with delayed selection/filtering plus intent for complete resection, PFS in the control group is not likely to go very far beyond 9 months, and certainly 10.5 months would probably represent an outer median extreme result. So that makes the range somewhere between 6.9 -10.5 months -- (with 9 months being the best guess).
2. After reviewing many early interim success stories, I think you (or maybe it was somebody else) is correct that the DMC will not set as stringent a hurdle in the first interim analysis as I previously estimated. I now think their requirement will be somewhere between .0005 to .001. Hopefully the latter.
3. After "tediously" trying to experiment with different curves, I agree it is hard to get much better than .00001 results, but I still find that if the time to event is even longer than the phase 1 group, and we have enough data from the earlier trial patients; even if the control group has better results than before, the probability value can increase compared to phase 1 if the experimental curve flattens out more than the control curve -- (with an additional modification to my lame prior visualization) that being the control curve must drop off to near 0-5% around the same time as it did in phase 1, and the median PFS is closer to 9 months.
Interesting, by excluding pseudo progression patients, I suspect the tail may even be shorter for the control group in the phase 3 trial. I don't think NWBO knew this might happen when they started the phase (II)/III trial a long time ago. This could improve statistical significance by a small amount.
4. My optimism for successful first interim results is not diminished, and if instead the DMC simply continues the trial, I continue to believe (for reasons stated in prior posts) the 2nd interim results stand an even better chance of success. IMHO
GPB/Ou
Yes that's the brief version. I wrote a detailed response to Ou's question, but it was jettisoned during IHUB's maintenance window. Anyway, safe to say, we are both hopeful. I'm still fooling around with Excel….wait….that did not sound right.
Thanks for the knowledgeable insights -- and relevant research. This is an ongoing education for me, and this company's journey provides a great opportunity for exposure to many different disciplines.
(P.S. I was skiing yesterday. However, the other poster speculations were entertaining.)
GPB,
Nice review with many detailed resection studies. The difference between the DCVAX-L study and those studies is this:
1. DCVAX-L Study: "Patients must not have progressive disease at completion of radiation therapy. Patients with suspected pseudo-progression will be enrolled and analyzed separately." Clinical trials.gov.
In other words, while I believe your numbers regarding PFS for control groups are very reasonable if patients were filtered immediately after surgery, I contend that since the baseline selection occurs after chemo/radiation (Stupp's protocol), the PFS in the control group will be higher than one might otherwise expect. Likewise, because the selection is conducted post-chemo radiation, and due to the synergistic effect of DCVAX-L in such cases, the PFS in the experimental group will be much longer. Remember, this study originated in 2005. The reason it was paused -- in addition to economic circumstances -- was to develop an appropriate placebo (much more difficult than one would think). Prior to pausing the study, if not placed in the experimental arm, the non treatment group did not want to continue in the study. Consequently, I believe the 33 carryovers were very likely to be in the experimental arm. That said, their data points for this trial give us a time scale that is rarely achievable in such trials. I contend when the trial started up enrollment again, they had to catch-up the control group enrollment. I think you can take it from there what this implies regarding where the more recent events mostly materialized from.
2.As far as visualizations, I'll leave that homely analogy alone. I will run/play with your numbers, however, it will take me a bit more time than you. I think the key point in my visualization left wanting was the fact that the control group still will curve to a finite endpoint length of survival, where only 2-5% will extend survival beyond 5 years.
In the meantime, today I am obligated to challenge several different curves with crystallized H2O, so I may be a bit slow getting back to you.
Astavraka,
Graph cutting was a visualization. Despite the temptation to plug current numbers in to reach a statistical educated guess, the posters here admit there are not enough data points. That is where art, science, history and 'weather patterns' leave room for human intuition. 2 Days ago I relearned statistical analysis, and it is amazing when you have enough data. If you don't, you must use inductive and deductive reasoning from multiple disciplines -- including statistics. I do not claim to know what is going to happen, and neither do the other bright people here. However, we all agree, from different backgrounds, that the dream is still alive.
In the event of a successful DMC review, NWBO is supremely positioned for a lightning bolt FDA application and launch. Their price point and platform for all operable solid tumor cancers will change the world. Their manufacturing ramp will be disciplined and already possesses preplanned potential capacity.
Did you enter:
1. 33 trx. patients were carried over from the phase 2 trial conversion? These patients started treatment as early as 2007-2008.
2. The synergistic effect?
Perhaps a simpler way to look at things. Old and new insights.
I came back to post this. See you soon….have a nice weekend.
Linda Liau and other researchers determined, before they started the current phase [III] study on DCVAX-L, that complete resection without any trace of residual tumor recurrence after surgery/radiation and chemotherapy has a synergistic effect with dendritic cell therapy when DCVAX-L is given on the heels of the Stupp’s protocol.
The current phase III trial only accepts patients with no trace of tumor recurrence at the initiation of DCVAX-L therapy. (The patients who are not selected are placed in a separate study and/or compassionate use program) This means legitimate and ethical cherry picking happened in the phase III trial and not in the phase I trials.
All current DMC interim analysis in phase III trials that considers efficacy have a predetermined stopping rule/point. For some reason, many posters do not want to believe this can statistically occur with 66 events. Nor do many posters believe Phase 3 trials (as opposed to phase 2 trials) can be stopped early. I have one word for them – Idelalisib. While we can all debate what the stopping P Value, Confidence Index and the like might be for the first interim review, we cannot IMHO debate that one exists for the primary endpoint (PFS). (Note 66 events is 60% of a total possible 110 events in the DCVAX-L trial. Idelalisib was stopped for efficacy in stage 3 at approximately 50% events)
Linda Powers graciously shared with us that patients with various cancers in clinical trials and compassionate use, had a “consistent” 80% response rate to DCVAX-L treatment. Here is an insight not discussed since that information was released. The current phase III trial will almost certainly have a response rate above 90%. Why? Because the phase three trial excludes patients demonstrating any trace of residual/recurring tumor at the time DCVAX-L therapy is initiated. As stated by Linda Liau in previous scholarly articles, the response for DCVAX-L (and other dendritic therapy) is enhanced significantly when there is no bulk and or trace of tumor recurrence after the Stupp’s protocol when DCVAX-L treatment is initiated.
Linda Powers also graciously verified that GBM treatment with DCVAX-L in clinical and compassionate use settings consistently extended Overall Survival by one-and-a-half years compared to standard of care overall survival, and it extended Progression free survival by one-and-a-half years compared to standard of care progression free survival. Here is another insight not discussed since this information was shared. The current phase III trial is almost certain to extend PFS (as well as OS) by more than 2 years beyond current standard of care progression free survival. Why? Because the phase three trial excludes patients demonstrating any trace of residual/recurring tumor at the time DCVAX-L therapy is initiated. As found in Linda Liau’s prior research, DCVAX-L’s effect upon PFS and OS is synergistically enhanced significantly when there is no residual bulk and/or trace of tumor recurrence after the Stupp’s protocol when DCVAX-L treatment is initiated. In other words, while PFS for standard of care might be enhanced where no trace of tumor is found immediately following the Stupp’s protocol, this PFS enhancement does not compare to the synergistic impact on PFS extension when combined with DCVAX-L treatment.
Like most of you, I have taken some time to understand probability values and Kaplan-Meier’s curves. Please review the DCVAX-L Progression Free Survival curve for phase 1 DCVAX-L used in Linda Power’s December 2013 presentation.
Below is my hypothesis regarding how the PFS curves will change from phase 1 to phase 3.
Its easiest to visualize it like this:
Imagine you print off the curves on the PFS graph from phase 1. Next take a pair of scissors and cut the 75% horizontal line all the way across the page. Now Change the 70% line to 100%. Next, remark the percentages accordingly all the way down.
That is what the phase 3 curves will likely look like. Notice the standard of care curve will be somewhat enhanced, but it can only improve so much without synergy, whereas the treatment curve will become much 1. Flatter/extended in months and 2. higher in percentage.
The P Value is basically the overlap and/or distance between the 2 curves. What happens when you flatten the treatment curve more dramatically than the control curve is you significantly change the P Value. The P value for Phase 1 PFS was .00001. Or 1 chance in one-hundred thousand that the beneficial results from DCVAX-L treatment were a result of chance. I believe that the phase 3 curve will result in a P Value of .000001. In other words, I speculate it will show there is only a 1 in one-million chance the results from DCVAX-L treatment were the result of random chance.
(Note: These results with sufficient data points would not be possible so soon if it were not for the 33 patients carried over from when the trial began almost 7 years ago. The Kaplan Meier’s curve would otherwise have “censored” data points where the PFS data point is not yet known. In this case, we are very fortunate to have a great number of data points from the very old treatment group as well as new data points from the recent control group.)
2 quick links. See you in a couple days.
Sequential Analysis is one of the keys to understand how the DMC is likely to analyze this trial in each separate interim review. IMHO
http://www.ncbi.nlm.nih.gov/books/NBK13920/
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=2&ved=0CDgQFjAB&url=http%3A%2F%2Fpeople.musc.edu%2F~elg26%2Ftalks%2Finterimanalyses.ppt&ei=RKjXUraFL9bdoATirYDgDg&usg=AFQjCNEqt7MTIOp6hap81pOMEGiLjQT5Ig&sig2=DrAQ1t2FVvzcoXldpA7LXg&bvm=bv.59568121,d.cGU
Stopping Rules:
Since the DCVAX-L two arm expected P value for the final review is .02 (instead of .05), for various reasons (I won't go into here), I believe/speculate the 1st interim review of PFS will demand about a .0001 p value in order to unblind the trial. I am only starting to understand this science, so take my estimate with a grain of salt. I would gladly take correction/redirection from a statistician.
(Had there been three interim reviews (there are really only 2 in our case) prior to the final review, I believe the 1st interim p value would have demanded a .00001 p value to unblind the trial).
Sorry Ou, I had to run off before doing a final edit on that last post. There were a few typos.
I'll be here and there over the next few days, so I'll likely not post during that time.
I just wanted to add this last opinion before my brief hiatus.
That is, I think NWBO's prior timeline was messed up by the German approval process. It required far more man-hours than previously thought; moreover, I think it required an enrollment slowdown. (Its just my hunch, but I think the Germans might have some predetermined minimum amount of patients contributing to the 312 phase III trial.) I think the German delay made all the timing go off course. For instance, NWBO was ready to share enrollment status updates from March 2012 forward, but when the Germans made their enrollment start date impossible to establish, NWBO had to just grin and bare it. Likewise, the enrollment end date had to be pushed back. Likewise the Final results had to be pushed out to early 2015. Likewise, NWBO probably does not want to upset the apple-cart with Direct until those German clinics actually open. European involvement is quite critical to NWBO's 2 continent plan, and the German regulators have, in my opinion, not been moving fast enough. People are dying. I arrived at this overall opinion after reviewing all NWBIO material for the last 18 months, poster comments, outside analysis and my gut.
Spot on Ou….
While I think they can pull it off during the first interim review, the chances for success definitely increase at the second interim analysis.
I know you're reasoning is more sound and likely than mine.
The only things I would add are:
1. The 9 months PFS for the control group I used was a conservative high placeholder. Recently, Roche tested a drug and they still got 6.9 months in the control group using the latest/best surgery techniques along with the Stupps chemo/radiation protocol.
If the control group in the DCVAX-L trial is more like seven months, that means DCVAX-l only has to demonstrate 13 months pfs. That places the patients considered for this interim analysis out to November 2012.
2. Do not forget about the 33 treatment patients that were included in the trial from several years back.
312 - 33 = 279 patients. Only 279 patients to enroll as of Jan/Feb 2011.
Scientist don't think in quarters but NWBO does -- my low end was 15 per quarter. 7 quarters
x 15 = 105 + 33 = 138 by September 2012???
Would 138 (or less) be enough to power this trial? This is an orphan drug powering scenario. The 33 tail will ethically tilt PFS and OS in DCVAX-L's favor. NWBO previously received a P value of something like .0001 for PFS with a 20 person trial. The cross-over arm, as I explained in another post, will not harm the PFS. Finally, the 80% response rate may be the final push to get us over the hump.
The DMC has their work cut out for them, hopefully the stats will make it a no brainer for them, because their decision could mean lives or strengthening statistical relevance depending on their recommendation. That's a very tough job.
I Agree John. This treatment will see the light of day….hopefully sooner than later. The DMC are running the numbers as we speak.
I may be in the minority on this,
but I think the additional statistics laid out in last night's presentation bode well for the 1st interim results. I am not going to pretend that I am a statistician, but I look at it this way. The primary endpoint is, by definition, the metric that is used to end the trial (early or late). Interim analysis that includes an efficacy analysis allows a trial to be ended before the total number of agreed upon events. The primary endpoint hurdle is 6 month extension of progression free survival. Historically, the Stupps protocol has at best improved PFS to 9 months on average. This means that DCVAX-L must at least show 15 months survival. We have now been told that, for over the last 10 years, in over 200 patients, PFS is "consistently" extended by 18 months. 18 months + (the lowest pfs from the stupps protocol 6.9 months) = 24.9 months.
Again, I am no statistician, but if we are seeing the same results in the phase 3 trial as we have in the other 200 patients (albeit some are not GBM), I have to believe the trial will be unblinded on the 1st interim analysis.
I know their criteria, but the statistical algorithms make my head spin. I can only use other prior drugs that were unblinded early as my guide, and if DCVAX-L has the above results, it would blow the other drugs out of the water.
The bottom line is DCVAX-L has to show 15 months PFS, if it continues to perform the way it has over 10 years and 200 patients, it will instead show 24 months PFS. If that is a given, the only question remaining is whether statisticians can extrapolate enough data with these astounding results to demonstrate the 1st interim results are not the product of chance (beyond a certain probability).
Good Points Red,
At the risk of repeating myself, I want to reiterate what impressed me the most.
I've been waiting for someone to give me compassionate use statistics,
Last evening, we finally received them.
Not including the phase 3 trial on DCVAX-L, over 200 patients received over 1000 treatments with DCVAX-L over the past 10 years.
* The cancers included (but were not limited to) Brain, Esoghageal and Merkel cell carcinoma.
* More than 80% of those 200 patients responded to DCVAX-L.
* Progression Free Survival (PFS) was, on average, extended at least one-and-a-half years beyond standard of care.
* Overall Survival (OS) was, on average, extended at least one-and-a-half years beyond standard of care.
* Only one patient had a serious adverse event possibly related to DCVAX-L out of 200 very sick cancer patients over 10 years.
(Prior to last night, we received a much smaller sampling from approximately 37 total patients in 2-3 phase 1/2 trials. In other words, last night's presentation just added over 160 patients worth of information.)
It still blows me away.
-- -- --
I mean no disrespect to cancer patients. I was/am one. We still have to laugh, IMHO.
Just possibly one serious adverse event amongst 80% responses in 200 patients over 10 years.
-- DCVAX Statistic.
Whether or not Steve Martin made more than one attempt for publication in the New Yorker is yet to be remembered.
However, he finally made it with a clever essay on side effects for medications. It was droll, followed by funny and climaxed with laugh-my-ass-off hysterical.
You'll have to judge for yourself.
Still, the point is, there is a deathly one-in-a-kabillion chance you'll die from a hangnail medication.
On the other hand, cancer treatments are just as likely to eventually kill you rather than cure you.
All cancer treatments, that is -- IN ALL SERIOUSNESS -- except for DCVAX.
Amazing.
I think your wager will result in a draw. Without looking it up myself at this moment, you sound certain on the 30% (so she probably misspoke when she said 25%), but I think any dilution would be long after the preliminary (first) patient "glimpses".
I'll take the wager in the spirit of camaraderie. I think we received more information on the overall DCVAX-L stats today. She wanted us to know they have 10 years and 200 patients (with 1000 treatments) with an 80% response rate. That is very high, and it is very helpful. (With only one….just one…possible serious adverse event -- amazing)!
Also with the above 200 patients -- including compassionate use, she stated extension of PFS and OS beyond standard of care was at least 16 months for each….which places PFS at least at 23-24 months and OS at least at 31-32 months.
This is also amazing new news because it includes compassionate use patients as well.
Have a great evening. I enjoy your posts.
P.S. I think her wording left room for her to have already actually seen glimpses of Direct results….I find this to be the case, because the wording sounds spontaneous and vague, but it is actually well thought out when closely examined. Example, 'we expect to be seeing glimpses early this year….and by golly, we are seeing them'
It makes sense to me that, at the very least, the German enrollment will start on DCVAX-L before they tell us anything about Direct patient results. I also think it is likely that they want to announce the opening of clinics for Direct in Europe prior to initial patient results here in the U.S..
Long,
The 80% response rate includes all "200" treated thus far (not including the phase 3 trial) -- this includes their compassionate use program for such cancers as esophageal cancer and Merkel cell carcinoma)!!!
This is new news.
Since NWBO will start to draw upon the German grant this week, I think we will see a PR (in the next 2-3 days) about the German clinic(s) opening and recruiting. Maybe the Germans will not wait for the first interim analysis to open their doors.
In today's speech, Linda stated the RECIST criteria was 25% shrinkage (not 30%). This is also good news.
"We expect to be seeing glimpses, and potentially reporting glimpses, early this year, and during the spring, and the summer and the fall."
--Linda Powers, 26 Minutes and 6 second mark. (Regarding Preliminary DCVAX Direct results)
So, reading into this (from putting the whole presentation into perspective), it sounds like they want to hear from the interim review on DCVAX-L, before NWBO starts giving us DCVAX Direct Glimpses.
I do not blame them.
She is clearly tired and very excited/restrained.
She just clarified that. We will hear Direct preliminary results early this year, and then the spring, summer and fall.
Over 1000 treated in the last 10 years.
Did I hear this right?
Only 1 possible safety issue over 10 years.
Welcome Hodge,
I'm keeping your wife and you in my thoughts and prayers. Be well.
3 NWBO presentations within the next 30 days.
Something is afoot.
Thanks again John.
GPB/John.
Interesting study John. I agree with GPB's analysis. It saved me a great deal of time.