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AK, I have been in and out of MBIO a couple times now, but missed this last bottom. Their genes for lysosomal storage diseases are also interesting. My concern is they have no cash and I am not ready for that trip again.
Karl, thank you for always staying positive and lifting us all up! If you saw Mt. Sinai (how Ironic is that? The eleventh commandmen - Know thyself), then you know that LL is pure of heart and that the kingdom is within you. Nothing is going to stop us now.
The data to build this model was provided by a regulator, likely FDA...trust me.
I have a new start your day pump song, provided to me by PGSD and to him by johnny. I still will follow it with Magnificent.
I believe LP was born like me. Her magic powers are that she can build things. CUT HER SOME SLACK.
If I am right, then it can all be explained...
“Waiting on Godot” by MI Dendream...F it now I can’t sleep.
First, Samuel Beckett was a member of a troop called the Theater of the Absurd with Albert Camus and Eugene Ionescu. I am a member of IHUB. I was born differently from others. My magic power is that I see patterns before most nuerotypicals do. This is how one who could not talk before age 2, is thought to be slow in 4th grade, scores a nearly perfect SAT in 6th grade. I did not have the vocabulary to do that then. People like me all have a special power. We also have a glass ceiling in corporate America. I saw this in August 2015. Linda is my rocket ship blasting me through this glass ceiling.
This will be the cliff notes version
Character 1: Linda Powers
Character 2: Linda Liau and Keymours Ashkan
Character 3: my ex-friend
Scene: Somewhere near Bethesda, Maryland
C2: It is August of the year 2015, it looks like we have arrived, are we there yet?
C1: No, IM UC waiting on Godot
C3: Look out for the potted plants
C2: It is now February of 2017, and we are hungry. Isn’t 248 enough for you?
C1: No, you see we are waiting for Godot
C3: Look out for the potted plants
C2: It is now November of 2018, our loved ones are dying, how can 233 not be enough?
C1: Because, our work here is not done, we have a future to plan for, we must prepare the Sampling of All Plan, you must look for mutations, I must build so that we can create, and besides there are advantages that go beyond 233. We are waiting for Godot.
C3: Look out for the potted plants
C2: The show is prepared, it is October 2020, the best theater is right around the corner. Surely, we are there now?
C1: It is important that we teach lessons for we have prepared, but they have not. Sometimes people need a slap in the face before they can realize that they need to prepare for Godot. We are waiting for Godot.
C3: Look out for the potted plants
C1: You ask, where is Godot? He/she has been here the whole time.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=163967195
If a patient lives to 30 months (~KM36%) then the median survival (~KM18%) is 56.4 mo (~5years)
If a patient lives to 36 months (~KM28%) the the median survival is 88.2 months (~7years)
What was the average age at entry?
Ex do you remember this argument(s - there were 2)? About KM predictability I mean
Now, remember the OS 233 argument?
How about my first equation? I was full TBI at that time. Edwin Moses! I too could not walk one week later.
If a patient made it to 3 years in 2017 (24%),
If a patient made it to 3 years in 2018 (28%),
If a patient made it to 5 years in 2020 (21%),
If you assume that the last 100 are DCVAX instead of 77, 3 years = 38.7%
Sounds to me like the Nordics will come on board fast
After US, Switzerland and Germany, these are your most profitable countries.
BOOM goes the dynamite.
Johnni, this data from the Norwegian database analysis should give comfort to longs not concern.
Survival Characteristics of the Potential Study Groups
We next compared the survival characteristics for eligible versus ineligible patients at different time points. Patients who potentially could have been included in a trial before the start of concurrent RT/TMZ had a median survival of 16.4 months, and the 2- and 5-year survival rates were 33.3% and 8.6%, respectively. Comparable data for the ineligible patients were 7.7 months, 14.0% and 3.0% (Figure 3D). Similar differences in survival were found at the two other time points for study inclusion (Figure 3E, F). The survival advantage for patients who fulfilled the eligibility criteria for trials at each time point was statistically significant (P < .0001, log-rank test). Compared to the group of patients who were considered ineligible for trials, the median, 2-year and 5-year survival rates were increased >2 times in the group of patients considered trial candidates
I am curious if the patient consent allows for their tissue to be used outside vaccine production. They may need to get additional consent.
So what you are suggesting is that with CRLs expertise and NWBOs tissue bank, we could grow enough and wide variety antigen to just use the patients own dendritic cells and incubate with the master tumor library? That is better than autologous tissue because it could anticipate adaptation of the tumor.
Very exciting ARCUS gene editing platform recently validated by Eli Lilly has reached first in non-human primates milestone and looks to be ready to take on muscular dystrophy.
Advance ARCUS-based in vivo gene correction programs into human clinical trials. In our preclinical studies, we observed the high-efficiency and tolerability of in vivo genome editing using ARCUS in a non-human primate model, as published in Nature Biotechnology in July 2018 and Molecular Therapy in February 2021. To our knowledge, we are the first company to complete this milestone, which we believe to be critical to successful in vivo genome editing therapeutic development. We have built on this early success by diligently advancing a diverse portfolio of preclinical in vivo gene correction programs through additional large animal studies, focusing initially on gene targets occurring in the liver and eye. As discussed above, in November 2020, we also announced a research collaboration and exclusive license agreement with Lilly to utilize ARCUS for the research and development of potential in vivo therapies for genetic disorders, with an initial focus on DMD and two other undisclosed gene targets.
The patents just keep piling up. Awesome guys! Thanks for sharing.
Sorry Ex, I know you would like to cast doubt here, but GESTALT has kicked in. The pattern is true even if a few details slip.
The apple never falls far from the tree. Congratulations Dr. Bala. You are building the future in all aspects of your life, and I and mankind should thank you.
Glad to have you on the team Horse. Let’s burn these mothers down!
If you communicate through music which I like to do, please listen to 28:44 through 35:35 closely all of the words matter. If you have already done so, sorry that I repeat myself
When FDA accepts a new endpoint, they require that you provide internal and external validation of that endpoint first
Datafer, I will repeat. FDA almost always requires a 5 year database to confirm safety, efficacy or both. If IDH mutation is applied to the phase III trial and then to the database, these data are caught up to current knowledge regarding risk factors. This would allow the current study to be used to validate this database, instead of the reverse, although it is an unending loop. IDH mutation is not required for the model built within the SAP. Those cannot be compared to the past as the IDH is not present in that random capture population.
Kind of like behind every strong woman is another strong woman.
This new database could then be used to build future random capture placebo arms, for future studies that build upon DCVAX-L as the SOC for all types of GBM...ndGBM, rGBM, and pseudoprogressed GBM. Everyone here should not forget that we have a separate trial in this last group and we will have data in this trial. These two can be used to validate each as well.
Thank you both Biosect and AEK for marking the truth to stand here forever in history!
If you choose to read this, you will learn one lesson that Jose Saramago taught in BLINDNESS, that is that you don’t need to spell, use punctuation, proper capitalization or paragraphs.
Another lesson he taught is that within mankind is an evil spirit that will come out of some people during times of chaos and nearly devour the good people of this world. But good people do exist, even during chaos. However, in the end, light will be restored and those people will have to answer for what they have done.
You take one day mostly off the board and you miss so much...I have much reading to do., but first I want to get back to this topic of TRUST that exwannabee continue to try to promote.please click back once to connect these thoughts.
Why does Ex want you to believe LP cannot be trusted? Well, one reason is to sow doubt that the study will ever end and results will ever be made public, I mean it is a 14 year trial, right?
This past month however all we see is PROGRESS!
In Utah and at CME LL showed progress on the SAP. She also discussed progress on the next steps after DCVAX-L is the SOC.
Through Swanton, LP showed progress on the regulatory filing and manufacturing
Through patent, LP showed progress on DCVAX-Direct
At the ASM, LP discussed further progress on Manufacturing capacity, confirmed plans with Direct, and CONFIRMED that she intends to PUBLISH DCVAX-L Phase III clinical results.
The GESTALT of all of this is that shorts are screwed and they know it!
I do believe that now they would like to get out. They will try to drive the stock lower in order to do so, but if we hold the line or actually buy into these attempts, they cannot.
One thing that I would like to do when things reach a crescendo is travel to the UK. I have always wanted to see those crumbling CASTLEs.
I in fact love history (Is this creepy LC?). My mother gave me this passion. I would like to stay in one of those restored castles because this helps to restore faith in humanity. As does LL and LP and history here helps me restore faith, not destroy it as Ex would like you to believe.
Biosect, I know that I have been hit or miss with predictions of news, but my guess is the next corporate piece of big news we get will be UK Regulatory package submission. Won’t that be a bombshell.
Also, LL will continue to add detail before TLD.
You know, FDA approved Spinraza in under three months. I am pretty sure they didn’t have any special kind of anything either. FDA can move quickly when the case is clear, manufacturing is set, and lives are at stake.
Some here have questioned my integrity of late. Not my friends, this statement is not for you. I guess you miss a prediction on timing and that opens a door.
So, if you question click back to the beginning of this stream and read through. I welcome debate. Or click back on the other stream I like to reactivate. But first learn my belief system. I will add to this over time, and some have already listened along.
Ripple - one must always start the day with this on the mind.
Thank you to the prestigious mega-minds that are the neurosurgery/neurooncology department at Mt. Sinai, one of my personal favorite institutions.
YOU DID NOT DISAPPOINT! And you share my love for Linda Liau. There are many kinds of LOVE LC2020. Few if any are creepy.
Ex my friend, I am glad you finally engaged with me again. Hello, friend. I have been calling for you. You have been staying away from many of the posts I have written but I do welcome your criticism. In fact, I enjoy it! Interesting that you choose the abstract TRUST rather than the concrete that I have been laying down this past month. Are you picking up what I am putting down? But to the reply...
We hope to present TLD results around the end of the moth(SEP).
We hope to present TLD around end of June or early July.
You can do the math and add the several multi month steps to Dec 2018
We will start start the process of several multi month steps when the event count is reached (Feb 2017, and the presumed count was reached that summer).
We expect to have results by early 2016.
We expect to have results by late 2013 or 2024.
By end of year (2007) patients from all over Europe will be flocking to Switzerland for treatment.
Flexroy, as I understand it, what she was telling them (see my first quotes posted earlier midday for ae kuster) was that they learned a lesson that sequencing PDL-1 and DCVAX is critical.
That by giving PDL-1 as a neo-adjuvant therapy it caused a massive invasion of macrophages at the wrong time. That this caused hyper-inflammation and may have limited T cell function. In general, macrophages clean up the mess. So she tried different things to control the inflammation. First they gave Toclizumab to try to slow it down, and she did surgery again (I think). Then they gave bevacizumab to try to alter blood flow before DCVAX. She referred to all of this as needing to use adaptive trial designs.
The hidden message - Linda Linda did everything in her power to try to save that man’s life including multiple surgeries and new ideas for experimental approach. She is unrelenting in trying to find a cure and believes that every single one of our lives has value and should be fought for. Everything she is doing involves DCVAX as the backbone. She is trying to make DCVAX better, And she is saying to Mt. Sinai, once you have DCVAX in your hands, try whatever you can think of if the patient doesn’t seem to be responding well. You may have all the tools that you need at your disposal already, but if not never fear because I am doing more gene sequencing and talking to other fields to try to learn how we can boost this powerful therapy.
You don’t because you don’t know me, but others here do. I may have told white lies, I may not have.
I have said that I share what I know in good faith. I have also caveated my postings, especially if those postings share key insights with statements that include the fact that I am hiding behind an alias...only one as I believe multiple alias is unethical. I have provided you with an old alias used on an old message board similar to this one, both board and alias. I have told you that you should not trust people hiding behind an alias. Trust your heart.
Gary has shared with you his name, I have shared with you my belief system among other details. Trust is up to you. It is always up to you.
I trust Linda Liau, Linda Powers, Marnix Bosch, Keymours Ashkan and Dr. Prins. This choice too is your.
Yes, Librarian but your interpretation of this history is WRONG.
I equate what she has said and what she was doing when she misled to the role of Investor Relations. IRs job is to keep investors happy and keep investors invested. She did tell us from the outset that she was taking us all the way to the end. She also told us that the screening halt was good news and not bad as the shorts were saying.
She said what she needed to say along the way to keep long term longs like me in the game. Her intention was to do what was in our best interests. I call these little white lies and I am ok when people tell them.
I can give you a few quotes that I wrote down...
Related to the PDL-1 combo study... one patient that they adapted treatment to in order to see what may work at boosting response.
“What we have found was not what we expected. CRP goes up very high after each time we give the vaccine”...we had to go in and surgically resect the tumor again and “pathologically it came back as inflammation, after we had to take him to surgery” alone these were TCells but with PDL-1 blockade macrophages flooded in. “So maybe it is not timing but sequence that matters.”
Regarding why other vaccines fail overall but may have helped a small subset...”you actually need the tumor there as the source of antigen” there is too much heterogeneity within the tumor itself.
“There is a huge battle going on in the brain...we are currently doing single cell sequencing to see where to go next”
Tony Rebus at UCLA has collaborated to discuss melanoma and any lessons there. Tcell exhaustion may not matter “what you need to do is drive new young Tcells into the tumor again and again”
Conclusion - I don’t give a damn about today’s price action or next weeks or the weeks after.
We have a winner and her colleagues agree, now on to the next challenge, how do we make DCVaX the new SOC better? Please tell us oh oracle of oracles.
You don’t need FDA approval to use drugs on the market for other indications. This field will evolve rapidly once they have DCVAX in their hands.
I am shaking with excitement!
OMG - here come the questions which will tell so much.
LC, I learned from the best. I would just go back to WI Dendream. My wife is okay with my stance on LL, so I don’t know why you care
Listen to the questions? Look at them take notes
BMS collaboration with CS1 inhibitor to augment macrophages?
Boy she knows her stuff - pediatric tumor genetics? K27 mutation that is also xx4 is quite different
All of these questions are based on the assumption that DCVAX works and how do we make it better!!
Can we distinguish pseudoprogression with MR Spec? No, bur a OET Scan with a good tracer, we are looking at...
SHE DID NOT DISAPPOINT, NOR DID MT. SINAI!!!!!
OMG - I am seeing Linda Liau live!!!!
I am a clinical science geek. You cannot understand how exciting this is for me. OMG - this is a great day regardless of what they do down the street from Mt.Sinai. She is on the mountaintop preaching.
OMG - I have goosebumps and heart palpitations .
Isn’t she Magnificent!!!
“Linda you are following in some very large footsteps”
Look at those brilliant smiling faces praise her. They are all mega-minds themselves and they praise!
Bright Boy, I am no expert on how to run a translation stage company but you are. Thank you for your analysis. It seems we both remain quite confident in LP. I remain in awe of her.
She is clearly on a mission and one of those is to strike back. This excites me. This motivates me. The fact that she is being very careful and thorough is consistent with her character which excites me more. The fact that she is employing a diverse group of scientific and clinical experts to help guide her should add confidence and gets those emotions stirring in me once again.
Oh ship, I feel the cheerleading coming back. I am not pumping, I am praising. Maybe I should shift my focus to LP. She is our captain, LL is our navigator and they are one hell of a powerful team!
BTW - we were all going to be disappointed about timing with or with my cheerleading. My cheerleading was much more thorough than ASCO for any paying attention. ASCO was actually a small piece of my enthusiasm. Oh boy, I am being stirred but I have a very very busy day and evening. Tomorrow I suit back up.
I am no TA expert, but it seems to me that we saw last week that it doesn’t take much volume to push us higher, and there seems to be strong support when we get pushed lower. Low volume days can fluctuate but they are low volume days which tells me longs are holding.
Chaos creates opportunity if one has the strength of conviction which hopefully the lead up to ASM gives us.
The more I think about yesterday, the more positive I become.
We learned some new things about our manufacturing registration in the UK - this is positive. Coming online for existing projects by end of Q3 - this is positive. We learned more about the Flashworks implementation - this is positive. We learned that they are still in a quiet period which means they are unblinded to the results - this is positive. We learned that they still plan to publish the data - this is VERY positive. Aside from the fact that publication bias assumes this will be positive, she sounded quite upbeat about this process. We learned that the regulatory process proceeds - positive.
“We serve you best by moving through all the stages that we outlined thoroughly”
She was also very affirmative about DCVAX-D will proceed once the get through the process with L - very positive.
From Dr. Liau, we got a nugget slide that connects the statistical model for the comparison group to the primary and first secondary endpoints. This is VERY positive. I can’t wait to hear her explain more this morning. The statistical comparison is the Cox proportional hazards which is positive, but also two other shots on goal which together will add confidence to the result. We also learned by these comparisons that this data will not easily fit into a TLD PR for the public to consume.
Add this all together and it was one heck of a positive day.
Sure, our timing is delayed from my anticipated timing, not theirs, and it remains unknown which may be a good thing. My guess is that the next big news we get is officially submitting a package to a regulator, then three more. This is the bigger fish and confirms positive results. For two regulators it means even more.
The publication path may come to fruition soon or it may take several more months. We have other congress to speculate about in the meantime.
Shorty has a lot to worry about. Me not so much. It was a GOOD DAY. Don’t be disappointed that it wasn’t a great day.
Biosect, I was definitely a factor in creating the noise around ASCO, and I was clearly wrong. I am wiping the egg of my face now. I appreciate that you and others put caution to this hypothesis. While I did not put all of my eggs in this basket, I did put many of them there and I apologize to those that believed in my ASCO prediction. This too is a pattern that I was unwilling to see. I don’t understand why we are spending money to sponsor there again since money is tight, but no big deal.
I also predicted that the ASM would not produce TLD and tonight’s CME will produce nothing new as it is CME. These were correct.
Slow down everyone, this is not a big deal. Does it add uncertainty? Maybe a little, but not much. If they are seeking publication this is a long process which is why I favored ASCO. Nothing she said discounts this approach, in fact it was indirectly reinforced.
So what changes? Well, this means that data wasn’t in place for ASCO submission. This shouldn’t be too big a surprise, we are in a pandemic and there are a lot of nuance to these data. Nothing she said today takes away plan B, publication. In fact she referred us back to the 10/5 PR where publication is clearly listed as the last of the six steps. There are other conferences with other deadlines, so scientific presentation is still on the table.
Manufacturing certification in UK is proceeding.
Flashworks is being implemented
EMEA and UK approved the new endpoints
Linda Liau presented a very impressive statistical model in Utah.
Linda Liau still has NYC and UCSF - at the least she will cover the model again, but could provide new insights
The KM curves presented in 2017 & 2018 still provide clues to how the populations are acting
The KM curves still look very favorable compared to the statistical model
New patents are still being sought and accepted.
Warrants and options are still handcuffed
No new stock shelf has been requested
Consultants for uplisting were still hired
Regulators still agreed to halt new screening without stopping treatment and in fact forcing removal of placebo
DCVAX still has the potential to earn billions
Regulatory submission preparations have not changed at all
My timing may have been extended, especially if NEJM was pursued, but so what. Would I have liked a projection for TLD? Absolutely and this remains frustrating, but if publication is the hold up then they can’t provide much more than the coming months which is the last projection we got.
I thought what we are all about here is sharing the love, our experience, and fighting back.
Well the fight has begun and in my mind Linda Liau threw the first punch in Salt Lake City.
My experience is this... I started in pharmacoeconomic research, moved to medical communications, took a brief stint in R&D where I also worked with the head of PR on communication, then I moved back before switching to marketing which is where my talents best serve. What have they served? 8 launches, all successful, 5 of them Blockbusters and now this will soon become 6. My specialty is KOL management. I know these people very well, like thousands of them.
DCVAX does not count, I don’t work for Linda. I will if they need me, but it would have to be part time because there are more important things than launching a drug. Although this drug is different.
So what? Investors stay invested, traders run for the hills. If 15k becomes 14k, why should I care? I would like all 15k to stay and even grow, but if it shrinks, then my piece gets bigger.
I will keep cheerleading and you run your business as you see best. I am someone who likes to share my light with others and hope that they find the light within them. If you don’t like my light, then look at the Lindas, their lights are brighter anyway.
Time keeps on slipping into the future and I want to fly like an eagle. Come join me please...
774M divided by 15K = 50k. You don’t believe that retailers own 50k shares each on average? I can count dozens with more than that.
Who is to say what is impossible? I can feel the change in everything. I don’t want this feeling to go away!
Only 15,000 beneficial shareholders. I love this number! Viking, this is why I cheerlead. When you add us up along with our minions and those holding friendly warrants and options, we have enormous power if we hold the line. If we get excited about what we own, we do not need to react to time. Slow down everyone, you are moving too fast. The goal is well beyond approval. We have something more special than $10.
5 of those beneficial shareholders are in my household so this number may be inflated.
If the LC comment that retailers only own 70M shares is true then my people make up a big share, which I doubt. I think he is off by a factor of ten
Do I know you KK? Did you get me into NWBO? If so it has been way too long since we connected. I will figure out How (or Hao) to reach you.
I owe you the biggest thank you of my investing life.
If not, just ignore and I will find KK anyway.
The frenzy is to help everyone see what we have and stay the course regardless of what happens over the next few months. When the next attack comes, I hope everyone sees this as opportunity not panic time.
It is already in the minds of both Lindas. Have faith my friend. The train has already pulled into the station, we just have not yet been asked whether we want to disembark or continue on. The right answer IMHO is to stay on this train for as long as you can.