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I am saying those that try to sow doubt by pointing at a self-imposed quiet period and questioning, whether real or not, is a red-herring.
I believe on Aug 2015, FDA agreed to put all patients who would have gone on placebo (and those still on placebo) on to DCVAX instead. This changes everything present and future and future once again. There is a way to know outcome without unblinding anyone who should not be unblinded. The answer has always been there bc Geneva Conversation requires it to be there. Death is a safety outcome even in oncology and all are investigated in an unblind fashion by a select few. This trial is randomized 2:1 which adds power to this observation, figuratively and literally.
This agreement to move forward comes with certain responsibilities. On both sides...Those responsibilities carry forward as one negotiates...as one decides how to address the beyond...plans must be laid before unblinding. This likely includes a plan for the future, you know after SOC is established.
All of these things must be silent until that regulator allows publication of a data set. Similar to how ASCO requires that they come first and severely penalize those that break their rules without permission.
Spartex...that is my point
I am not an investment advisor, I am not your doctor, you must not trust my opinions. You must make decisions on your own and this includes investment decisions, medical decisions and any other decision including whether or not to follow the sun. You walk alone in this life despite having a village around you. I am not giving anyone here any advice to do anything you have to make your own decisons based on your own opinions. Period.
That is a logarithmic scale isn’t it?
Sojo thanks for all that you do for us, you too Kk
There is one more to listen to and you can find them all for free on youtube. I can recommend version for example, Sting live in Chile is the best, trust me.
Sacrificial Bonfire on Skylarking by XTC
Burn up the old, ring in the new. Change must be earned. Sacrificial Bonfire must burn!
To all of my friends on this board, the answers have been starring us all in the face....they go like this for everyone who reads
There is a road, no simple highway
Between the dawn and the dark of night
You walk alone
If you should stand, no one may follow, no one may guide you
Follow the SUN
Be yourself no matter what they say
I don’t know whose back’s that strong, maybe find out before too long
Let it be known, there is a fountain that was not made by the hands of man
If I knew the way, I would take you home
YOU and I will MAGNIFY MAGNIFICENT
Ripple
Follow the sun
Englishman in NY
New speedway boogey
Ripple
Magnicent
Those are the answers as well as all of the other words to those songs. Thank you, Jerry/Robert, Xavier both of you, Sting, Bono/U2, Linda/Linda/Robert?/Marnix
We are all so close to finding out whose(plural) backs are that strong and whose are thin air
I have to add one more name Somewhere between Sting and Bono....Edwin MFing Moses!!! That one is for you Dr. Shoreland
What a great way to start a morning! Thank you mue and survivor, Unfortunately you said U2 which makes me think that
Behind every great woman, is another great woman....
Every day, even when I get no sleep...they are magnificent aren’t they? I assume Lindas’ names are on there
Holy ship! That is amazeballs. Thank you for sharing!
I don’t give a damn about Woodford... I am talking about Linda’s
I want to take this moment to thank the one person or persons who have always been my source of strength, who have always believed in me and did not care that I am different, that advocated for me in 4th grade when ignorance thought they saw the opposite, that did not understand what it means when their child does not speak until they are almost two, that do not realize this is passed on down the line, that does not realize one can learn to adapt to what is expected, that know that that same person is about 30 for 31, that served as a source of strength during the darkest times here which happened to coincide with the darkest times HERE, that deserve what is coming to them and should live in two places one during winter months and one during summer. Thank you for believing in me.
Biosect, I have not read beyond the first s three sentences. There is another path that does not involve unblinding by anyone except those that are always unblind.
Count me and my minions in Dude!
Yep, and all of those genetically engineered and adoptive transfer mice and in vitro platforms will accelerate phase 3, 4, 5 and beyond so in the end it may be the faster path to true success.
Some people start fast out of the gate, some people pick up steam along the way, and some people build a plan, think through all of the potentialities, determine how their enemies may act, destroy the reputation of one powerful enemy, then begin to execute their plan. Some would call that 3D chess.
Others may realize that that Enron experience that some like to provide as doubt, may have actually have provided quite valuable experience.
Logic usually wins in the end as was evidenced in January of this year. Yep all that chaos was only 4 months ago. It seems like forever but only 4 months. This great experiment was almost destroyed. Some forces will do just about anything for themselves, but others think about mankind.
I choose to Follow the Sun which is not an individual and does exist in everyone of us if you choose to look for it. Some shine so bright though that they help others to find the sun. Some shine so bright that they help mankind to find the sun which will lead to others building on this knowledge.
Which according to my best friend who disagrees with me on the first statement, will lead to mankind finding a new sun which we can explore and colonize. Maybe Elon Musk and Linda Liau are actually on the same mission despite working different paths. Maybe not, but I do think many years of life expectancy gain is worth more than rockets ever will be worth.
I sure as heck hope she does not give this baby away for a song, which IMO $14 would constitute. I am not sure if any BP is willing to pay three or five times that, but that is really a bargain too.
LP knows these things, she also knows the current state of affairs with FDA which shorts continue to want to deny. So IMO, any offer to acquire must include enough stock to keep LP directly involved in the follow through and by directly I mean at least two seats on the board, maybe three or four. A merger with the other path is far more appealing because it will have an immediate pay off that would satiate all of my needs while leaving the potential for me to not only provide multi-generational wealth, but also endow a very meaningful philanthropy.
Back to my other point, while I do understand that all the factors in play may prohibit ASCO release, if they do not...why would anyone miss the opportunity to do both? Don’t both Linda’s want to sing from every Mountain Top?
OMG I am so excited that I can’t sleep. It is taking horse tranquilizers and a cocktail of sleep aides for me to get any respite. I can’t stop Dendreaming about all of the possibilities and how bright the future is thanks to Linda, and again I am talking about both.
I also can’t help myself, but will stop for now in case I am wrong about ASCO and the once in a life time opportunity presents itself one more time.
Here ye, Here ye! Come one, come all!
A soothsayer has shared knowledge for all to read. Ignore this soothsayer at your own peril. Join this soothsayer if you dare.
Self imposed quiet period. What a joke this attempt to sow doubt is? You agree Porter Laker.
Is that near Kalamazoo or some other lake somewhere else? If so, are you connected to me or my new friend PQR in any way?
Flip, I assumed that you were. The comment was meant to add, not inform in your case, but I do apologize if I have offended thee. Perhaps, a few questions may alter the energy.
How is the modeling performed and where did the raw data come from? The answer could be authorship teams, but I highly, highly doubt a competing company would cooperate in any way, no matter their state of affairs. The raw data is required to perform the model, it cannot be interpolated from graphs.
Which one of the four is most likely? They seem to be dealing directly with Germany, not EMEA, despite the fact that there is little difference.
When a regulator requires that you put all screening patients on treatment and forego placebo, would not that apply to all patients remaining in trial and not just new patients? I figure you got this too and the implications when comparing 2017 to 2018.
Does not this requirement come with certain other responsibilities, even if no promises are made?
What data would they need in order to make this decision, to change everything I mean? They did make this decision to allow one to move forward and thus change everything didn’t they?
If no interim efficacy analysis had been performed, then where would this data come from?
Was there not a back and forth at that time?
Don’t these questions already tell you their state of mind, even if a company wants no future doubt and has their eyes set on the long term in both GBM and beyond?
Did not LP tell us she was going all the way, which I did assume was 233 but then came around to what was truly meant? Did she not also tell us these were good things as if she could not understand how anyone would interpret it any other way?
When did the US process begin, was it November 2018, October 2020, or was it August 2015? Something I have known for many years now.
Does this process not REQUIRE silence? Does this explain most everything? Including our current state of affairs?
Does this poster know about that which he speaks or is he just full of ship? Do the answers to these questions give others more confidence and strength?
Should we not Follow the Sun and isn’t she Magnificent? I am talking about both Linda’s here
Aren’t the shorts absolutely screwed even if they still hold on to misconception? What is the risk-reward relationship for both sides at this time?
Are all of these questions MOhh diarrhea of the mouth? Did you stay up on this readers posts, did you just arrive, or did you assume I would let your comments fly and not continue to stomp and stomp and stomp?
Do you know who broke the news of 32 immediately after publication?
I truly am a gentle soul but I do not like people who insult me or those with disabilities, and others on the board using terminology that is absolutely offensive to others with other disabilities and more importantly actually, their loved ones. MOhh.
I will not relent MOhh. You have made an enemy.
I think what he is saying is that sophisticated attacks require a more sophisticated defense, or even one that becomes a trap. My words not his...actually it is borrowed from others here but I don’t know who to credit
Some warrant holders are, some are not, but thank you for the warning LC. You have my best interests at heart, don’t you? What is important to me is that the 30M shares have not impacted the price. I think those may not be friendly warrant holders, but if they are....
Short squeezes create very short term opportunity but one must be liquid to take advantage
If I could hug you Lykiri, I would. You in particular gave me much strength throughout this all. I in turn passed it on to many
Flip, if someone else thinks they should be SOC, they will have to run a 5-8 year long trial to prove it.
Even the gene edited off the shelf dendritic cells because they must prove they are better.
Some people go to the driving range, some people play 18 holes, and some people win, I don’t know not my game because it is too long, but some people win like 4 Masters.
When the mergers occur because the trap has been set LC, your bosses will regret it all. Even the phase 5 article.
Hoosier, Agree completely, sorry about the comment about your state. I am a FIP. We both have opinions of each other, neither of which are true but tribalism is something real which we should guard against.
In the end, does it really matter if you spend a few more pennies or even a dollar more than you should have?
Does it really?
Although it seems that they won’t accept reasonably sized blocks.
I know I repeat my self...i usually add detail though.
To be clear, I am absolutely in love with LL. Not in a creepy way, my wife has 150% of that part of my heart, and my kids have 300% of the other. In the way I also love the light within me.
If Lebron James is worth what he is worth and no one seems to care, then she is worth trillions and BTW, I expect she will give most all away in the end. But you see...this too is an entanglement and one you should not take lightly. She and UCLA have put everything on the line.
This morning, please click back and please listen to the link provided...there are only 5 days left.
The morphine comment is a low blow. You realize that people are going to jail and the industry is applauding. Some people get what they deserve and make everyone else look bad. That does not mean you throw out the baby, with the bath water...or if they have a condition that will not allow them to lift their heads and will in short order kill them.
Unless that salesperson helps you get the first dose free so as not to delay anything because time is muscle. We can fight the evil empire together later, but this baby needs this drug and they needed it in utero, but those tests are not done so immediately after birth will have to suffice...for now. I am not sure where the new oral will play into that equation as it really mucks everything up for one company who was criticized for charging so much, but in the end may never recover their investment.
BTW that paper came out in NEJM years afterwards, after presentation, after approval, after launch, and was accompanied by an editorial in a competitive journal that called it the greatest medical breakthrough in the history of medicine...and it required one hell of a commercial lift (from what I can tell), also possibly the greatest in history. All of this will be easily transplanted by DCVAX. That drug will be an afterthought soon enough....
Ike, I don’t pay attention to those guys. Were the rat studies in question rats or mice engineered by Charles Rivers Labs?
There are a few that make their own animal models, so not necessarily, but highly likely. Rats don’t always translate into humans, they aren’t nearly as complex, especially their immune systems. But they are a good first step which may be useful if you want to screen many disease models quickly in order to prioritize your trials.
Boom Muee! Nice one
Rewind the clock and ask yourself the same question about SMA? First, go look it up. Then go ask a neuromuscular specialist, pediatric preferred, but you have to leave your state because that half-backwards location can’t properly take care of those kids. They must go to Chicago, Cleveland, Columbus, Grand Rapids, Detroit or Ann Arbor... Louisville if the live further south. If you want some names to call, perhaps I can give them to you. Perhaps not
How about spinal muscular atrophy? Do you even know what that is? Well, believe me or ask a neuromuscular specialist...you need a village.
Darn it, MOhh! I can’t sleep until I get this off my chest. That is the old ego bringing me down.
You know, by referencing (inaccurately I might add) what you referenced, you actually prove rather than disprove my point. Since I and my other friend are not the “embiciles” here I will spell it out.
LP stated she would not move forward before all 4 agencies have agreed- if you believe her which I do. Everything almost, except September 12 because that was to prove a point which I completely understand.
She moved forward on October 5 2020...get it?
It does not take seven months to do what has been outlined, believe me I do know this...Or don’t... I am hiding behind an alias?
So why are we still waiting? One answer is publication, the other is ASCO. You can have both but one which invites wallstreet to their soothsayer congress requires that they come first.
I actually do have to get some diarrhea out of me now and then I will go to sleep.
Half the .... to you bro...actually full peace sign. I am just playing around.
You know, one disadvantage to being so narrowly held a stock on OTC is that we don’t have enough fire power to get the price up, at least not us retailers. The advantage, however, is that you cannot do a hostile take-over. We have to agree with the price. Not us retailers, but you get the point. Do you ex-friend?
Sales people in today’s specialized industry do much more than wear lipstick. This is insulting to many hard working professionals that pull patients through complex systems in support of the providers that they serve. Most specialized physicians actually do welcome this industry support and I am quite proud to know many, many good people who span the range of attractiveness and sell drugs.
But I do get your point and respectfully disagree. You absolutely need commercial enterprise to get this drug to as many people as fast as you can, especially in spite of the evil empire. Please direct your animosity at the right place in medicine. Middle men take 50% from both of us, provider and innovator alike, and you pay the bill, one way or another. In our case, that salesperson will help that indigent patient get access to our free drug programs which if you think about it is clearly a loss even after deductions.
I was really busy typing...I don’t type. I was typing while you were but we are in the same place I believe.
Alright biosect, I am glad we are in a very, very good place together.
My besty asked me to slow my roll, not for the reasons MiOhh suggested, but I responded, why should I care about that? We are satisfied aren’t we? Maybe not, but I will take the action as a sign.
Remember, LP once told us long before MiOhh was paying attention that all BP comes to the table with is money. Now, I did state the case for Merck and everything they can bring to the table, everything that it will take to really get this job done and time is money so do not fear. Time is money, BP knows this very, very well. That’s why FDA made Accelerated review certificates a marketable security for orphan drug developers.
There is always another way and the track may have been laid from the beginning. What industry company is not pharmaceutical? Why would you need to hire consultants if you are not doing an R/S? I really don’t know this one, but I doubt that we will ever see a R/S, split maybe.
I can give them names of two or three good staffing companies that can transfer or rent their patient services, medical affairs and/or sales force. But you do need to make sure that you have enough capital, worldwide manufacturing needs to be able to meet logarithmic demand, a basic research division would be really nice as well. I am sure that you may need to spin things off because it seems one step too integrated since it is already practically a monopoly. Two monopolies may not fly so well. The revenue though is part of the deal, but I guess a spin off may raise even more capital.
Now if anyone is still bothering to listen to me after my friend MiOhh tried to discourage me away. People who are reading know better Mike, I do have flaws and one of them is ego. I try hard, I really do so please forgive me. When a plan laid like 7 or 8 years ago comes to fruition and you spread the love far and wide it is hard not to be excited.
So I go back to that statement, what if in the end all BP really brings to the table is money? I like to ask questions Ohh, that is what I do. Now sir please stick this in your ear, then do not worry about diarrhea it is usually just something you ate but get it checked out if it persists by your own physician, then stick it in your brain...then ask yourself....
What will LP accept? Really, what is it worth to accelerate things a little bit? How many bidders are there? Is there a number that must be stated before she will even listen because while the deal is not done a plan is already laid? And don’t you think that number comes with both cash and stock and at least two board seats?
MOhh, I frequently make spelling errors and have dyslexia but i am no embicile and neither is that person you insulted. Actually, if you had a deeper understanding you would know thst those two traits correlate strongly with another and it is not what you spew. One of my favorite authors Mohh is Jose Saramago, you should read him, he won the nobel prize for proving a point. Start with Blindness, but they are all good.
I am not your advisor of anything. I do not have the authority to provide financial, medical or any other professional advice to you. I am hiding behind an alias. According to MikeOhh, hi Mike, I have a new medical condition which adding to my current condition is quite scary to imagine. You should not trust anyone hiding behind an alias. I believe that you have a light inside you. I believe that Dr. Liau has a light that shines so bright she single-handedly, well that is not true Dr. Prins, Dr. Askan and many others also had a hand but you get the point, she added numerous years to the life expectancy of mankind. When the lesson that the kingdom is within you grows to add other cells with other programs, my best friend thinks we will finally be able to colonize the galaxy because we may live 50-75% longer. I hope that blows your mind.
Peace, love and understanding to you all! Good luck only to longs, though.
Now we are talking, Gilead...are you interested? Eli Lilly, you have shown interest in this space, would you like a numbered placard too? Nothing is final until it is final.
Ok thank you. I appreciate your input and respect your opinion. No hard feelings on my end.
Thanks for sharing
Your assertion is not backed by your referenced material. You are welcome to be ‘out’ and to stand by your opinion, but others should recognize that is what it is your opinion and not backed by your references. Hopefully, people are able to tell when I am serious and when I am just playing around. You can ignore me if you wish,
Question 10 is specific to SAP, not approval. Perhaps this is what you meant, but not what was implied and more verbosity may help. It does not reference what you imply.
Oh, great oracle of oracle, knower of all and so on and so on.
Is one not a subset of four?
Did you listen on September 12 2020? The answer to this question is quite important to everything you spew
Can we take at face value anything verbalized by our leader?
Are you the judge of what is speculation and whether it is appropriate?
Whoot whoot! Love me some great speculation and cheerleading
Some people like to stick to just the facts please, others do not. Some people like to invest in safe and secure investments, others do not. Some people like to destroy innovation for the sake of $$$$$, others do the opposite. Some people like to judge others who have not harmed them, others do not.
What is the goal?...and are your assumptions correct? Do the timing of events matter? Does speculation help or hurt the cause? or is it just a lot of fun?
Heckling and bashing?
Cheerleading?
MHRA manufacturing certification? Why release this accomplishment, albeit quite minor relative to what is known and unknown? Is this cheerleading?
PI presentation of statistical model justification in April 9 2021? Do you think she rushed out immediately to present this model or was it complete several weeks earlier? What was the submission deadline and are these events related in any way other than an extremely interesting juxtaposition in time?
Why be asked to book 5 speaking events in the weeks leading up to a major conference whose platform would allow amplification of a ‘public release’?
Is scientific presentation public release or is it scientific publication?
Do all events contained in a process need to be outlined publicly? Biosect, I believe you just answered this one for me.
Are there advantages for partial release of information? What are they? Why now?
Is there great harm to investors if speculated timelines are missed or is the impact limited to traders? Should management or other investors care about traders on either side?
Do people name call to encourage or discourage others and does this have meaning?
Why would you skip ASCO, if your data analysis is complete and your SAB has been involved and your PI is clearly antsy and wants to build the argument? And your other PI pleaded with you for speed 2 years ago at said meeting? And publication will be positive news, but presentation then publication will be more positive?
There could be a reason for this just as there was likely a reason that your CEO said on September 12 2020 at another conference that data would be unveiled at the end of the month but later PRd a statement on October 5 2020 that indicated this earlier statement was clearly a lie. Is this speculation? Was it helpful or harmful? What did happen to the stock price and Did it serve a purpose?
Now with all do respect fine sir or madam, stick these questions in your ear, then your brain and then please do not judge me or I shall begin to judge you. Every single one of the letters you type. Comprende?