Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Are you saying that NWBO is funding UCLA doing the combo trial with Merck Keytruda? Then why don't we see the PR for it? I am confused.
Thank you, make sense if UCLA can produce the vaccine as well. I thought it was not an easy task.
If NWBO is in the combo trial, would they charge whoever is doing the trail with the vaccines they supply to them? How many total patients need vaccine? That is not small revenue I hope.
Well, there's a first time for everything!
They said the "gut' is human body's second brain, controls your happiness, not your money.
I invested in KITE and JUNO, went through both buyouts. I didn't invest in BLUE which is still there. Pretty lucky.
So they announced the big news on the weekend. Who said that the news on a Friday is always a bad news?
Next news I believe will be the expanded manufacturing facility is certified.
1. Could the TLD be bad?
If it was bad and they hold it for so long, they are begging for lawsuits. Not possible.
2. Why they hold the TLD for so long
After the TLD, next step is to submit BLA. Without volume production facility, they can't submit the BLA or they will fail the FDA approval for sure. So rather than announcing the TLD and waiting for 1 1/2 year to build out the facility, they decided to hold the TLD until facility is completed. Waiting for publication is just an excuse for holding the TLD, publication itself is not a must have for submitting the BLA.
Now the facility is ready, no more show-stopping issues before submitting the BLA, everything else is just icing on the cake, like patents, publication, etc.
They may choose to hold the TLD a little longer so they can maximize its effects.
TLD is any day now.
I believe the reason they delayed the TLD is because they didn't have mass production facility available 1 1/2 year ago. Now after 1 1/2 year's hard work, the facility is ready, it is the time to have TLD and submit the BLA thereafter.
need to add patent awarded?
$6! Woof!
OK, so it is to retain "buyer's" investor.
the buyer wants to delay announcing the buyout so to keep investors interested in the near term approval.
That makes a lot of sense, thank you!
You are saying that if the TLD results are good, they can start to treat patients with compassionate use without FDA approval?
With $200,000 price tag, it is possible 100M revenue. not too bad. After FDA approval, the price can go higher.
I see, thanks!
The manufacturing capacity is only 500 patients per year, with $200,000 per patient then, it is 100M revenue. This assumes that we have enough demand, don't care who pay for the price. Where is the high SP prediction coming from?
With 500 patients per year, $100,000/patient. The revenue is only 50M. What did I miss?
$6!? Woof!
Can't believe it is green today, someone is not doing a good job!
If CVM designed the trial only to measure the non Chemo group for the primary point to start with, does that mean that we should be over $100 by now?
For them to get the non Chemo group, they will have a group of patients with Chemo with or without taking Multikine. What are they going to do with this group, discard it or monitor it and do a comparison?
They did latter and set out two primary points for the trial.
Although the group with Chemo didn't work, but it did verify that it is the multikine made the difference in the first group because if Chemo destroyed it, there is no effects.
Make sense?
From year 3 to year 5, the survival rate is going down respectively, but with multikine is going down slower than without, so the difference between two group survival rates is getting larger.
Not exactly, there is other arm and dropouts.
I kind of heard 380, did anyone hear the number for the group with chemo?
When 298 events were reached, not everyone was at 5 year or beyond. So the group size is smaller. The number of death in low risk group is smaller. the high risk group number therefore will be larger than you thought.
How many total patients in the high and low risk group who is part of calculation? is it 784 at least?
This 40% number is critical and can change everything. In engineering term, garbage in garbage out. However the thinking process is great.
I remember there is a third arm.
I saw similar price action when KITE was BO.
It will be crazy if FDA not approving Multikine, especially there is no new drug in this field in last 50 years.
With no bad side effects, Multikine off label usage will be like supplement pill.
Can the biopsy determine the high or low risk?
But there is a potential to replace chemo if multikine has better improvement. So may do it in future trial.
There are two groups of patient:
High risk group, which need to take chemo. They did with or without Multikine within this group, the results are no improvement, consider 0% improvement.
Low risk group, which don't need to take chemo, they also did with or without Multikine within this group, the results are 14% improvement @ 5 years. They will apply for FDA approval for this group.
They didn't give out the group sizes, but P value has some indication.
Within high risk group, they didn't do Multikine + no chemo vs no Multikine +chemo. This comparison will show whether Multikine is possible to replace chemo or not. They may do it later after Multikine is approved by FDA.
If Multikine gets approved by FDA, I can see many patients will choose Multikine over Chemo, or take Multikine first even when they plan to take Chemo late, there is no bad side effects, why not. Chemo take or not, can be decided when the time comes.
Almost not possible to lie about the 50% number publicly.
On top of that, multikine's way to enhance the immune system is a correct way to do, not anything as long as enhancing immune system will help treating cancer. This shows how significant it is.
Why not use it on other cancers since it has not side effects.
Chemo destroys immune system which makes Multikine not working. It actually proves that Multikine does enhance the immune system and enhancing immune system to treat cancer is a correct way to do, 14% improvement without side effects.
Apple to Orange
Next Monday morning anything can happen, better be ready than sorry!
Nice find!, the video is in 2020.
CapHill- Thank you for the information. I have 10+ patents and never took that long. However my patents are all in the engineering field.
I never heard about that you can delay the patent approval process for that long.