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well said absolutly correct
If there is one thing I have learned from being invested in NWBO is that NWBO does not give a crap about their shareholders waiting for news.
So no they are not telling us that they did not cause some sort of delay, as they did not make any amendments to the submission.
You are reading conspiracy into this.
They are saying that they didn't change the application because there was no reason to.
What people fail to understand is that literally months and months of delay have arisen from applications from other biotech companies that needed to be changed after the RA had dismissed the initial submission. NWBO wants to calm the market down by saying that is NOT the case here.
They have had and still have inspections all the time so that does not concern me. Our last ASM was Dec 23? 2022. Seriously they could have waited 2, 3, 4, 5 more weeks to plan the ASM AFTER they were confident to have received approval but they are now saying that they are planning an ASM end of June.
Its fair to say that NWBO always wanted to have the next ASM AFTER approval.
Nothing is sure in life but apparently NWBO is confident they will be granted approval by the end of June.
yes you are right NWBO is still preparing for inspections, but that could be very simple inspections that are already in the books where a few futilities will be signed off. Your evaluation of the results put together to a formal analysis bla bla is utter BS
Riddle me this bear. You have 2 to 6 weeks on this board left before you lose the approval bet. What will you do until that time?
You do realize after this 10Q that you are screwed right. You do understand that
Tick tock tick tock
I heard otherwise. But I hope you are right ofcourse. Anyway in that case 70 days from March 7 is May 17th or about.
Lets hope so
that is what it implies yes IMO
at least no questions of such state that they had to adjust the application (which btw would have caused months of delay).
I think (but im not 100%) that the first date is we (the MHRA) received the application in good order (Jan 24) so that's 1 month delay and later than we expected (dec 20)
and the second date March 7 is the MHRA went through the application and did not find any problem.
Now the question is. Did they receive an RFI.... My guess is IF the MHRA raised problematic questions NWBO had to adjust the application which they stipulated they have not.
so yes one could see Dec 1 until March 7 def as Phase 1
if ifs and buts were candy and nuts, we'd all have a Merry Christmas
he will still deny the UCLA DC vaccine = NWBO's DCVAXL
The only cemented that is good enough for a (license) deal, for a large pharma is UK approval.
Median follow-up of patients treated on this clinical trial was 2.2 years after surgery, although the long-term survivors have now been followed for over 10 years. Median progression-free survival (PFS) was 8.1 months; and median overall survival (OS) was 26.6 months.
median overall survival in present SOC for GBM currently is 9.2 months, that's an almost x3 improvement and counting
I think they already answered the questions asked in the RFI
You may very well be right about the buyout price. As I posted here yesterday Merck made (IMO) an opening bid for NWBO at $15 billion a few weeks ago
https://www.biopharmadive.com/news/merck-dealmaking-15-billion-keytruda-cliff-davis/706309/
100% agree. And yes I agree with you that at these depressed prices, LP will not sell NWBO. However, things can move very fast.. A large pharma making an upfront payment of $300 million for the right to sell DCVAXL in the UK on approval, SP to $4-$5 after approval, uplist SP to $ 7-$ 8 on Nasdaq. Rumors of buy out SP to $ 10- $12
Bam NWBO bought in .... December this year or Q1 next year.
The point I was making is of course that with a staff of 14 NWBO will not stay independent.
Also with NWBO's CTO residing 5000 miles to the East of NWBO HQ, no scientist at NWBO HQ (and no Dr Liau is not working full-time for NWBO). no medical trial experts working for NWBO....
NWBO is NOT capable of organizing even a Red Cross exercise let alone a new joint medical trial, let alone multiple medical trials.
They will be bought within 6-9 months after UK approval.
exactly. The Delaware court is not favorable of management screwing over small retail shareholders
yes you are right that the court has not made a final judgment but if you read what the Delaware court opinion is then you can easily see where this is going.
Trust NWBO when they say in their 10K/Q that DCVAXL needs to be A) marketed B) sold C) (most importantly) sales supported.
You cant expect MDs, caregivers, surgeons, patients etc to just start guessing what DCVAXL is, how it should be administered, what is needed, what is to be expected etc etc etc
Ooh and if you are talking globally now. Who within NWBO will be discussing reimbursement policy with the hundreds of insurance companies and governments in (after UK NICE) Canada, 27 EU member states, the US, Australia, Japan, South Korea, some countries in South America, Switzerland, Norway etc etc etc?
Les? Linda? I think not
NWBO will be bought
As I have said here a few times I think NWBO will be bought for a price between $15 billion on the low end
https://www.biopharmadive.com/news/merck-dealmaking-15-billion-keytruda-cliff-davis/706309/
exactly
NWBO will not be selling DCVAXL because they are not capable of selling, marketing, and most importantly sales supporting DCVAXL. Therefore there will be no revenue generated by NWBO as an independent biotech in the UK in 2025. Anyone who thinks a cancer drug therapy such as DCVAXL can just sells itself without any support from a well-prepared cancer drug sales support department does not understand the workings of biotech. As of today, NWBO only has Les's wife Sue Goldman to sell support the compassionate use of DCVAXL. The assertion that present NWBO/Sue will be able to explain, instruct market, and sell DCVAXL to 362 consultant neurosurgeons and or 1,078 clinical oncologists and 3,200 patients and their caregivers in the UK is absurd. As long as NWBO is not hiring a single qualified sales support staff they are not planning to sell DCVAXL. As long as NWBO is not hiring anyone to sale support DCVAXL, they are planning to be bought after UK approval.
From NWBO's last 10K
No its noy It's NOT 210 business days, its 210 regular days.