iovance therapeutics yes
aesop mentioned it, I was just curious what he was talking about :)

You daredevil you

DCVAXL is the only drug out there that has that can exhibit a unique mechanism of action with a great safety profile that has been tested in GBM and will be approved for nGBM and rGBM patients.

what was your point?

https://www.iovance.com/clinical-pipeline/ study the pipeline and then form your opinion

there is more in the IMMU world than GBM trials. Applause yes you made it clear that you have read that NWBO conducted the only successful GBM trial but thats not the point that was made.


NWBO market cap will not be higher just because it has a successful trial for GBM

For a biotech with FDA RMAT designation for Melanoma so in the stage of approval and FDA BTD Pivotal for Cervical cancer and a current 5 combo trials running, I find their market cap of $1.7 billion ridiculously low.

Do you know why that is?

aesop,

what is the name of the other autologous you wrote about? Thanks

Exactly

The waiting for Eden before approval argument is ridiculous and absurd

I know I know. Its terrible

My kids love tortoises but not when you call them NWBO

its mind blowing yes.

I agree with you, however, in the case of the application NWBO did update shareholders in their last 10Q they are delayed.

exactly as they have said in the 10Q

"The Company is hopeful that the various backlog circumstances will improve in 2023"

That's 100% correct. Only approval or rejection by the RA is a material event.

I also NWBO believe does not want to give a timeline because they depend on third parties for the completion of the application such as the clinical trial sites, the CRO, the third-party consultants and of course MHRA itself.

The BS excuse of the self-invented "Post-COVID difficulties" NWBO provided is however incredibly lame and has a white beard. A more up-to-date believable excuse would have been staff shortages.

That depends if the MHRA is asking for information/asking questions they could not have known before and which they had/have to go back to the trial sites for to get it (which I think happened here given the rolling review) then I disagree.

If its information that its more or less standard belongs in the MHRA application then it would be incredibly amateurish if they had to go back to the trial sites to get that data.

Either way, the "post-Covid" delay excuse which they are now trying is incredibly lame and I agree with you that NWBO is the slowest turtle in the snail classroom.

Btw if each RA especially the FDA has its own specific request for information they have to go to the trial sites for then we are in for a very long wait after MHRA...

I never said they didnt say the RA has a backlog. They did say that AND they said the trial sites have a backlog.

From the 10Q

So you saying this ". It has nothing to do with waiting for additional details from trial sites." Is made up and BS


Read what I posted before

From the last 10Q in my view, they made it pretty clear where they are in the application.

1. "The Company is working with teams of specialized consultants on pre-requisites for the application." And what are those pre-requisites for the application then? well

2. "The clinical trial site backlogs involve delays for various clinical trial follow-up matters, such as queries and additional documentation".
A. So the company here stipulates what the "pre-requisites" are for the application. Being "clinical trial follow-up, such as queries and additional documentation"
B. How I see it they could never have known what queries and additional documentation they need for the application if they had not been provided this request by the RA (MHRA) via a rolling review.
C. Also they clearly are saying they are delayed providing this information to the RA because of "Post-COVID difficulties continue to impact the Company’s programs and operations" (Which personally I find a huge BS excuse)

3. Then NWBO gives a timeline for when they expect these backlogs to be solved and thus when they can provide the RA MHRA) with the requested info
"The Company is hopeful that the various backlog circumstances will improve in 2023."

well they did say this

but then 5 sentences later they say this
"The Company is hopeful that the various backlog circumstances will improve in 2023"
...In 2023 pff

From the word salad 10Q, I got the impression they are waiting for the last details from the trial sites before they have completed the application. Would it take many months in 2023 before the CRO/ trial sites are able to provide the requested "trial follow-up matters, such as queries and additional documentation"?

I just cant imagine

Btw I didn’t mean to say that I don’t believe what DI told you. It’s not us it NWBO management. Les has BSed many things over the years

A fun fact is that Les told my friend that they only would PR the ACCEPTANCE of the (rolling) application submission. The reason is that the if they would PR they have now submitted 100% of the application and then get rejected for some small details or unclear information they would have to PR that again. Also, they did not PR the submission of PIP but only the acceptance of it.

From the last 10Q in my view, they made it pretty clear where they are in the application.

1. "The Company is working with teams of specialized consultants on pre-requisites for the application." And what are those pre-requisites for the application then? well

2. "The clinical trial site backlogs involve delays for various clinical trial follow-up matters, such as queries and additional documentation".
A. So the company here stipulates what the "pre-requisites" are for the application. Being "clinical trial follow-up, such as queries and additional documentation"
B. How I see it they could never have known what queries and additional documentation they need for the application if they had not been provided this request by the RA (MHRA) via a rolling review.
C. Also they clearly are saying they are delayed providing this information to the RA because of "Post-COVID difficulties continue to impact the Company’s programs and operations" (Which personally I find a huge BS excuse)

3. Then NWBO gives a timeline for when they expect these backlogs to be solved and thus when they can provide the RA MHRA) with the requested info
"The Company is hopeful that the various backlog circumstances will improve in 2023."

In 2023.......

this did not age well either

flipper44 July 21
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169463365

I quoted NWBO saying this
Such a manufacturing license is separate from any regulatory decision about approval of DCVax-L itself
Then you said this
"Separate certifications do not mean one is not dependent on another."
https://investorshub.advfn.com/boards/replies.aspx?msg=169465773

It turns out they are independent of each other MIA from MAA and MAA from MIA just for the awarding of MA itself the biotech company needs a MIA-certified CDMO.
This is the discussion I had with you in July 2022

You are confused of what you said. You claimed MIA is a prerequisite for submitting the request for MAA which turned out to be incorrect.

Peanabutter Jama for one.

Im predicting, as I have for months, NWBO will be bought after MHRA approval

you do hopefully understand that when I said DCVAXL will be sold online as a webshop product I was joking? The perhaps was a clue?

OMG Everyone knows patients do online research. Everyone medically researches everything online always. There is no one on the planet who has not done medical research for himself or for a family member.

look if NWBO wants to stay independent they will be needing a staff of at least the same size as Novocure which is around 1300. NWBO has 16. It took Advent 2 years to get from 4 to 60 staff which equates to around 2.5 staff per month. If the average 70+ years in age management wants to hire 1285 staff at the same speed as they did with Advent then they will be needing 514 months = 42 years after FDA approval to get to the same size level as Novocure and be really a medium size independent biotech company

Good luck with that

I didnt know DCVAXL will be sold online as a webshop product.
Well in that case LP 100% still has a lot of work todo to create a great website webshop ;)

The market will only start incorporating a buyout of NWBO AFTER MHRA approval has been granted not before.
NWBO's low market cap is due because of lack of confidence in NWBO being able to execute milestones in a timely manner and doubts that ECA will be accepted and of course the lack of any speculation in non revenue biotech stocks given the interest rates hikes.

nope they will be acquired (thank goodness). You asked for the why. I have posted about the why here many times.

Why would LP scream at the top of her lungs that NWBO is for sale? That would be ultimo dumb if you want a good price. She also said this

And as we said last year, if we were to get the proverbial 'offer you can't refuse,' we wouldn't refuse.

So pick your pick in what she said

Not only that but the idea that only 20 sales peoples need to be installed and the sales is a done deal is a naif dumb remark made by Powers. If you start from scratch without any contacts, years and years will be needed to present your new high-end medical product to hospital committees and MDs with a staff of hundreds not only in sales but also support.

Novocures employs a staff of 1250 people! NWBO 16
https://www.linkedin.com/company/novocure-inc/people/

why dont you quote the rest of the Freedom of Information Act being the decision
https://ico.org.uk/media/action-weve-taken/decision-notices/2023/4025017/ic-195519-t0x4.pdf

Given the decision of the committee your conclusion "Looks like somebody is planning another derivative suit saying that LP is spending NWBO cash on Advent." Is BS

Yes, the mystery of why no, CMO/ CSO, CFO, or CTO is hired and why NWBO fires its PR company has now been solved. The reason is that NWBO will be acquired most probably after the first approval is in.

How naive was Linda or better how naive did/does Linda think her shareholders are to believe that you just and only need to install 20 salespeople and DCVAXL in the US is sold?

Bingo give me a break.

Its these dumb remarks that assure me that NWBO will be acquired probably after MHRA approval.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=168262651

What you are discounting from the equation is that Linda chose to build her own personal CDMO first. They could have continued with Cognate CRL as their certified CDMO and conclude the timeframe for approval within 1 year after datalock but Linda decided that Toucan needed to have its own CDMO paid by NWBO shareholders .

What’s done is done and here we are now with Toucans Advent as NWBOs MIA

So in other words you were wrong.. again

I guarantee you to be wrong on this one. They are very close. I would not just say that if I didnt know for sure

Als the combo trial has little to no influence on the request for approval for DCVAXL

Thankfully we will never meet.

Yes we are really close

Good grief is a better response

They will PR when the MAA is accepted not when its submitted.
the reason is, if they submit and then its rejected for reasons of some small details, then they will have to PR that again which probably would invite lawsuits.

This is at least what I have heard.

Why are you looking fo a dance partner? ;)

for cash-strapped NWBO it would make perfect sense.

There is vivid trading in claimed damages in the legislation industry, you should know that.

ex even you have to admit that when to me and if for you DCVAXL is approved (FDA, even MHRA) large big pharma's will want to buy NWBO.