“Who cares what you say”? You are an ignorant poster not providing links to your own assertions giving an alternative definition of established medicine in your last sentence.

See:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173967586

See:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173967586

Also: see:

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173967586

George Bailey said:

“Extremely rare” is my point.

Not my point.

Sounds like you have not read the latest on National established medicines. MHRA wants to get to determination after initial assessment. If your argument were true, they could not do that because initial assessment would not cover everything. Moreover, if there is a “complete” response to the rfi (if one is issued after initial assessment), it goes to determination, not further assessment.

I just sorta scanned the nt-10ks. This is the first one Les signed. I don’t recall him signing any other 10q or 10k either. I could be mistaken.

I could be wrong, but I think this was the first
Nt-10k Les signed instead of LP.

DD was speaking about the phase I study, I believe. You are discussing the phase II study.

Hmm? Wasn’t thinking of you at all.

But if your quote today below is you “defending” NWBO, I’m glad they have Cofer and Posner as backups.

The material weakness is a nothing burger.

What’s funny is that they needed to go with the “Monte Carlo” valuation method.

Only on Wall Street.

So, correct me if I’m wrong, but it appears, and I don’t mean to speculate too much here, that the nt10k was filed on Friday, March 1, 2024.

This also means, and you can drop me in a vat of two buck chuck if I’m wrong, that NWBO filed as a large accelerated filer.

Oh, it also means they did care about following SEC rules.

It’s still Friday there as well.

It’s still Friday where I live.

Says the basher who thought nothing was going on between NICE and NWBO. SMH.

NWBO was a listed sponsor in the Phase I DCVax-l + poly-iclc study.

You overstated/mistated most of what I said.

Because linking the relevant entire tweet was considered off-topic by admin.

Hope this isn’t off topic.

Apparently NICE has been working with NWBO recently, and NICE anticipates an update on the topic webpage in the next week or so.

Source: NICE response to Alphavestcapital.
February 29, 2024

https://en.m.wikipedia.org/wiki/Ten_Minute_Rule

Recent movement. (Update)

1. Combination patent application in Europe to be granted, includes both DCVax-l (lysate pulsed) and/or DCVax-Direct (partial maturation) with checkpoint inhibitors.
2. 72 days since MAA was filed.
3. MHRA and FDA looking at further cooperation.
4. Nature Journal article on DC/poly-iclc combination study nearing publication. Primary completion date for study occurred nearly thirty days ago.
5. Active negotiations with other parties for combination trials going on for over a year, awaiting MAA to be “cemented.”
6. Large pharma struggling to adapt to upcoming patent cliffs.
7. Cohen/Milstein/Posner about to file second amended complaint, and with it, formulaic method to arrive at loss causation.
8. Flaskworks (aka: NWBO) continues IP momentum.
9. Advent hiring head of production to hire team to facilitate biotherapeutic production for clinical use. (Direct?)
10. FDA pursuing Promising Pathways.
11. Apparently NICE has been working with NWBO recently, and it anticipates an update on the topic website in the next week or so.
12. The End Brain Cancer Initiative (EBCI) Advocates for DCVax®-L to Gain FDA Approval
13. 10 Minute Rule Bill passed in UK for the 3,200 people who are diagnosed with a glioblastoma brain tumour every single year

FYI

https://www.globallegalinsights.com/practice-areas/pricing-and-reimbursement-laws-and-regulations/united-kingdom/amp

I’ll have to write them as well since you are not going to answer what your precise question was.

I did not say a partnership deal was already done, but I did state that NWBO intends to proceed with financially beneficial trial combos with several parties once the maa is “cemented.” According to LP at December 2022 ASM. Read the transcript.

I’ve already responded to your misworded second question multiple times.

I was incorrect on your third question. One does not always need to file an MAA before a commercial MIA is granted. However, I was right that Advent utilized the DCVax-l manufacturing process to prove their facility was entitled to an mia.

What was your precise question?

Correct, there may or may not be an RFI issued. The company stated just after submitting the maa that they anticipate an RFI will be issued, probably because that is most common.

What was your precise question?

They don’t have to PR if there is an RFI, as far as I understand. If there is one, it could be easy, moderately hard or difficult to respond to. Meaning, they might need a few days, a few weeks or the entire 60 days to respond. If an RFI is issued.

I think we (longs) are all hoping there was good coordination with regulators through our consultants prior to submission. This coordination is suppose to be easier because this is an orphan indication.

Because you need a response to start phase ii, so they can conduct their assessment of your response. However, if no issues, no RFI and therefore if no response, you can’t start phase II assessment, because the assessment is complete. Therefore, determination. IMO. See my prior points from today for more.

No. I’ll stand on my points from today.

And RFI’s are not always “necessary.”

Poor thing. Always evading reason.

Newsflash, everyone except apparently you has known about the possibility of 60 days clock off for quite some time. But it’s amusing to see you think otherwise.

No, I’ve explained it to you. You simply don’t understand logic.

If an RFI response assessed in Phase II meets all issues raised in phase I it leaves assessment, because it is “complete,”and goes to determination. (According to the recent MHRA newsletter and link on established medicines)

If an RFI was never issued because no issues were raised by MHRA in phase I, then it is “complete” and needs no further assessment. Meaning it would go to determination.

Imo.

You are just repeating yourself. Go back and read my arguments. Read them all. Don’t pick and choose.

Long story short. You and ex think this has to add up to 150 days of assessment. It does not. It can be less. In some cases far less. In some cases no further assessment is done after phase I, just determination.

It’s sorta like:

Prior to JAMA, shorts thought they were playing chicken against a ford fiesta.

After JAMA, shorts thought they were playing chicken against a Camry

After submission, shorts think they are playing chicken against a Ford f-150

After March 21, shorts will think they are playing chicken against an 18 wheeler.

You simply can’t respond to reasoned argument with facts. So you just say stop making stuff up.

Here is your game. You want a vulnerable window where shorts can attack without fear in hopes that you can buy cheaper.

There is no vulnerable window. Time has matured such that many things can occur, and in a couple weeks, the possibility of early approval will be included in that window.