Replies to post #647789 on NorthWest Biotherapeutics Inc (NWBO)

[supersteve13]

I’m not making any claims about % likelihood- I’m wondering why you’re pointing to FDA numbers when responding to a post about MHRA acceptance odds. Just seems like a strange thing to do. :)

[supersteve13]

Can you excerpt the portion from that link that you feel is germane to this conversation? I didn’t see it at first glance.

[The Danish Dude]

No I am not. I am stating my belief, which I can back up with arguments and which I have always done regarding MHRA. Don't waste my time stating I make things up on the spot. I have posted abundant evidence of whats going on in MHRA and why I believe MHRA approval is a "gimme". If you wan't your fud to "succeed", find a rookie.

And 68.72 of all statistics are made up on the spot. You are lying

As Steve wrote:

Why are you using FDA numbers in response to a post about MHRA approval chances? :)

Ok fair enough so let’s be clear, do you believe the 99% number too?? Are you going to say fda nda is not the same as maa as far as percentages?? I’d believe the link below over an anonymous poster. This says all 3 are the same/similar. 99% is a made up number. Show me where 99% chance of maa approval after p3 trial. You can’t. There’s not even a 99% chance NWBO will submit at this poi

https://www.allucent.com/resources/blog/how-form-clinical-pharmacology-strategy-your-nda-bla-or-maa

I will show you, WHY I believe, there is 99% chance of MHRA MAA approval. Let's start with the essential.

Every approval of a drug is different. So what is it, that sets DCvax-L apart from other drugs, and makes it a 99% chance of approval?

Basicly a decade long cooperation with MHRA:

1) DCVax-L earns the first PIM designation for a drug. As was announced;

"his PIM designation is the first crucial step in accelerating access to new medicines, giving real hope to patients and their families
- Life Sciences Minister George Freeman.

2) From that, sprung the compassionate use case, So, DCvax-L was believed to be safe. According to Les Goldman around 470 patients have been treated under this program since it started, so safe to say, MHRA have quite much data about this.

3) The MHRA have had a decade long cooperation with NWBO and DCVax-L and during THIS year, they’ve announced new policies, regulations, processes and more, that in themselves center around cancer vaccines, faster approvals timelines for MAA application and the use of new technology equipment (ATMPs) where patients are. Point of Care. News that support the notion of MHRA preparing for DCvax-L approval.

You can find that pointed out ind details here

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=172735939





4) The results of the combo trial with poly-iclc to be published in Nature, could positively influence the outcome of approval.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173132343

5) British politicians from the All-Party Parliamentary Group on Brain Tumours, SPECIFICALLY pointed out in the Pathway to a Cure report announced in February, for MHRA and NICE to approve and reimburse DCvax-L. The politicians specifically want MHRA to endorse the use of historical controls.

The recommendations:

[supersteve13]

Hey legend which part in this link you provided were you referring to? :)