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Thursday, November 16, 2023 6:19:33 AM
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:
