Totally agree, some folk just need reminding of what they own. Plenty of reasons to be positive about as we await the imminent MHRA decision.....
Thought for the day :
The UK MHRA Marketing Authorisation Application was submitted on the 20th December 2023.
They have had a very long time to find reasons to reject our application but have not done so to date.
1) DCVax-L was the first ever medicine to be awarded 'Promising Innovative Medicine' (PIM) designation by UK.
2}UK MHRA has allowed DCVax to be given to patients for over four years on a 'Specials' compassionate use program, despite not yet having MAA approval. No issues in terms of either Safety or efficacy have ever been raised.
3) DCVax has a totally 'benign' safety profile.
4) $nwbo was given approval (fast-tracked) of the Pediatric Investigation plan (PIP) BY MHRA which forms a pre-requisite for Application for approval of a New Medicine for Adult patients. Importantly, The external controls will be identified using the same methodology as was used to pre-specify the external controls in the Statistical Analysis Plan for the Company’s Phase III trial in adult patients.
5) DCVax successfully completed the first phase 3 trial of a systemic treatment in 17 years to show a significant extension of mOS in nGBM
6) DCVax successfully completed the first phase 3 trial of any type of treatment in 27 years to show a significant extension of mOS in rGBM
7) DCVax successfully completed one of the first, if not the first, phase 3 trials to show meaningful increases in the long-term tails of the survival curves in both nGBM and rGBM
8) DCVax is the 'Gift that just keeps on giving' 🤣
Plenty to be positive about as we await the imminent MHRA decision.
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