Replies to post #764623 on NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

LP has told shareholders indirectly that they expect to be busy addressing MHRA questions and that’s why they are not attending ASCO. That basically means don’t expect UK approval in Q2.

I actually believe it’s quite the opposite. It suggests that Northwest Biotherapeutics expects a positive decision from the MHRA very soon — and that they have therefore decided not to attend ASCO in order to fully focus on the final administrative steps that follow a marketing authorisation.

Once the MHRA decides to grant a marketing authorisation, they immediately ask the company to assist with the preparation of the UK Public Assessment Report (UKPAR). The company, in this case Northwest Biotherapeutics, must quickly provide a lay summary explaining the product in simple terms. Then, the MHRA finalises the full assessment report and sends a draft back to the company for factual review before it is published within 60 days of the licence being granted.

We publish a UK Public Assessment Report (PAR) for all new MAs. Once we have made a decision to grant your application, we will ask you to pre-populate a template with the lay summary for the PAR. Templates are available at Apply for a licence to market a medicine in the UK. You should use the template that corresponds to the legal basis of your application and submit via [e-mail]. We will complete the draft UKPAR supplied by you and publish it on the MHRA Products webpage within 60 days of grant. We will consult you on the text of the final PAR before publication

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https://www.gov.uk/guidance/national-assessment-procedure-for-medicines

Public Assessment Reports (PARs)
We publish scientific assessment reports called a Public Assessment Report (PAR) available for new marketing authorisations granted after 30 October 2005.
This is based on the MHRA assessment report with any commercially or personally confidential information removed

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https://products.mhra.gov.uk/

The Company is actively engaged in the ongoing process, and the Company has decided not to attend ASCO this year in order to stay focused on interactions with the MHRA and efforts to move forward as quickly as possible.

https://www.sec.gov/ix?doc=/Archives/edgar/data/0001072379/000141057825000598/nwbo-20241231x10k.htm#fact-identifier-753

UKPAR for Casgevy = 196 pages
https://mhraproducts4853.blob.core.windows.net/docs/9e1d2748cccfee159b5761cadbeea47e07ec6463

[martyDg]

LP has told shareholders indirectly that they expect to be busy addressing MHRA questions and that’s why they are not attending ASCO. That basically means don’t expect UK approval in Q2.