NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

sentiment, I agree with your timelines for the most part. The normal review period for the FDA is actually about ten months, but as you say, priority review can be six months. I’m very optimistic that once the data is revealed, that a lot of things are going to be different for Northwest Bio, and the new, shorter regulatory pathways will become available to DCVax. And while I’m also hopeful that much of the pre-BLA work has been completed, and that RTOR would be available, I’m not as confident about either of those.


CDER 21st Century Review Process Desk Reference Guide
https://www.fda.gov/media/78941/download

FDA & EMA Joint Report on Early Access Pathways
AUGUST 27, 2019

FDA recently published in coordination with the European Medicines Agency (EMA) a report from a joint FDA-EMA workshop with stakeholders on supporting product quality development in early access approaches (see the report and workshop materials here). Presentations from each of the speakers, panel and break-out sessions are also available.

More here: https://regulatory.parexel.com/regulatory-blog-2/fda-ema-joint-report-on-early-access-pathways

Stakeholder workshop on support to quality development in early access approaches, such as PRIME and Breakthrough Therapies

The aim of this workshop was to discuss scientific and regulatory approaches which could be used to facilitate development and preparation of robust quality data packages, to enable timely access to medicines for patients whilst assuring that patient safety and product quality are not compromised. 
Participants looked at specific industry case studies covering chemicals, biologicals and advanced therapies and experiences across different regions. 
EMA and the United States Food and Drug Administration (FDA) launched PRIME and Breakthrough Therapy schemes to strengthen their support to the development of medicines for unmet medical needs to help patients to benefit from these therapies as early as possible. This workshop is a joint collaboration between EMA and the FDA.
EMA has published a report on the workshop, containing recommendations from participants on next steps and areas to be further explored by EMA and the FDA. 

https://www.ema.europa.eu/en/events/stakeholder-workshop-support-quality-development-early-access-approaches-such-prime-breakthrough