Replies to post #667555 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Crickets.

[The Danish Dude]

Ex couldn't find sources about DCVax-L being ATL-DC in UCLA combo trials even though he was provided and spoonfed with them daily.

He needs an incentive for reason ...

[biosectinvestor]

Excellent post by Hoffmann, though generally I would not go off of a case for those timelines, even given the letters. But I think the timeline is reasonable in terms of the way he laid it out. You can derive much information from case filings though. As for the timing, the challenge is ultimately that the variables are so flexible, so it can happen even very rapidly if the regulator is very satisfied with the application. It is very reasonable to expect a decision this year.

It is clear though that the Phase 1 assessment can go as long as 80 days or even be faster… it is “up to” 80 days. If there are substantial questions and I do think those types of questions tend to be, then the clock off period might likely take the full 60 days or close to it, but that also can be shorter, or longer if it requires that, but I think more likely around 60, to ensure thoroughness of a response. Such things do not necessarily turn around fast when so much is riding on the answer and not missing anything. And of course, that period might not happen at all, further making it very difficult to estimate. The regulator could be very satisfied with the application package.

Then you have 150 days minus the time for phase 1 (and the clock off period), for the last phase. That is somewhat of an indeterminate period, not in maximum length but speed. Assuming it takes the full period, as he suggests, you look at these variables and you can really get a wide range of decision dates. As H suggests in his staggered timelines.

The initial validation generally happens though, as I said previously, during the pre-submission process using the MHRA’s systems. It is basically presumed valid unless they find something glaring and that Phase 1 period is when most questions are going to come up, so I expect anything reasonable would come during that part of the process in reality.

Here are some further relevant sources:

“Guidance:

150-day assessment for national applications for medicines

Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.”

https://www.gov.uk/guidance/guidance-on-150-day-assessment-for-national-applications-for-medicines

“Guidance for new Marketing Authorisation assessment routes in the UK following Brexit: 150-day National Procedure”

https://www.lightning.health/news/guidance-for-new-marketing-authorisation-assessment-routes-in-the-uk-following-brexit-150-day-national-procedure/


People may find those sources most interesting.