Replies to post #583545 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Another excellent post.

[exwannabe]

Let us compare and contrast these as they play out.

For Vertex's exa-cel I expect it being commercially available in the US followed shortly by Germany and much later in most other EU countries and the UK.

Vertex gave plenty of information on the submission process and schedule. They announced last year they planned to file by EOY 2022. They announced the rolling review was in progress in the US. They announced ILAP, Prime, RMAT and Fast Track

NWBO has announced they scanned a million pages

[JMarv]

Awesome post. Definitely something to watch and think about. Thanks Hoff!

[ATLnsider]

Excellent research hoffmann6383

[JTORENCE]

hoffmann6383 Good one thanks.

[CrashOverride]

Great job Hoffman.

I wonder if all of the shorts do such rigorous comparative analysis before spreading lies about Northwest Bio?

[Legend431]

Good post. Look at all Vertex PR’s. They pr submissions even hoffman. I was under the impression by your previous posts that you said companies shouldn’t or don’t pr submissions (can’t remember which)

What are your thoughts on that now seeing how vertex handles this. I believe this is relevant since you think they are taking the same paths

[Lykiri]

Excellent post hoffmann6383.
Another interesting similarity:

In preparation for the launch, Vertex has established a supply chain, including buidling needed manufacturing capacity, Arbuckle noted.

https://www.fiercepharma.com/marketing/vertex-teases-launch-plan-first-crispr-gene-editing-therapy-ahead-fda-decision

[Lykiri]

DCVax-L in the USA

FDA Submission process: Orphan Designation / Unknown (Real Time Oncology Review, imo)
BLA Submission date: ?
BLA Acceptance date: ?
BLA Approval date: ?

hoffmann6383,
Real Time Oncology Review (RTOR)
I doubt it.

A July 2022 draft guidance on RTOR states the program “may not be suitable for certain biological products, such as cell and gene therapies, for which complex manufacturing and product characteristics need to be considered in evaluating the safety and efficacy of the product.” (Also see “US FDA’s Real-Time Oncology Review Program Is No Guarantee For Early Approval” – Pink Sheet, 27 Jul, 2022.)
When asked about the prospects for extending the RTOR philosophy to CBER, OTAT’s Bryan noted the complicated nature of gene and cell therapies could pose challenges.
With OCE’s RTOR program, “there’s a bit of cherry picking” in that the most complicated products are excluded, he said.
“You don’t put the ones that have CMC manufacturing issues into Real-Time Oncology Review. Now maybe that will evolve. So we have to find things in cell and gene therapy that aren’t complicated, that don’t have great manufacturing issues. And I think we’ll be doing that with some efficacy supplements, but probably not original BLAs for some time.”

https://friendsofcancerresearch.org/news/pink-sheet-us-fda-eyes-project-orbis-type-approach-for-cell-and-gene-therapies/