Replies to post #385483 on NorthWest Biotherapeutics Inc (NWBO)

[Dr Bala]

Absolutely. DCVax-L will beat the statistics of the currently approved therapies by a wide margin. LP mentioned that she would like to see this therapy become the future SOC for GBM.

[biosectinvestor]

Thanks for collecting that all together in one post ATL. Really helpful!!

[beartrap12]

ATLnsider,
This is a great collection of quotes on DCVaxL and its tremendous benefit to the overall group of GBM patients, including the crossover, right from the mouths of the experts. No need to read posts by armchair doomsday predictors who have no shares in the game.
Thank you for all your work here for this board. I love reading your posts!!

[erik007tc]

Excellent!!!

[Kam8]

Fantastic ***

[eagle8]

Thanks for this post.

Nice summary of the various opinions (Liau and Ashkan) based on the 2018, blinded results.


Best to you

[Mionaer1]

Great. Thank you.

[flipper44]

You posted:

Dr. Richard Pazdur says the following around the 32:00 minute mark, regarding the reasons why the FDA started Project Orbis:

This has some important aspects in oncology, we really want to have a global standard of care, and when you have a truly important “Breakthrough therapy drug, it is important that it has relatively widespread worldwide distribution and approval as soon as possible because that becomes the new standard of care, and subsequently the new control arm for subsequent trials
https://collaboration.fda.gov/pbq6126oijaa/

My thoughts below:

If Orbis applies.

So this might explain why it wasn’t enough to simply have Cognate ready. It would explain the wait for Sawston. The development and acquisition of Flaskworks. The earlier development of Cognate, deep pockets like Black Rock resourcing large expansion, and it would explain the acquisition of Cognate by an even more international company, CRL, with global resources. This summer, Advent is already planning/preparing post approval expansion by closed system manufacturing, utilizing, amongst other things, Flaswork’s patents.

Meanwhile, the compassionate program continues.

If Orbis applies here, then Dr. Pazdur’s commentary about widespread distribution capacity and approval as soon as possible explains the way LP has been addressing investors with her eye on expansion capability.

While the initial launch would necessarily include manual manufacturing, the emphasis on it being followed very closely by expansion/automation makes a ton of sense. This summer, they’ll start running/testing/validating Flaskwork’s improved manufacturing technology for post approval transition. If DCVax-l is approved earlier.

I can’t see Dr. Pazdur’s agency wanting a drawn out transition to automation and international distribution for the very reason (in part) he gave in the quote above. This then would explain some of NWBO’s behavior.

[Hopeforthefuture3]

ATL, again good links. Don't know where you have seen it (dcvax) should only be approved for subgroups but I don't read all posts. I do go with the data presented that it probably works in 25-30% but does no harm so why not try on all. The Liau Seattle Science Fountain presentation at least 5 time she speaks of the 25-30% including her conclusion slide. She does say all seem to be doing better and attribute that to potentially an impact to the crossover - dcvax early vs dcvax late. All her actual presented and published data does point to the 25-30%. In the information arm she talks of the 25 of 45 probable pseudoprogressors and they do pretty darn well. The 20 confirmed progressors do not. Would one day like to see the data on the confirmed pseudo group of 32. Also would be good to see the genetic groups of the 45 info arm group, wonder if we will ever know. (Have watched this Liau presentation dozens of times and we come to different conclusions)
Ashkan is definitely in favor but wonder if he is looking at it more as a clinician wanting something for his patients rather than as a researcher. In latest Ashkan presentation seemed he may not but totally informed on current trial status.
Imo data at that point (interim blinded paper) was probably good enough to go for approval.
After the Ashkan talk youtube list came up with a interview from August 2011 with Powers in which she spoke of results in 18 months to 2 years - still waiting...
On cvm board this morning was a link to an 11 year old boy in England with gbm trying to raise funds to get dcvax. Imo should have been approved by now to potentially help such people.
Ucla is trying (among other treatments) combo with dcvax so pretty obvious to me trying to find way to help a larger % of patients.
I think it should be part of soc as at worst it does little/no harm and imo helps at least a good %.
Guess we just have to wait for final data and paper to find out the real outcome. In meantime I will continue to believe the data as presented and published
Luck to patients