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XMaster2023

07/14/24 10:46 AM

#705942 RE: exwannabe #705940

There is no serious issue with trial approval or you would never have 73 coauthors putting their reputation at risk. You have no credentials and no reputation being an anonymous blogger paid by one of the 7 Market Makers or BP. People should put you on ignore.
Bullish
Bullish
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Doc logic

07/14/24 10:58 AM

#705945 RE: exwannabe #705940

exwannabe,

The issues with the ECAs in this trial are at least partially overcome by the clear effect on survival in rGBM patients. This is especially true in elderly patients who were generally given lower doses of chemo or removed from it completely because of intolerance to it. When this observation is taken into account all the other comparisons make
more sense, even in light of the fact that there is no patient level data which is at least partially due to comparative trial patients not having it available.
As to Flaskworks readiness I agree that the likelihood of early readiness is very remote considering the 18 month outlook given by Linda. On the other hand, the first GMP unit installation could be in months and approval of L using artisan will likely be within months. Marketing approval sets in motion the set aside reimbursement funding applications and immediate patient demand. There may even be a backlog from existing patient tumors that have been stored cryogenically. Sure would be nice to know when that starts to happen in earnest as that would be a hint that Dr. Ashkan believes that approval is within sight of creating an effective treatment before recurrence that will be accessible for his patients. Best wishes.
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dennisdave

07/14/24 11:40 AM

#705955 RE: exwannabe #705940

LL herself has talked on the video from last year as she notes RA want patient level data for EC comps.

All detailed patient data has, of course, been provided to the MHRA by NWBO. So what is your problem here exactly?
Over and over you keep repeating the same nonsense. The non-existence in and exclusion criteria problems, that you and some others have made up, have been tackled extensively when comparing DCVAXL patient data to EC comps.

And goes on to say how she hopes -L can be made available by some kind of RTT while studies are run to prove the OS benefit.


LL never said. She could not have said that because there already is an extensive RTT in the UK its called compassioned use.
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drugrunner

07/14/24 1:05 PM

#705966 RE: exwannabe #705940

Funny how Advent / NWBO are prepping for more hiring,approval and mass distribution and you are pretending more trials are needed

NWBO will be approved based on DCVAX 13% vs 5 % SOC

THOSE ARE FACTS