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exwannabe

07/14/24 10:26 AM

#705940 RE: XMaster2023 #705939

The Journal Article indicates DCVax-L achieved Statistical Significance in rGBM and nGBM. First trial in over 2,000 or 27 years to do so


Yes, it was stat sig against the ECA. Alas that has serious issues wrt approval as has been discussed here many times.

The paper notes one huge point, lack of patient level data. LL herself has talked on the video from last year as she notes RA want patient level data for 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.

And no, it did not say the "first trial ..." line. That is just spin longs on this message board make up.

Flaskworks 3.0 a closed manufacturing system will be approved within months


Can you not understand what LP said on this, or do you think she was laying a trap?

They are still designing tweeks and when done will order initial units. They have said once that order happens it may be delayed by supply chain issues. Once they are in they house (which may not be this year) NWBO needs to perform internal runs to see if it checks out. After that they need to perform the comparability study. Then they submit for approval, and that is not a pro minor step for commercially approved drugs.There s no commercial Flaskworks in the comigng months.