Replies to post #470281 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Is anyone thinking FDA will not approve based on using Historical Control Group? Or ask for another phase 3 trial?

I do not even expect NWBO to submit a BLA.

The patients randomized to placebo live longer than those randomized to DCVax-L. There is plenty of reason to assume the results were based on no more than "intent for near total resection" compared to other trials. Not exactly strong grounds.

If NWBO actually submits a BLA, the FDA could go nuclear and disclose LP's dirty underwear.

[CherryTree1]

Only those that manipulated today's price drop.
I really don't know what they are trying to do.
The truth is now out there and will only get stronger with the journal article.
It is clear that DCVAX works and works well.
The current standard of care (SOC) for GBM which involves surgical resection and radiotherapy with concomitant and adjuvant temozolomide (TMZ) was approved with a median survival improvement of 2.5 months I believe.