Replies to post #211239 on NorthWest Biotherapeutics Inc (NWBO)

[Andy2018]

Ohh great then it’s sure shot FDA approval. So why FDA want more OS instead approving AVEO drug based on pfs like you many bash here for dcvax PFS.

[Virgilio]

I understand what you mean and I agree, once you reach primary endpoint there's IMO no need to leave it blinded.

[abeta]

iclight - I got your back - buddy

I have said

for years and years and years

(to myself) .....

The STIFF that goes in the ground with a higher PFS
is a MUCH MUCH happier STIFF ....

than the STIFF that goes in the ground with a lower PFS

It just makes sense .....!

Additionally - though I can't prove it - there may even
be a post STIFF scenario in which - you know who -
gives bonus mileage awards for those STIFFS who experienced
a higher PFS result - but terminated anyway.

What's not to like - if the story is true ...

IC - BEWARE -

There are PFS PULPIT THUMPERS a foot -

spewing spewing spewing - (perfect example)

The FDA, by law, is afforded flexibility when considering potential treatments for diseases with severe
unmet need.74 Likewise, the EMA gives special consideration to areas of unmet need. The DCVax-L trial was originally designed and powered for mPFS as primary and mOS as secondary outcomes. It’s not unreasonable to expect regulatory agencies to allow use of mOS in place of mPFS, as survival is the goldstandard and most important outcome. This is particularly likely considering that the FDA approved Bevacizumab for newly diagnosed GBM, which failed for both mOS (primary) and mPFS (secondary) in the Gilbert et al study and also failed for mOS (co-primary) in the Chinot et al study. While Chinot’s study suggests there is a mPFS (co-primary) benefit, the toxicity was also increased. While decisionmaking will rely on standards and the preponderance of evidence, regulatory leniency will not be surprising in the context of GBM, a deadly disease with severe unmet need.

I'm like you - I hate it when patients don't follow the script ....
AND THEY SHOULD PAY THE PRICE

Finally -

ssssh - betweeen us only - TOP SECRET KINDA STUFF - okay?

Did you see that 26% of THESE trial patients WERE previous
Checkpoint Inhibitor patients?

Whats that about?

and where are the rest of the CI's with that indication?

Did the CI's "handle them" -- if you catch my drift.

Thanks for keeping me abreast of modern medicine.

regards

[abeta]

ic - I forgot to ask -

What -- WAS -- the OS on that trial?

On second thought - never mind -

the PFS was higher then whats its name - they should close the books
on this puppy - right now.

Saves time - saves money.

regards

[abeta]

ICLight ..... SHAREHOLDER ALERT:

SHAREHOLDER ALERT: Bronstein, Gewirtz & Grossman, LLC Announces Investigation of AVEO Pharmaceuticals, Inc. (AVEO)

The investigation concerns whether Aveo and certain of its officers and/or directors have violated federal securities laws.

On January 31, 2019, Boston Business Journal reported that “Aveo revealed that it won't submit its application for FDA approval due to a recommendation from the agency gather more late-stage testing results. Specifically, the FDA is asking for additional survival data, echoing concerns that led to the agency's rejection of the same drug in 2013.” Following this news, Aveo stock dropped 57% to just $0.76 per share during intraday trading on January 31, 2019.

https://finance.yahoo.com/news/shareholder-alert-bronstein-gewirtz-grossman-180406676.html