NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

doingmybest,

This is the canundrum:

1. PFS was the right endpoint for
seeking AA.
2. Because PFS was the primary,
FDA decided a crossover should
be required which would
confound the secondary
endpoint.
3. Secondary endpoints can be the
basis for approval in diseases
with limited options.
4. Will FDA take ALL evidence
into account including
analysis of post
crossover treatments and
use all available methods
to properly interpret the
data? Subject to sentiment.
5. The Phase 1/2 dosing regimen
was less agressive than
Phase 3 and the Dr. Prins
comments were not
directed at Phase 3 data.
6. Dr. Linda Liau's comment that
all patients appear to be
living longer was directed at
Phase 3 data.
7. Dr. Linda Liau's comment that
the required number of events
had not yet occurred also was
with regard to DCVax-L Phase 3
8. A rolling submission process
is possible based on Dr. Prins
comment about the Phase 3
trial still accruing patients
and recent suggestions about
manufacturing equivalency.
There may be a petition for a
patient rebalancing option
if needed or spot for
pseudo progressors to join the
main cohort which leaves the
new screening on hold pending
data review or other issues.