Replies to post #44463 on NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

And what you are leaving out is that the total enrollment for both of DNDN's 2 trials was less than 348. --notbrad

Sorry, what?! The first P3 randomized 127 patients and the second (IMPACT) randomized 512. That's 639 patients buddy.

There was also a large P2 that randomized 98 patients. However those data didn't look so good:

14.3
Study D9902A
Study D9902A was a random
ized, double blind, placebo-
controlled, multicenter trial in patients
with asymptomatic metastatic castrate resistan
t prostate cancer. A total of 98 patients were
randomized 2:1 to receive PROVENGE
®
(active treatment, n=65) or
placebo (control, n=33).
Study D9902A was identical in design to Study D9901.
Baseline demographics and disease characteris
tics were generally well balanced between the
treatment groups. Several prognosti
c factors, including the percen
tage of patients with more
than 10 bone metastases, and median values fo
r PSA, LDH and alkaline
phosphatase favored the
placebo arm. Of the 33 patients randomized
to placebo, 22 patients (66.7%) crossed over to
receive antigen loaded (PAP-GM-CSF) APCs pr
epared from autologous APC precursors that
had been cryopreserved at the time of placebo ge
neration as part of the salvage study. Following
disease progression, 38.6% of patients in the PROVENGE
®
arm and 34.4% of patients in the
placebo arm received subsequent
treatment with docetaxel.
There was no significant delay in time to
disease progression (HR = 0.921 [95% CI: 0.588,
1.443];
P
= 0.719, log rank) and no significant difference in
overall survival for patients treated
with PROVENGE
®
compared to placebo (HR = 0.786 [95% CI: 0.484, 1.278];
P
= 0.331, log
rank).

They also conducted lots of other studies with over 100 patients before they went belly up like these:

https://clinicaltrials.gov/ct2/show/NCT00005947?term=Sipuleucel-T&rank=29

https://clinicaltrials.gov/ct2/show/NCT00779402?term=Sipuleucel-T&rank=25

https://clinicaltrials.gov/ct2/show/NCT00715078?term=Sipuleucel-T&rank=19

so by my count we're already up to over 1,100 patients. And there are other studies I'm not counting here.

And it doesn't matter how much those plants initially cost, the $640mm went on the books as debt and made up MOST of your cited $1B+ loss.

And Provenge was much more expensive to make! Some say 3x what it costs to make DCVax-L.

Here next time you want to quote numbers check the FDA docs first, like this one:

http://www.fda.gov/downloads/BiologicsBloodVaccines/CellularGeneTherapyProducts/ApprovedProducts/UCM213957.pdf