Replies to post #710566 on NorthWest Biotherapeutics Inc (NWBO)

[Roman516]

HyGro, your facts are biased, and your numbers are way off base,
"There have been 8 publications that have documented to trial defects."
Should state, there have been 8 publications that have been paid to print and fabricate the truth by lying about trial defects.

However, there are over 300+ oncologists, cancer doctors, cancer research centers, and universities that support NWBO's effort to move forward for approvals. So, there is a 300+ to 8 ratio that support NWBO.

It is only your opinion that "NWBO has violated FDA guidelines for oncology comparators"

In fact, there is zero basis that NWBO has violated FDA guidelines for oncology comparators, IMPO.
Plain and simple, your attempts to fool this board fail time and time again, IMPO.

[Doc logic]

HyGro,

“Should” per FDA does not mean “must” and the peer review group at JAMA Oncology agree with how “should” was dealt with which is also how FDA looks at each case presented to them to make a determination of “adequate” as in “adequate and well controlled studies”. Go fish!; ). Best wishes.

[meirluc]

Please HyGro - not only was NWBO not guilty of violating FDA guidelines
for oncology comparators, it was the FDA itself that was complicit in
changing the original trial guidelines by mandating that all the patients
that have progressed, be given the opportunity to be treated with DCVax-L.

Since about 2/3 of the progressors crossed over, the trial lost its control
arm and had to resort to ECAs as comparators. We can therefore blame
the FDA for changing its own guidelines.

Thank you FDA for changing your own guidelines. Without your initiative
we would never have known DCVax's stunning efficacy for rGBM patients.