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all charities use this crap to raise money
ah so AF was guilty, what was the outcome of the trial
then was does the SAP contradict that ??????? show us a definitive FDA statement
LOL who is that saying a long line, who is in that line ???
yes some patients would want to try it, but one of the issues they acknowledged in the trial was slow recruitment, so WHY, was there not an onslaught of study participants
second I suggest reviewing previous ODAC meetings, Period
no it isnt a breakthrough, we are not even sure at this point it is even approvable
why trust what is in a company website??? sheeze
so, show us the full safety data base and maybe we would come to the same conclusion .
doubtful, the so called safety record has not been fully scrutinized as yet, but be that as it may, the FDA is unlikely to approve if there are concerns over the decisions made in the conduct of the study that may amount to putting the proverbial thumb on the scale. The FDA is not motived by the pps and potential riches for investors
try repeating the study but without the "mistakes"
LOL I am not persuaded.
sure it does. one of the major objections to approval will be the crossover and interpretation of results. Confounded is often used. It is pretty clever to argue that the crossover was mandated, making it more difficult (but not impossible ) for FDA to reject. However, I see no proof that FDA actually did mandate same
no actually I am simply repeating what the statisticians are saying. no one can refute it
thanks. notice NO mention of the FDA
so no actual proof, ok
prove it, and while at it explain why the SAP says otherwise
LOL I am devastated, but just a reminder, they are not my words, they are the words of the independent stat firm
Phase III Clinical Trial Evaluating DCVax®-L,
Autologous Dendritic Cells (DC) Pulsed with Tumor Lysate Antigen,
for the Treatment of Glioblastoma Multiforme (GBM)
Northwest Biotherapeutics
Study ID: 020221
STATISTICAL ANALYSIS PLAN
Prepared By:
Quantics Biostatistics
Ann Yellowlees, Director
Daniel James, Principal Statistician
LOL LOL
too bad that I have the actual truth from the SAP
here is what they said:
A crossover option was included in the Trial design on demand of patients and investigators, and was
necessary to enable recruitment and retention of patients when the Trial began 13 years ago in
2007.
whats missing FDA LOL LOL, this could cause real problems with the FDA
I was asking for the actual investigators in the study no offense
could you ask those guys why the SAP makes no mention of any FDA mandate on the crossover??? Very curious
Oh ok so why does the sap contradict what ll said ?????
lol total nonsense but thanks lol
LOL yeah do that LOL LOL
already did, read my posts
nonsense, no one knows if this is superior to SOC.and of course that has nothing to do with what appears to be a misstatement by LL
I want to believe that, but show us proof
i did lets give here the benefit of doubt, she probably just made a mistake in the interview. she is human afteralll
why did the SAP say otherwise?????
oh, ok show us the proof
I think someone should ask LL if she would like to change her statement
of course that was NOT in the article
no it isnt far from it
of course that has NOTHING to do with what I was discussing
in the interview she gave today I am pretty sure she said this was required by the FDA . I think what is in the SAP is a more accurate discussion of this issue
note sure what to make of this from the SAP
that is NOT the same as validating the results. Happy to explain if needed
LOL round the world, a great exaggeration
I dont know anything about that but I find it interesting that shorts moved the price today. I always thought they dropped the price