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exwannabe

06/19/17 9:10 PM

#122798 RE: Evaluate #122794

Evaluate, "blended".

This term means the entire population, w/o knowing which arm they are on. The two arms "blended" together.

It came into being because saying "blinded data" is weirdly ambiguous. Does it mean the data still blinded, or the access to the data unblinded.

Thus "blended". It is a common term used in this context.

flipper44

06/19/17 9:11 PM

#122800 RE: Evaluate #122794

Hey Evaluate.....Have a nice day.

ou71764

06/19/17 11:30 PM

#122818 RE: Evaluate #122794

Evaluate,

IMO you are correct that the favorable blended numbers don't guarantee a successful trial.

If SOC is 12 months and blended results are 20 months, you still need to know the breakdown of the blended results - who was on the treatment and who was on the placebo, and how well did each group do?

I know some people are thinking something along the lines of "if SOC is 12 months, and the blended results are 20 months, then the treatment HAS to have had results greater than 20 months. That's a mathematical certainty - so the trial is a lock to be a huge success."

And that is a correct line of reasoning, if indeed the control group does match the historic norms for SOC. And it may be true for NWBO - I hope so. But people who have invested in small biotechs before probably have been burned by the following: that the control group often exceeds the historic norms.

At this point, IMO the news of the granting of options is far more bullish than any analysis on the pace of enrollment and timing of events.

H2R

06/20/17 2:53 AM

#122829 RE: Evaluate #122794

Hi Eval,

From different articles and presentations I've read/seen, I would tend to place a historical mPFS around 8 to 10 months. Maybe for some strange reason in this trial it will end up being different, but I would put an 75% chance or more for the placebo group to be close to that range. It would be unlikely IHMO to have the mPFS above, say 12 months. The mPFS will not be confounded by the crossover. So with a placebo mPFS at 12 months (very conservative) assumption (and that's all it is, an assumption), "If mPFS blended for the DCVax-L trial is somewhere between 16.0 to 20 months, " I would see the chances of success to be over 95% on the primary endpoint.

Best.

Good luck to Patients, NWBO, and Longs