Replies to post #159211 on NorthWest Biotherapeutics Inc (NWBO)

[photonic5]

You’re right. Now imagine that OS eventing has slowed to 1 per month by now. This trial could go on for a LONG time. But LL said it best on Feb 6, 2017...the longer this trial goes, the better patients are doing.

I still believe her.

[flipper44]

There is plenty of power to end the trial in my opinion.

(AVII took conservative PFS/OS estimates then applied those instead to conclude trial would be under powered in those set of circumstances. There are lies, damn lies and statistics.)

[StockFollower]

Thanks CherryTree1 - Awesome analysis!!

[blue_skies]

Thank you for the lengthy analysis.
If this is such a slam dunk then why is the stock trading at 30 pennies?

[Tadasana]

Thanks cherrytree, nice analysis.

[survivor1x]

I agree with your premise whole heartedly. It has been argued that the 331 may not be representative of soc population as whole. Removing either ends (longer and shorter lived) because of pseudo progessors being removed. I just want to make sure you are using the right %s. Also I came up with 9 maybe 10 per month in the last 12 months enrolled, 3 the last month, small difference. Do you have another more similar population to use for survival %s, like ict 107 control or others that accounts for removed psuedos? NWBO has more than the 331 to look at, although some are blinded(331) and some are not, they know the start and end dates of each individual patient. AVII's stats also assumes hazard event rates that are proportional without delayed separation and this underpowers his results, doesnt account for long/fat/flat tail. A soft landing if you will. In example if a placebo and treatment arm both had an mos of 18 months yet separation occured after and twice as many people were alive at 3 years in the treatment arm than this would be meaningful to patients. Stopping a trial early wouldn't capture this. Could it be they are looking at capturing landmark survival %s. If you almost double your chance of living at 2 and 3 years, I beleive this magnitude of difference would be stat sig and very simple to explain to the FDA, doctors, patients, investors, the st. Also the benefit in survival %s would presumably increase at 4, 5 and 6 years(more essentially "cured" pts). But we will never make it that far for all 331. They did say a slowing event rate.

[eagle8]

Thank you for sharing, CherryTree1.


GLTU

[BioInfo]

Only thing that bothers me (I am super long) is that patients are being deprived of this novel therapy by few BP interest groups and their Cronies. Its plain sad! IF this trial was of any BP, it would have already been approved, thanks for our FDA system and its corrupted ways on looking at smaller companies and protecting interests of BP

[Barunuuk]

Yes, this is similar to the calculation I did in my seeking alpha article several months back. However I focused on PFS which showed even more convincing results.

The only comment I have is on your discussion of NWBO waiting longer. In your examples the p value doesn't change the longer you wait, however, the difference in your examples and the P3 trial is that the p value will not be calculated on SOC data, it will be calculated comparing the 331 patients, meaning the SOC data will be the 110 placebo patients vs ~221 vaccinated patients. You recalculate the p value using your assumed results and 110 SOC patients, and the p value falls down dramatically.

Moreover, because it is a cross over, if DCVax-L actually does work, then the 110 patients will perform better than SOC, meaning that will drop the p value even further, SO, it goes without saying (if you are well versed in Statistics), that in this case, the longer the data is matured, the more chance the p-value will drop, meaning the fatter and longer the tail of the 221 patients compared to the 110 patients, the smaller the p value will be.

Hence, why Linda and NWBO is pushing this as long as possible.

I my mind, I have no doubt the PFS endpoint has been met, and is statistically significant, however the OS endpoint may not be as strong statistically if the patients that crossed over are living longer as well.