Replies to post #470697 on NorthWest Biotherapeutics Inc (NWBO)

[scotty3371]

Thanks flipper.

[Kaizenman]

flipper44: Thanks for the perspective!

Peace.

[spidaman]

Great post as always flip. You da man!

[CrashOverride]

Bosch laughed when asked about injections into tumors. He said that's a whole other presentation.

I think we will have one that includes this topic, DCVax Direct, at ASCO.

[muee88]

Thank you very much, Flipper! I know I speak for everyone when I say that your presence and analysis are comforting on such a “wild ride” of a day.

[Basin Street Blues]

Thanks Flipper TO GET BACK ON TRACK LINDA P MUST :

1.Change the endpoints on the US clinicaltrial.gov site immediately

2.Get the journal out this weekend

3.Announce MHRA application has been made

She accepted the embargo and yet went ahead with the NYAS , but I assume she saw it as a way of lighting the blue touch paper , however hind site is an exact science and it was seriously misjudged.

[eagle8]

Thank you flipper.
Good to see you here again.

GLTU

[dmb2]

flipper44, as usual your take contains some astute points.

I agree on the surprise on the result against significant residual disease after NWBO disclosing tumor debulking was an important factor, but the difference between levels of resection can be dramatic and there is no quantification here. So this result is actually good news.

The 1 piece of data that is perplexing is the 20% survival at 3 yrs for the 232 treated population, which I expected to be higher, given the previously reported blended 28%. The missing population in the 20% is the original placebo group comprised of the 64 crossovers and the 35 non-crossovers. Of the 64 crossovers only 6 patients survived to 3 yrs, so only 10% of that group were included in the 28%. This leaves only the 35. Does this make sense to you? TIA

GLTA here, much to come and a review or two of the slides is highly recommended

[Fireman02360]

I think MHRA will move quickly now.

What is the turn-around time on something like this with the MHRA? Also, does NWBO have any fast-track or equivalent in the UK? Someone posted a old company 10k (2018?) to this some question I had from yesterday, that NWBO had a FT plan in place but has not received FT from the US FDA. I am assuming they applied for it? Why it was not granted? Also, If results are so good, NWBO should have zero problem getting fast-track now AND Breakthrough Designation, no? If the company doesn't apply for these two designations, they are doing us shareholders a disservice.

Thoughts?

-Fireman

[hoffmann6383]

thanks for sharing flipper

[xoma4578]

Thanks Flipper.

[Smokey21]

Welcome back Flipper. Always appreciate your perspective, and many others who have taken the time to share their views here. I haven’t sold a share, and don’t intend to until the true value is unleashed here. GLTA

[ATLnsider]

Thanks for sharing your impressions flipper44

[highwayman4life]

Thanks for your interpretation Flip!

It honestly amazes me that some (whether they actually took time to look at the slide deck or not) braggadociously clamor on about the trial being a failure. Apparently their vitriol knows no boundaries.

MHRA approval coming soon!

GLTA

[scotty3371]

Hey Flipper would data lock at 36 months have been a better data set?

[exwannabe]

On another note, the five year survival we heard about Tuesday is real survival — not extrapolated. In other words, they did not take a pool strewn across two to six years to arrive at five year survival, instead, they took patient data on all patients initially enrolled through five years. Over 13% survived. It appears all lost to follow up were found.

No, it shows 25 actually lived 5 years. That is only 10.8%. To get to 13% they estimated the survival of the LTFU's, many who had been on study only a year or so before being lost.

The next endpoint concerns OS against a placebo control. The final one is tumor response against a placebo control. Seeing the excellent p values and hazard ratios today on the primary and follow up endpoint, i’m assuming the next four endpoints might be better than some crtitics might assume. Just because they weren’t shared with topline results, does nit mean they are a foregone conclusion

How is the OS between the 232 and 99 be anything other than a complete failure when the blended population lived longer than the treatment arm?

The surprising (I was not expecting this) statistical significance against residual disease...

Think hard of the populations being compared and the inclusion criterion. Will explain in another post.

[H2R]

Graphs v. Numbers: Some Errors?

Looking at the numbers provided with the graphs, it seems the graphs look worse than the actual numbers. For instance, take Slide 29 numbers to get a % survival. Those percentage are shown on top of the original slide, with the location of differences on the graph.

It does not quite line up with the graph (esp. the external). It makes the external look better, hence the overall results look slightly worse.



Flipper: Thoughts?