Replies to post #217787 on NorthWest Biotherapeutics Inc (NWBO)

[kabunushi]

Millions of the warrants expire this year. We're not going to end up with a billion shares outstanding without also seeing funding in the bank for another couple of years easily. Because the only way we get full dilution is if all those warrants get exercised, which will also yield us well over $100M cash.

If the forces of FUD could manage to keep the pps down below .30 then maybe a lot of the warrants would expire worthless, hence the current feared 1B share count evaporates, though of course we would be exposed to more large scale dilution again. But if those 1B shares do materialize then as the necessary corollary we will have a large war chest, much more than we have now. We might get caught in a negative cycle where the stock is low and that causes more and more dilution; however to get there, much of the last dilution will also have to go up in a puff.

That basic dilutionary calculus is something which I think Umibe san is failing to give enough credit to. It's been very easy to be gloomy while watching rallies get cut off at the knees via endless supply of shares at .30 over the past year. But it looks like there is a chance that supply has finally dried up, and higher prices just might continue and indeed turn around and beget still higher prices, knock on wood!

[sentiment_stocks]

I’d like to present a more positive case for PFS then umibibe’s.

In Feb 2017, the company announced they’d reached 248 PFS events. Now you know those events had not even been adjudicated as I believe it was about this time that they knew they were going to have to reevaluate them, as was noted they will be doing on LL’s slide in November 2018.

Now think about that. Everyone had been enrolled in the trial by February 2017 for at least 15 months, and 83 of them had not even evented. I think it’s also important to note that in LL’s December 2016 SSF presentation, she stated that of the 25 “indeterminate” information arm group, around 10 of them had also not evented - and that group dates back to 2011/2012! That’s about 40% from the information arm that had not even evented for 5 to 6 years! Still.. I’d argue that those 10 patients were first “reevaluated” since they were put into the information arm in the first place for having evented according to the what was fast becoming antiquated criteria for an immunotherapy trial. Second, those ten were likely psPD patients due either to chemo/rad or DCVax-L, or both.

But please note that those 83 still alive main arm patients who had not evented by February 2017 were also NOT reevaluated. So they had reached this point based on the unrevised criteria in the trial.

That represents 25% of the 331 total trial patients who were alive and had not PFS evented by 15 months. We don’t know how the remaining 248 patients had performed with regards to the PFS endpoint, but I think it’s safe to assume that there were surely some number of them who had performed similarly.

In the 1st accidentally leaked protocol, the PFS median (which is not the endpoint, but it gives guidance on performance) for the treatment group was assumed to reach 13.5, and 7 for the control group. In the second accidentally leaked protocol, the PFS median for the treatment group had been dropped to 11 months, while control remained at 7. This was due to the changes made to the trial that were made public in August 2014, looking for only a 4 month difference between the two arms.

So the mPFS for treatment was predicted to be 11 months. And in February 2017, there were 83 patients alive and above 15 months mPFS. If we assume that the majority, or even all of the 83 were treatment - because control patients would not have had the benefit of receiving DCVax-L until after they PFS event - that would be only 33 less than the mid point for the entire 232 treatment group with a mPFS over 15 months.

So…
83 15 months alive, with NO PFS events yet, assuming all treatment
116 middle treatment patient - PFS event time unknown - will determine mPFS number
232 total treatment patients

As mentioned, 83 patients having not evented represents 25% of the entire trial population. This is also NOT a KM based assumption, but the actual facts.

So where might those additional 33 treatment patients come from to reach over 116 patients with a mPFS over 15 months (not 11)? If we assume those 83 patients were treatment, and subtract them from 232, that leaves us with 149 remaining treatment patients. Apply 25% to that group, and that is 37 more patients who would not have PFS evented by 15 months.
83 + 37 = 120 patients.

If these assumptions are correct (that all 83 were treatment; and applying 25% to calculate how the remaining 149 treatment would have performed), then that would mean there were 120 possible treatment patients of 232 treatment patients, which is 51% of treatment who would reach 15 months PFS event free.

In other words, the mPFS on the non-adjudicated, non-reevaluated data could be around 15 months for the treatment group, and the protocol called for 11 months for this group.

Now for sure, there are assumptions built into those numbers. But even without a “reevaluation”, one can see that if the treatment arm shows a mPFS of around 15 months, then the chances for success on the PFS endpoint look pretty promising, because 11 is what they hypothesized they would reach.

The thing about the PFS endpoint is that the control group did not receive the treatment. So you really are comparing apples to apples here, with the difference being DCVax-L.

Additionally, those 83 alive patients with no PFS eventing after AT LEAST 15 months argue that the PFS KM curve will exhibit a long tail. That long tail should help translate the curve into presenting a successful hazard ratio.

So despite the fact that they are reevaluating PFS based on the new progression criteria, the old criteria looks like it may have achieved a single homer on its own.

And with the adjudication of those PFS determinations, those numbers look pretty solid, if not set to improve.