Replies to post #36348 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

See, I knew you could directly address me without going through an intermediary -- kind of.

1. What was the life expectancy of these patients?

2. What was the diagnosed rate of progression for these patients?

3. When did the trial life expectancy protocol change and how many A's and B's were under each protocol?

4. What is the mix of A's and B's still alive and which method was used for the longest survivors?

ReadyforBluesky

My answers:

1. We do not have patient to patient profile. That granularity is not typically given in stage I. However, I suggest that you start looking at previously treated inoperable 4th stage cancer statistics. This means they are surviving beyond treatment failure. For instance, 86% of patients on method B are alive at approximately 9 to 16 months.

Take the example of non small cell lung cancer. The median survivals in all histiological subtypes is 4 to 6 months. Review Figure 1 in the following link. Remember Koman, these statistics are not after prior treatment failure.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3096514/

2. Diagnosed rate of progression is not given, and it is not typically given in a stage I trial until final results are published, but we currently know:

All patients had stage 4, locally advanced or metastatic disease
• Patients had an average of 3 tumor lesions
• Patients had a median of 3.1 prior therapies

Consider, stage IV patients that had already failed 3 prior therapies on average.

3. It appears to me from reviewing clinical trials.gov protocol and MDAnderson protocol that the life expectancy protocol did not change until after phase I enrollment was complete. Note: only 3 patients died in method B, and 2 of those died within approximately 2 months from the time they started therapy. So those two patients clearly had an actual life expectancy of 3 months from the time of enrollment and 2.1 months or less from the time they received their first injection.

I now you want granularity, but again, consider these stage IV inoperable patients already failed at least one prior treatment.

Also consider Method A, where 50% of patients died. Those that passed away did so at a median of less than 4 months. Again, this is another indication of how sick the patient population were.

4. The mix of A and B patients still alive is: 9 Method A, 18 method B. The method used for the longest survivors is not given, but look at the chart. There is no infiltration of red and yellow lines into the green. So, all surviving patients thus far are at 9 months +. Thus consider the statistic. Combining method A and B, 90.5% that obtained stable disease at week 8 are still alive. Dr. Bosch is stating those patients have extended survival.

Basically, if you look at another simple fact from the chart. 100% of patients that live past 8.5 months are still alive. Again, no red and yellow lines encroach into the green. Even 5 patients did not yet have stable disease at 8 weeks are still alive, yet those patients survived beyond 8.5 months, and they are still alive -- as of May 30, 2015.

You'd have to really think MDA and Dr. Bosch are trying to pull a fast one on everybody to deny the encouraging aspects of this trial.

Still, it is phase I, and as many of us try to point out time and time again, it was a very conservative treatment protocol. The phase II trials will not be constrained by the prior safety concerns, and I'll just put the following out for you as a marker. I anticipate the phase II efficacy results will be better and more rapid than phase I.