NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Tricky Koman.



You drew fat-cat in with a vague statement that might be positive, then lowered the basher boom on him. Slick.

Your logic is suspect. You said:

Prolonged interim analysis to me is not a good sign. If the data was extremely good based on 66events, it would be halted or simply continued to the next event. If there is some potential for separation of efficacy then it will be continued to see if the separation continues. BUT if there is no difference, they may wait for further events for confirmation before advising halt to the trial. Also, I'm having doubts that NWBO will meet their target date for completion of enrollment for pIII GBM trial and expect them to delay again the anticipated completion date (another bad sign).

-- Koman


First, let's take your premise that "if the data was extremely good, it would be halted or simply continued." I agree if the data is good, a continue does not usually take long.

But, you can't in the same breath use this to say a halt would happen quickly if the data was very good. The latter is simply not usually true, especially in a disease that is fatal. Do you know what happens when there is a recommendation for a halt for efficacy before the public is informed? The DMC gives the data to the sponsor to review to see if the data met all the endpoints. The sponsor goes over every data point with a fine tooth comb, but they do not know the identity of patients receiving placebo or therapy. In the case where the sponsor concludes that they will accept the DMC recommendation to stop for efficacy, they must securely contact every clinic (which is now over 56) and make certain every patient is able to be immediately reached and informed regarding what will happen to them if and when the trial is halted. The FDA is often brought in by the company to meet with the DMC and sponsor for any legitimate insights. The sponsor themselves can actually reject a recommendation for halt due to efficacy by the DMC because they believe obtaining data on the secondary and tertiary endpoints is too important, and they might want to see 22 more events in order to see if the powering for conclusive treatment in those subgroups will also be appropriate if the drug is approved. In that case, the halt for efficacy is rejected by the sponsor, and the DMC continues their job.

If the drug is not yet showing separation from the placebo group, and no safety issues appear, then they simply continue the trial because only 60% of the final 100% of data is in. They do not, as you are suggesting, "wait" 2-4 more weeks to see what events may add to their data, they instead would "continue" to the 88th event.

Let's take your next point. Enrollment. NWBO was counting on German clinics to add to their enrollment rate some time ago, but the Germans made NWBO jump over many additional technical hurdles, because Germany is like that. Finally, NWBO received approval by the German Government, and NWBO is just finishing up training and infrastructure to open their clinics.

Finally, The response rate for PD-1 PD-1l therapeutics is very low.

I know, if you throw up enough material, you hope something will stick in some investor's psyche.