NorthWest Biotherapeutics Inc (NWBO)

[sentiment_stocks]

Hi DONOEVIL...

Just a quick reminder (prompted by abeta on YMB)...

bear trap spoke with Dr. Bosch as well at SITC a week or so ago. I thought I'd repost that portion of the post where he discussed PFS and OS. I think I'll go with his take that the FDA is VERY happy with the design.

Dr. Bosch says the FDA is very happy with the fact that L is designed to look at both endpoints- PFS and OS. NWBO has designed the trial around both endpoints and both will be considered by the FDA when deciding on approval or not. The importance about including PFS is that the trial can finish earlier, (but we all know that it's gone on long enough that we should get plenty of data on OS, as well.) Dr. Bosch said there was no need for NWBO to change endpoints after the IMUC failure because of how their trial was set up to include both.

Dr. Bosch also told me that when the trial was redesigned last year it had to do solely with the fact that they recognized that some patients would go into the trial with a suppressed immune system, due mostly to radiation therapy. These patients probably cannot be helped by DCVax L and that would bring down results. (This, I gathered, was above and beyond the white blood count limitation for the trial.) He said they did statistical tests and determined they needed to expand the trial and change the months to account for these patients who's immune systems were compromised. in fact, what he said was exactly what the PR originally said. (The change had nothing to do with fast tract/AA)

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