Replies to post #315379 on NorthWest Biotherapeutics Inc (NWBO)

[marzan]

wow sharpie sharp finding indeed, how comes we missed it. rGBM is a bonus and interesting. One stone 2 birds!

[sukus]

500,000 cases a year on recurring. How can we make a dent on this folks? Too many demands.

[VuBru]

If they made a similar proposal to the FDA, that is a game changer in terms of likelihood of their being able to report meeting their primary (revised) endpoint in upcoming TLD. This endpoint is met even based on the blinded data.

[ATLnsider]

I agree. I think the endpoints may have been changed because of the revised SAP. If the EU clinical trial register is looking at recurrent GBM, it is possible all 4 RAs are doing the same.

If I remember correctly, all of the 4 regulatory agencies (USA, UK, Germany & Canada) were submitted the same revised SAP. I believe NWBO got buyin from all 4 RAs.

This could be a mic drop moment...

[sentiment_stocks]

Recurrent GBM is an even larger market.

Amazing!

[beartrap12]

Sharpie, you’ve absolutely nailed it! NWBO is going for recurrent GBM within this nGBM trial! This is based on the secondary endpoint.
I suggested years ago that the company would have enough info between this trial and the Expanded access protocol, which has its own clinical trial, to go after rGBM, but my idea got knocked down by posters because it wasn’t in the trial to go after rGBM. Well, now it is!
I suspect this is why Linda created a separate clinical trial for those who had failed to make it into the main trial. These are the patients who progressed before they could get on DCVaxL, which takes about 3 months after surgery, and those who were possibly so quick to respond to the vaccine that they looked like early progressors, but were possibly actually pseudoprogressors.
This opens up a huge new area of treatment and profit if this endpoint is approved by any of the 4 regulators.
Yes, the confirmed PFS are the adjudicated cases.
The third secondary appears to be the original PFS endpoint. It’s actually good to see that still assessed.

[Looking4aprofit]

This could be the second home run she hinted at!