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dennisdave

07/25/24 11:14 AM

#708177 RE: FeMike #708171

I do agree that the company would be fine

NWBO will not be fine if the MHRA rejects the request for approval as long as NWBO finances Advent. If in that case, they will have to cut off Advent and fire 50% of staff at NWBO HQ. But what would they then be left with? They could in that case not even finance a trip to Disney land to celebrate their wonderful achievements let alone any new medical trial.
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DrHigh

07/25/24 11:16 AM

#708178 RE: FeMike #708171

my guess is LP has a contingency plan to ensure the IP end's up in the "right hands"
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learningcurve2020

07/25/24 11:20 AM

#708181 RE: FeMike #708171

100%. In a bankruptcy and with no real shareholder advocacy, the IP will be picked apart. Advent could easily pick up the pieces.
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dstock07734

07/25/24 11:20 AM

#708182 RE: FeMike #708171

How could MAA be rejected? This is no such possibility.

Do you have common sense? By now over one thousand of patients all over the world must have received the DCVax-L treatment paying out of their own pockets through compassionate use program. Each case has to be reviewed individually by MHRA. How is it possible that MHRA would not grant approval?

See the NCI data on biomarker measurements from 29 patients from the p3 trial. These data were measured before the DCVax-L treatment. If the data after the treatment is added, I can spot right away which mutated genes are highly overexpressed on cancer cells and can be loaded on ADCs. Nothing complicated here. It is very simple.

As for the approval, given how closely MHRA and FDA have been interacting over the past several years, it strikes me MHRA is waiting for the readiness on the US part. But this is my conjecture.