Replies to post #798126 on NorthWest Biotherapeutics Inc (NWBO)

[AllSheWrote]

Some sort of approval is likely in the next 4-6 months, but there may be conditions attached considering how long this has dragged on.

There is no basis for the assumption that approval is likely in the next 4-6 months. In fact, because of how long this has dragged on it is far more likely the opposite is true. The company submitted scientifically invalid trial results to the MHRA. The company knows this, and it's the reason they chose not to submit the results to the FDA. That's why there is no news after almost two years since submission. It's over. And whether the MHRA has explicitly denied the application or not, they have made it perfectly clear to the company that the application is not getting approved as-is and will require major re-working of the data to fix the flaws. My guess is they have kindly suggested the company either submit the patient-level data from the study's own control group, or start over with a new trial. The company has not responded to this conundrum, because they know either option is a death sentence. Nor have they informed shareholders, because informing shareholders is not their style. They are going to ride this out and keep paying themselves as long as they can.

[seekinganswers]

The only possible approval would be to allow a confirmatory phase 3 trial, at best.