Replies to post #805400 on NorthWest Biotherapeutics Inc (NWBO)

[Investor082]

Correct. They are planning compassionate use in the US rather than regulatory filing/approval in the US. Also, they are spending money to pivot towards Direct and in licensed Roswell tech rather than L application in the US. Tells you everything you need to know.

Either way, no serious company would wait 5+ years since data lock to file in the biggest and most lucrative market. It’s crystal clear - they know FDA will reject so they continue to kick the can! Shorts have been correct about US FDA all along.

[attilathehunt]

...highly unlikely they will file to FDA in 26 in my opinion.

My guess is LP will use RWE on the compassionate Direct trials to file with the FDA and forgo L due to costs...

[cptbac]

If they don’t submit to the FDA in 2026, and soon, I would fully anticipate, & expect a change in control. Given their age and commitment I cannot see them starting something so big and not finishing it. Continuity is important. Frankly, I think that ship has already sailed for this team. Sold, partnership, or consortium is what it will be. I would be disappointed if they didn’t enjoy their golden years. What it is. We will all get there someday.