Replies to post #730041 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

I have always said that the absence of individual patient-level data is a huge problem for the FDA, heck the American Brain Tumor Association raised the same problem.

https://www.raps.org/News-and-Articles/News-Articles/2023/5/Stakeholders-want-more-clarity-from-FDA-on-using-d

An FDA proposal to require the inclusion of patient-level data in marketing applications may prevent the use of external controls for some rare diseases, the American Brain Tumor Association said in their comment. “[I]ndividual patient-level data (IPD) is not always available for many cancers and other rare diseases,” they wrote. “This is due to many barriers that interfere with data sharing in healthc

[Steady_T]

That might make sense for a well funded company. Alas, Northwest is not a well funded company.

If they filed with the FDA and the FDA requested an additional trail it would put Northwest in possibly a terminal situation.

Much better to reduce the risk as much as possible by going to the UK where the regulators already have a lot of experience with DCvax-l. The production facilities are located in the UK, and those facilities have already been inspected and certified.

Then there is the production capacity issue. It is quite likely that a US approval would swamp the production facilities.

Other than that, your point is OK.