Replies to post #729242 on NorthWest Biotherapeutics Inc (NWBO)

[learningcurve2020]

I order a personalized skin cream from Denmark that helps with my wrinkles.  I'm sure th the FDA considers a personalized experimental living dendritic cell culture that retrains the immune system to be the same. Eye rolls. 

[exwannabe]

I guess you missed the part that says can not be imported to then be sold for commercial purposes. The reg says nothing about purchase being forbidden for personal use rather it specified that it must be for personal use only and nothing about it needing to be free for use only that it can’t be resold.

The FDA regs are very clear that the drug cannot be being sold to US residents.

There is no known commercialization or promotion of the product to persons residing in the U.S.

In case yo do not understand the term, "commercialization" includes selling. So again, unless NWBO plans to give it away for free, it wold be illegal.

Do you guys really think that all anybody needs to do to avoid the need for FDA approval is to set up an ex-US operation? Seriously?

Time to give up this inanity.