Replies to post #671130 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

It was called hospital exemption, and it turned out to be very very difficult to utilize, because you had to negotiate reimbursement with each German district. Also, the German regulator appeared to want automatic closed system manufacturing.

The compassionate program worked well in Great Britain however.

[biosectinvestor]

The Hospital Exemption program has turned out to just not be a practical program. It was not just in Germany that such programs existed but they've gotten virtually no traction because the programs were set-up poorly and really don't help small companies with new drugs and even big companies don't seem to like the programs all that much. Some of these compassionate use programs, other than the UK Specials program, which is more practical, seemed to really only work for PR. Not that the regulators set them up with that in mind. But the regulators appeared not to set them up with a mind to actually whether the programs would be sustainable or not. Turned out, because of the rules that they put in place with these programs, they simply could not be sustained.