Replies to post #135408 on NorthWest Biotherapeutics Inc (NWBO)

[XenaLives]

Nah, I was just studying up on the changes and the regs recently. Knew it would be there somewhere.

With the new regs favoring AI analysis, I think it's more likely that they are getting some consulting in this area.

[Extremist223]

Anders not only that, but as exwannabe said as well.


Hum Vaccin Immunother. 2014 Nov; 10(11): 3139–3145.
Published online 2014 Nov 1. doi: 10.4161/hv.29276
PMCID: PMC4514134
DCVax®-L—Developed by Northwest Biotherapeutics
Stavros Polyzoidis1,* and Keyoumars Ashkan1

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4514134/

Furthermore both in the U.S.A. and in Europe DCVax®-L has been granted orphan drug status for GBM and other gliomas. As a result DCVax®-L will have market exclusivity for 7 years in the U.S.A.

EDIT: This is OLD, may not be current.

https://www.fda.gov/downloads/drugs/developmentapprovalprocess/smallbusinessassistance/ucm276029.pdf

Slide 15

U.S. Orphan U.S. Orphan-Drug Designation Drug Designation
Incentives Incentives

7-year marketing exclusivity to the first sponsor
obtaining FDA approval of a designated drug
- Tax credit equal to 50% of clinical investigation expenses
- Exemption/Waiver of application (filing) fees (PDUFA)
- Assistance in drug development process
-Orphan Products Grant funding