NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I'm no expert, but other here previously posted the FDA guidance on use of off label drugs. Once a drug is approved the regulators are reasonably open to its use. In more than one case patients have taken their insurance companies to court to gain access to drugs off label that have anecdotal evidence that demonstrate their benefits. I believe the insurance companies have lost so frequently that if a Doctor deemed to be a subject matter expert wants to use the drug they practically always grant approval, though they may challenge the Drs. choice and take awhile to approve it.

In my treatment at City of Hope the insurance questioned certain drugs my Dr. wanted, but it never took more than a week to get the drug they wanted me to have. Many of the drugs being used by oncologists, etc. don't have specific approval for the disease they're being used for, yet they've become a part of the SOC for that disease.

Gary