NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

For off-label use…The 21st Century Cures Act… will take on more importance as well, once they are approved for gbm. I think a lot of people here do not realize the significance of that bill, not just now and before approval, but especially after approval. It’s a big deal. The use of Real World Evidence and data summaries combined with the existing, simple requirements for combination therapies to become the standard are quite encouraging overall.

Under the law, the process to add new indications for an already approved drug and to get insurance coverage is much streamlined and allows for use of real world evidence, data summaries, insurance claims data, patient input, and anecdotal data rather than a full clinical trial.

“Among other measures, the legislation calls for the use of “data summaries” to support the approval of certain drugs for new indications, rather than full clinical trial data. The Cures Act will also allow drug companies to promote off-label uses to insurance companies, allowing them to expand their markets.”

https://www.statnews.com/2016/12/05/21st-century-cures-act-winners-losers/

Re combinations, very encouraging and straightforward:

https://www.cancer.gov/about-cancer/treatment/drugs/off-label

NWBO is setting this thing up to fly by focusing on manufacturing and Flaskworks, they will be well positioned to hit the ground really running at incredible speed in my opinion.

Combining with drugs already approved for another indication also could really expedite things.

Anyone with the opportunity that does not partner, is nuts. Of course all IMHO.