Replies to post #535921 on NorthWest Biotherapeutics Inc (NWBO)

[theorysuit]

I don't know where people get this idea that we suddenly will be valued/approved for all other solid cancers without trials. That's not going to happen. Applicable to other cancers, yes maybe but it still requires trials. And that takes time.

[vator]

Ok. A study never happened on Hospice cancer patients. On multiple types of solid cancers. I must have been in a dream state.

Silly me.

[biosectinvestor]

He did not say Top Line Data for other cancers. Those were your words.

There is data for other cancers. You do understand that also, others were discussing the new regulations and you changed the subject.

For an APPROVED drug, companies can work with the insurance companies to get coverage for off-label coverage based solely on real world data, which is not clinical trial data, but things like hospital records and economic data as well. The company does potentially have and likely will continue to develop data for such patients. Real World Data is not a clinical trial.

Likewise, for the expansion of a label, going forward, real world data can be used with the FDA and other regulators. The 21st Century Cures Act’s entire purpose was to expedite getting these drugs to patients and providing affordable access to new breakthrough drugs more quickly and to cut through unnecessary delays and red tape. There is a particular focus on expediting access to drugs targeted at genes and protein targets and cell therapies.

It’s all new. But that is what is happening, NOW.