Replies to post #535695 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

Im sorry but that's not how it works. Every MD will refer to the SOC when it comes to a cancer indication (for example Trodelvy for metastatic triple-negative breast cancer) since that's what protocol dictates and what medical literature refers to. Also all MDs especially oncologists will almost never refer to a nonproven treatment which in fact DCVAX L is for all other solid tumor indications outside GBM.

Second, the insurance companies will NOT reimburse alternative non-approved treatments. Yes some MDs may refer to medical trials with exciting new treatments but as long there is no running new P3 trial for DCVAX there will no be referring.

Btw from what I have understood. NWBO stopped producing DCVAX for other indications outside GBM so there is that.

[biosectinvestor]

People telling you otherwise are not up-to-date on the changes under the 21st Century Cures Act. It will be much easier to get the drug prescribed for other cancers once it is approved both for off label use and for extending the label and they can use what is called real world data to get it and get insurance coverage not for off-label prescription as well as for extending the label.

It may not necessarily be immediate but NWBO will need to get up to meeting demand for GBM and other brain tumors. But the fact is, going forward under this new regime of regulation, law and guidance, it will be far easier to expand access to many patients with different kinds of cancer and get it covered by insurance with patient records and far more informal evidence, not necessarily clinical trials, and for a drug with low side effects and a relevant immune reaction potentially, getting the drug will be even easier than for more toxic drugs with serious or life threatening side-effects.

More likely however, they will focus on just meeting initial demand first.

Also, combination therapies are likely to be much easier to get through under the 21st Century Cures act, especially where both drugs have had an initial approval.

But I do not expect the market to understand this fully at this time because these new rules are only really just being initially implemented. It will take a while for the market to realize how much more liberal the rules have become and what impact that will have on drugs of all kinds but especially oncology drugs.

[br8k0ut]

Yes, it's called "off label" use. Docs can certainly do this. Only problem is insurance. If a drug or treatment is not on formulary and/or extremely expensive, insurance is likely not gonna cover outside of a GBM diagnosis, and a prior authorization will likely be needed. Good luck getting that approved on a drug with a price tag like DCVAX-L