Replies to post #521910 on NorthWest Biotherapeutics Inc (NWBO)

[LearningEveryTrade]

I agree with Midwest Hedgie on this one.
Landmark OS on hard to treat GBM is very well received by shareholders. It's non-shareholders that are upset.

Primary endpoints are what get's approval.

[biosectinvestor]

Apparently you're wrong and the State of Washington reviewed it very carefully, in a manner that apparently escapes the ability of some to drill down into the report and confirm fact from implication, or fact from fiction. As I've said before, the standards are lower for devices and they did not run this out long enough to actually get real survival data across the board to 5 years. Follow-up was to a median of 40 months.


https://www.hca.wa.gov/assets/program/tumor-treating-fields-final-report-20181016.pdf



Thanks to Hoffmann. I had seen this before, but he posted the details.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=169574535

Similarly, the UK has made a similar assessment and determined it is not worthy of funding for anyone but the youngest and most severe patients. There is a lot of political pressure and I'd weigh in to give it, even though it is outrageously expensive over time. But if you run a huge program and have to decide who gets what, apparently the benefit is not enough and the evidence is weak to prove it.

I presume NVCR needs to get all their money as quickly as possible, which must be the reason it costs $21,000 per month forever. If they really thought patients were going to live so long, they could probably afford to charge less. The pricing speaks for itself.

For DCVax-L, if it cost $220,000 for a 2 year course of treatment, not sure exactly of the pricing yet, but people have estimated this much, then that is $9,166.667 per month if the patient lives to 2 years, and decreasing for every month exceeding that 2 year mark. That seems much more doable. The Median OS was 19.3 months, taking the more conservative measure, so $11,398.96 per month then, and decreasing for every month surviving.

For mMGMT patients, median survival was 30.2 months, taking the more conservative measure, so $7,284.77 per month, and decreasing.

I would bet that a regulator, looking at this and then looking at preliminary data with adjuvants and combination therapy potential, plus the fact that recurrent has no current standard of care, would be very favorably inclined here to give patients a real option that probably will also expand to other cancers and is extremely promising as a major new addition to the oncology toolbox across oncology as well as GBM, it has mild symptoms, has patients living as long as 19-20 years without recurrence, and has much more data that it seems is yet to come that will make it very impressive for regulators to approve. And this is a disease that is almost always fatal, and this trial has outshone all before, for a biologic or drug.

[dstock07734]

When you talk about 13% OS after five years, don't forget that about 7% of the patients were IDH mutant type.

Dr. Stupp was the first author of the paper. Get yourself psychologically ready that he would be one of the coauthors in the DcVax paper.