Replies to post #601761 on NorthWest Biotherapeutics Inc (NWBO)

[OncoJock]

In some ways I agree with you, Crash.

Your point about DCVax targeting many hundreds of tumor antigens, as opposed to just a certain peptide like the SurVaxM product, is well-taken.

And, to take your comparison even further, SurVaxM will always only target the survivin molecule, which means that its chances of overcoming tumor resistance and evasion are roughly nil.

So I'm not arguing with you on these points.

The point I'm trying to argue is that NW Bio may not be the first company to win FDA approval of an advance in systemic therapy for GBM since temozolomide (Temodar) in 2005. I'm saying MimiVax LLC MAY (emphasis on the MAY) beat us to the punch, depending on the results of their large Phase 2b randomized, placebo-controlled trial that (according to ClinicalTrials.gov anyway) is scheduled for completion next spring.

I'm thinking the decision to run a large, phase 2b trial (as opposed to a phase 3) was very savvy on their part, because it could help them reach the finish line years sooner. In this scenario, they'd get an accelerated approval based on results of the 2b, then have to run a full phase 3 to convince the FDA to convert the accelerated approval to regular full approval.

I've only been a NWBO shareholder for 2 years, but others on this board say they've held shares for 5, 10 or even more years. I think for MimiVax LLC to cross the finish line first would hurt.

But that might not be all bad. Personally, I think a little competition can be a good thing. First and foremost, patients would benefit from a greater variety of treatment options. Also, competition can focus our attention and our effort. It can draw attention from onlookers who otherwise might not be so interested. It can help prove the concept of a brain cancer vaccine, and it could help grease the skids, so to speak, for uptake of DCVax when it finally gets approved.

-- OJ

[exwannabe]

Nothing competes with DCVax that targets many hundreds of protein sites on the tumor. As somebody who claims to have a hard science background you should know that. Though I guess a social science layman like myself understands oncology more than the "jock!"

There is also plenty of reason to believe that targeting the entire lysate is not ideal. Those targets will overlap with self targets. OTOH, specific targets can be better targeted.

The whole tumor lysate concept was first tried in the mid 1990's with no luck. That said, some think it is still a way to go. Not even the top researchers in the world know the full answer to these questions, but I guess it is obvious to social science laymen.

What I do know is that it takes quality trials to prove any implementation in this space works. And a trial that has the placebo arm outlive the treatment arm is not such.