Replies to post #650408 on NorthWest Biotherapeutics Inc (NWBO)

[Legend431]

Funny how you are calling out ex about what he said yet you must have forgot how many times you said submission was going to happen in October. I have been looking but haven’t seen you say you were wrong :-)

[skitahoe]

Hoffman, while what you say has a degree of truth, but not completely. First, do no harm, has a lot to do with the regulators thinking. When a product has been proven not to be harmful from prior trials, the FDA generally will permit it's use to be tried against a variety of diseases, as long as someone is paying for the trial. CVM has done this many times with the very same drug, no modification or improvements, simply trying the drug on a different target, often in a Phase 3 trial, which they're permitted to do. Decades ago I made a small investment in CVM, but at that time the company while called CVM had actually changed their symbol to HIV to highlight the fact their drug was being tried in AIDS. Of course it failed, the symbol was changed back to CVM, they did a reverse split and shortly thereafter announced their intent to do a new Phase 3 against a new threat to humanity, I forget what it was back then. I sold out, took my losses, but watched them repeat this pattern many times over in the ensuing decades. Who knows, maybe this time their cure has found its disease.

Now if their product had not previously proven itself safe in a variety of cases perhaps the FDA would insist on new Phase 1/2 trials, but it has and they're permitted to schedule new trials as long as they - first, do no harm.

In some way, at some point, this might be applied to our vaccine as well. If NWBO, or a partner of theirs, after approval of DCVax-L were to propose adding DCVax-L to the protocol for a solid cancer in which the partners product had shown to do no harm, I don't know that a Phase 3 couldn't be tried, even though Phase 1/2 were not done with that protocol in that cancer. I'm not saying this will happen, just looking at possibilities. Such trials are expensive, even a BP with seemingly unlimited funds may want a small Phase 1/2 before proceeding with such a course. Clearly UCLA won't fund a Phase 3 by themselves, they've produced the needed data, now it's up to others to carry them forward. I believe that if DCVax-L were approved anywhere, new trials would be initiated by one or more BP's using their therapeutics along with DCVax-L.

Gary