Vaccine May Stop Lung Cancer

[Wulfman]

Originally posted by The Rock
So these guys want to apply for FDA approval in 3 years. The question is: exactly why does it take 3 years?

doing tests if everything is safe, repeating them. using other tests, other conditions, combining with other drugs. doing the tests again. adding risk & minor important groups... doing the tests again.... and again.

at least that is the impression I got when reading about stuff like that - imho 3 years is rather fast: not long enough to recognize long-term-effects.

mfg
wulfman

[The Rock]

That makes sense (the long term thing). But I would think that if I had severe lung cancer, and only had 6 months to live, I'd like the opportunity to gamble on the drugs long term effects. Too bad there wasn't some "intermediate" approval that would give people who have no chance of living another 12 months the ability to volunteer to be guinea pigs. I'm guessing that without FDA approval, this couldn't happen?

[az]

You could always volunteer as a tester - they need test persons before approval.

AZ

[Brian R.]

Originally posted by The Rock
So these guys want to apply for FDA approval in 3 years. The question is: exactly why does it take 3 years?

I have a habit of over-analyzing processes/procedures at work, constantly analyzing in my head how we do things, and could be do them better. So I see this 3 year wait and I'm thinking "is something constantly being done over those 3 years to get that drug to the people who need it?". I wonder how much "idle time" is wasted in those 3 years because of red tape and drug industry processes. Maybe it's as efficient as it can get, I dunno. I'd like to hope so. Very curious about this whole thing. Great news for cancer treatment advancement though.

From the brief account given in the link above, it appears that the vaccine is still in the experimental stage. You can't submit a Biologic application with only an experimental vaccine. If they are currently making the vaccine in 10-dose quantities, they will have to figure out how to upscale to within a certain percentage of manufacturing scale before their treatment is ready for submission. The quality of the vaccine in the larger-scale manufacturing must be equivalent to or better than that in the smaller-scale batches.

They appear to also be applying for an indication of prevention. I would think that they will have to run the clinical trial for at least as long as they want to claim. They said that it prevented reoccurance for three years in some patients, so that must be one consideration in the application. They will probably initiate a new more extensive trial as soon as they can obtain the clinical supplies. Then they will establish a larger-scale manufacturing procedure during that time to submit to FDA once they see similar efficacy as they did in the small-scale trial. This timeline is their hold-up to submission. There is probably little time needed to approve this once it is submitted, assuming they can prove efficacy and a modicum of safety.

I think proving the efficacy of a vaccine takes alot longer than just proving cure efficacy. As soon as you can prove the patient is clear of the disease, then you have data. Vaccines need to be evaluated long-term.

In answer to your more general question, no, it is not as efficient as it can get. Don't get me started on how this could be changed...

[NuGGeTTi]

hope theyll make a vaccine that actually works