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Idunno

11/20/22 3:29 PM

#536203 RE: learningcurve2020 #536201

Afternoon, LC.
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Reefrad

11/20/22 4:31 PM

#536215 RE: learningcurve2020 #536201

Lol. Nice disguise.
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thermo

11/20/22 4:31 PM

#536216 RE: learningcurve2020 #536201

I think we’ll see a push to commercialization in the UK very soon.

The use of external controls will remain controversial right up to any regulatory approval and this won’t come just from some investors/pundits/bears but also from some in the medical community.

The doctors that I spoke to who participated in the trial are universally and strongly behind the therapy. But I’ve spoken to others, not involved in the therapy, and was surprised to hear they were generally supportive. Safety + unmet need is a strong motivator.

The real transformative opportunity for DCVax is when used in combination. But those trials never get done if DCVax doesn’t get approved. A 2nd Ph3? Similar problem.

The NovaCure device has role, but it would be a mistake to bring further DCVax development (combos/other cancer types) to a halt because NovaCure serves a certain subset of patients.

Any regulatory decision brings a certain set of consequences. Approval seems like the better choice if the objective is to serve the interests of cancer patients.
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biosectinvestor

11/20/22 4:39 PM

#536219 RE: learningcurve2020 #536201

Novocure / Optune is not a systemic treatment and is no substitute for one or for an immune I therapy either. It’s statistics are also subject to not just significant questions from critics or top doctors, which is true, but also from significant regulators, in the UK and US.

I have no doubt that people could write an article. I doubt that will affect regulatory approval.

As for signs of pending effort to get approved, everything they have done for 2 years and PR’d is an indicator of their work toward getting this approved. It is nonsense to say otherwise. Everything they are working on is a significant piece of the final application for approval. Manufacturing a drug like this, after the data, is probably the single most significant piece that the regulators will look at for approval.

Novocure says a lot that seems inconsistent. As for treating 30% of all patients, that does not sound right and I’d want to them know why so many managers are selling and why their stock price has been going down significantly rather than up. Their revenues certainly do not reflect that kind of uptake given how much they charge. They should be rolling in huge sums of money if 1) they were taking in that many patients and 2) if their patients were living as long as they suggest. That contraption likely costs noting to make at this stage, and it would all be money. Charging 21,000 per month, as long as the patient lives is an outrageous sum. And that is, in fact, the rate. Insurance covers it here. They will need to negotiate it down in the UK. The UK regulator does not think it really performs or is worth it for most patients. The State of Washington agrees. Those are probably not the only two authorities who think that way.
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PalB

11/20/22 4:45 PM

#536221 RE: learningcurve2020 #536201

I am not sure what you are trying to imply. As I know one of my friend treated with Novacure, no comparison and never had chance. Her pretty much all Institutions involved in the trials and Researchers agree. If not approved it is the big pharma playing the games.