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Originally Posted by Riverwild
#2: Avonex is now more expensive than Tysabri. Do you think they are pulling a Cephalon move? Cephalon increased the price of Provigil to try to force people onto Nuvigil, since provigil is going off patent. If they can get people on Nuvigil, they retain the $$. Biogen owns Avonex and owns part of Tysabri. Avonex is going off patent soon and any pharma with biological production capability can start making Avonex. Where do you suppose Biogen wants their patients on Avonex to go?
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Biogen extended the Avonex patent out to 2026 so it doesn't have to do with patent extension - just greed. Sad that drug price cost has nothing to do with efficacy/relative efficacy.
Quote:
Originally Posted by Riverwild
#3: The assay- The FDA is already in trouble for what's been going on with pills and meds-think Avandia. They are going to be VERY careful before approving anything. Ask yourself why they would require a two year trial of a simple blood test. I understand they may need to find where "statistical significance" is, and that the neurologists will get the results, but do they actually think that any good doctor is not going to disclose results to their patient? The patient will be cautioned about trials and stat sig, but the result will be there, negative or positive.
Speak with your neuro if you want this test.
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The 1000 patient trial is a prospective study to prospectively determine the accuracy of the assay (blood test) relative to JC virus present in urine (PCR testing). They should be able to determine accuracy/market the assay after the initial tests of the 1000 patients. The 2 year timeframe may relate to determining the percentage of patients who go from negative to positive over the two year period.
The 8000 patient trial is being run to show the risk of PML for those who test negative on the assay. Given that you can't develop PML without the JC Virus, logic would say that the risk of PML for those who test negative is negligible but you can't put that in the label without clinical proof.