Don't forget the clinical data compiled and presented from the 2 year endpoint and safety review data from the AFFIRM trial met and exceeded the data presented from the one year endpoint in both SAFETY as well as never seen before efficacy for a gold standard, standalone indication of this fantastic novel therapy for MS!
Call me an idiot or crazy if you wish but, I already know I'm a slowly progressing veteran MSer and willingly able to make a well informed choice when Tysabri returns.
TheTysabriBull wrote:Comparing the data and endpoints with other mutually exclusive clinical trials is unscientific methodology.
Please show me where any of the ABCR drugs showed 28% SUSTAINED disease reversal by 100% mitigated disease progression in any of the previous clinical trials or commercial patient population?
What is the overall safety profile of all the ABCR drugs in regards to the collateral damage incurred by these ineffective MS drugs relative to the actual damage caused exclusively by the disease itself within the entire MS population?
You don't have to convince me about the minimal efficacy of the CRABs. They have been overrated for years and are a cash cow for the companies who make them. These companies have spent millions on extension trials trying to prove that their CRAB is better than the next guy's! And Biogen has been right in there with Avonex.
You really don't think that the CRAB drug makers would give us that information, do you? I know 3 MS patients who took a CRAB and saw their disease progress so quickly and aggressively it made your head spin!!
At the same time, I also don't trust Biogen when it comes to divulging all the info on Tysabri. Their reputation in the medical world is quite poor in this area. Let's just say that if they had handled the introduction of Tysabri differently, I believe the drug would be in use today under much stricter guidelines.
if the experts can't or refuse to figure why PML occurred in the Sentinel study, I feel very confident to safely resume dosing of Tysabri as a standalone monotherapy for my MS.
"Tysabri showed 28% SUSTAINED disease reversal with 100% mitigated disease progression in the AFFIRM trial as never seen before efficacy in any of the MS CRAB drugs."
Good one Harry. You know of 3 MSers. I know of thousands and thousands. What took you so long to figure that out? Don't you think the ABCR companies had us MSers really fooled? It wasn't hard. Those approved MS drugs is all we've had. If MS was a type of deadly CNS cancer, most of us would have been dead by now.
Harry, at some point you should consider trusting some one more than just yourself. I think I'll trust anyone who had least tried the drug and all the docs trying to figure out what caused the PML in the Sentinel study. It doesn't appear that Tysabri was the direct cause of PML. Tysabri may have been a convenient accomplice with Avonex while possibly being dosed to a couple of trial patients who may have had another form of demyelinating disease other than typical MS. So in other words, if the experts can't or refuse to figure why PML occurred in the Sentinel study, I feel very confident to safely resume dosing of Tysabri as a standalone monotherapy for my MS.
MS patients didn't hear about PML until Tysabri came along. This drug is a powerful, immune system altering medication and it needs a lot more study done on it....far more than Biogen/Elan gave it prior to approval and general use. The good thing that has come out of all of this is that when Tysabri starts to get used again, the monitoring of MS patients on it will be far greater than ever before. I'm sure that the FDA will mandate that and will require a "black box" warning for the drug. This is what should have happened in the first place.
Harry, no one twisted your words. You're the one that gets to type what ever you feel like debating about at any given time. Have you noticed that I have the same equal time you are afforded in this unbiased-open forum?Please don't twist my words and say that I don't trust anyone.
MS patients didn't hear about PML until Tysabri came along.
I'm sure that the FDA will mandate that and will require a "black box" warning for the drug. This is what should have happened in the first place.
Logical deduction: If many common presenting symptoms of MS are remotely similar to forms of other active, bacterial or viral demyelinating disease such as PML, what fraction of all deceased MSers may have been historically assumed to have died from complete shut down or failure of vital bodily functions controlled by their once healthy CNS? Do their death certificates simply state MS as the cause of death? I'm curious.
Harry, no one twisted your words. You're the one that gets to type what ever you feel like debating about at any given time. Have you noticed that I have the same equal time you are afforded in this unbiased-open forum?
Harry, its about time us MSers and all of all of our so-called specialists, experts, and practitioners learned about PML. Harry, drug induced PML has also been occurring in the non HIV/AIDs patient population for many years. The drug induced PML safety issue is not only an issue with MS patients! Think about it.
So you're betting that the FDA is going to re-approve Tysabri very soon? I'm thinking it will be approved... but later rather than sooner.
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