black-box and dosing limit

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

black-box and dosing limit

Postby batpere » Wed Mar 02, 2005 10:28 am

Read this in an investor's daily journal today:

Merrill Lynch analyst Eric Ende wrote the most likely outcome is that Tysabri re-enters the market in six months with a single-agent use (i.e., no avonex), a two-year dosing limit and a black-box safety warning.

And further, " In this case, Tysabri sales could be reduced by more than 50%". I'd say probably more like 90% reduction. I personally really wanted to use it, but I doubt my wife would let me try again even if they do bring it back to market.
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Postby OddDuck » Wed Mar 02, 2005 10:38 am

Too bad they didn't do that up front, though.

Shoot, if somebody like little stupid peon me found the medical and corporate evidence that I did (months ago) and then pushed for the very cautions and protocols you just said (in my letter to the FDA and others), then I still am just literally shocked and dismayed to think that supposed higher learned professionals than me and governmental entities couldn't see that same thing.

Either that or I'm WAY more intelligent and underestimated than I thought, and worse yet, WAY underpaid!!!!!! 8O

Deb
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Postby reed » Wed Mar 02, 2005 3:18 pm

OddDuck wrote:Too bad they didn't do that up front, though.

Shoot, if somebody like little stupid peon me found the medical and corporate evidence that I did (months ago) and then pushed for the very cautions and protocols you just said (in my letter to the FDA and others), then I still am just literally shocked and dismayed to think that supposed higher learned professionals than me and governmental entities couldn't see that same thing.

Either that or I'm WAY more intelligent and underestimated than I thought, and worse yet, WAY underpaid!!!!!! 8O

Deb


Dear Odd/Deb:

I'm a new member and avid trying-to-catch-up reader who had the misfortune to have his first dose of Tysabri on February 25th. When I called the nurse practitioner on Monday, she seemed surprised that I had "heard" so quickly. I told her I hadn't!

I've been reading a number of your postings, and my preliminary view is that, indeed, you are way more intelligent, underestimated, and underpaid than many so-called experts in the MS arena. I take my hat off to you. I wish I had read about your research and your regimen before last week.

I was particularly unimpressed with the NMSS expert's opinion that you need to get beyond "mere" symptomatic relief if you want to have a shot at a serious research project. Please tell him there are many patients in the world for whom symptomatic relief will do just fine.

All my best,
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Postby OddDuck » Thu Mar 03, 2005 3:25 am

Hi, Reed! Welcome!!!

Oh, thank you so much for your kind words. :oops: Actually, since my original communication with the NMSS, and with our continuing communications over the past year, they have indeed become convinced that I have now provided more than sufficient evidence to prove biological substantiation and justification for investigating my theories. Although, that is where it is "stuck" at the moment.

Please tell him there are many patients in the world for whom symptomatic relief will do just fine.


As a matter of fact, I believe I have said that many times. I know exactly how you feel!

Again, welcome to the site! There are lots of wonderful people here.

I hope you are doing well (?)

It's nice to meet you.

All the best to you!

Deb
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