If no cases of PML were found in patients taking Tysabri monotherapy, what is the risk that a patient receiving Tysabri would develop PML? Stumped?
I'll answer it for you- ZERO!
Since no patients have developed PML while on Tysabri monotherapy, how can you quantify risk with no endpoint(patients with PML)?
That's what Phase 4 is for. Tysabri monotherapy should be back on the market in no time.
I didn't realize I was dealing with a novice. Sorry about that. So you would like a "relative assurance of safety"? I'm assuming you mean a drug with absolutely zero risk to the patient. That drug does indeed exist-in LaLa land where you spend most of your days. In your warped view, BIIB should perform a 20-year study on the safety of Tysabri monotherapy to ensure that the miniscule risk of contracting PML is just that, miniscule. Did you know TNF-inhibitors increase the risk of PML in patients? Study up genius.
I would be very careful about shorting BIIB here.
"and he is pursuing avenues that use the same mechanism but are much safer"
Yeah, in rats and mice. Last time I checked, rodents don't have $20k for annual treatment. Perhaps it may work on dogs...souldogs...
Any human data on his alpha4 antagonist? Any 2 year data on 1000's on pts?
Oh I am sorry that I gave you too much to read.
Steinman pioneered the theory and initial lab work that uncovered the mechanism by which Tysabri works, back in the 1980s.
Yes, he works as a drug developer, and he is pursuing avenues that use the same mechanism but are much safer. Are you suggesting that, with his expertise, he shouldn't develop drugs?
Are you suggesting his warnings that T could lead to infectious diseases of the central nervous system are invalid because he is in the field?
Funny that they turned out to be spot-on.