It would send shock waves through the whole Biotech and Pharmaceutical industries worldwide if the FDA doesn't approve Tysabri. The Biotech index in the U.S. and Europe would tank. If a drug with the safety profile of Tysabri can't get approval from a shakey FDA then what drug can? Would it be worth it to spend billions to develop a drug and risk having an overly cautious safety obsessed FDA shoot it down because it's not perfectly safe?
The FDA's decision on Tysabri is being watched very carefully by all Biotech and Big Pharmas and a bad negative decision would cause serious adverse events in medical, financial, and Bio/Pharma industries.
The Tysabri decision is going to be big, one way or the other. If the FDA gives Tysabri their blessing it will be a big positive event for all the industries stated above. Watch the entire Biotech index start moving up the day the FDA gives the OK for Tysabri.
Don't anyone underestimate the importance of the FDA's decision. It will be the NEWS of the day on Wall Street but will also be a major topic of discussion for a long time after that.
Persiflageur is definitely a chicken
He's wrong and he'll fry for his assumption that FDA won't approve Tysabri.
I have no respect for this chicken longs like this who don't believe in Elan science.
If the FDA does not approve TY & IT HAS ANY CURATIVE ABILITY after the euro approval we will see some state-side heads role.
(totally Ir-respective of any knowledge but knowing only the truth can ruin careers even CEO's of BIIB)
persiflageur is an egomaniac who thinks he knows all. I think all his postings here are useless.
I think he sold too soon and wants to get back in cheap. Too bad, because Tysabri is a sure approval.
Persi you're too stupid to reason with. I just mentioned about the FDA official resigning. Guess what! I know the story and you assume otherwise. That's just what I said, jerk!
And secondly, if you don't believe in the safety review conducted by Elan. GO TO HELL
I can't fathom that they will not approve TY. That would be devastating to the MS'er. I think they will only approve mono therapy.
I am shocked that the FDA panel recommended approval of Glaxo's diet drug to be OTC. I think this is a really bad decision.
<<The FDA's decision on Tysabri is being watched very carefully by all Biotech and Big Pharmas and a bad negative decision would cause serious adverse events in medical, financial, and Bio/Pharma industries. >>
Grown men will weep and women will faint, or vice-versa, the sky will darken for 40 days, there will be 7 years of famine followed by 7 years of plague, disco will return, etc.
The chief issue re TY before the FDA is: what restrictions, conditions, warnings, cautions, etc. (if any) should be added to TY label and what screening, testing and/or monitoring should be done for those seeking to use TY.
Note: Ty was approved on 11-23-04. Consequently, approval for efficacy is not an issue.
>>Grown men will weep and women will faint, or vice-versa, the sky will darken for 40 days, there will be 7 years of famine followed by 7 years of plague, disco will return, etc.<<
For God's sake not disco!. It may be well established to most on this YMB that the AC and FDA decisions are mere formalities but there is still much doubt in the rest of the world or else the PPS would be much higher than it is.
>>Grown men will weep<< If Tysabri isn't approved for reintroduction then you are certainly right on the money with that prediction.