Tysabri Chatter
By Johns Wu on Sep 13, 2005
As we get closer and closer to the September 21 "deadline" by which Tysabri reviews should be completed, the chatter is getting louder and louder. If you haven't been following the Tysabri saga, the September 21 deadline was subtly announced by Biogen Idec (BIIB) officers in their Q2 conference call a month or two ago.
There's definitely something going on. A few days ago, Biogen Idec announced that they will be cutting their workforce. The bears speculate that Biogen expects the FDA to roadblock Tysabri's return, and thus is restructuring. However, the bulls speculate that Biogen expects Tysabri will return as a mono-therapy, effectively making their Avonex franchise obsolete, thus calling for job cuts.
I'm frustrated by ELN's and BIIB's silence as analysts (Morgan Stanley) and crackhead journalists (re: Jeff Krasner of the Boston Globe) take cheap potshots at both companies. These potshots have halted the recent rally in both companies and are giving shorts an opportunity to cover at a discount.
Regardless, because it's getting close to 9/21, and because of the increased chatter I'm hearing this week, I'm holding a speculative position in ELN, and I'm hoping for some good news real soon.
DISCLAIMER: I hold long positions in ELN and information in this post is highly speculative.
UPDATE: I listened to both calls from ELN and BIIB from awhile ago and I noticed a huge discrepancy. BIIB seemed to imply that safety review data will be handed over to the FDA by September 21, while ELN implied that an FDA decision would be made by September 21. I don't know what to make of it.
9 Responses to “Tysabri Chatter”
it does not say that. ameieve is being sold so obviously sales force will be cut, but it does not say that only ameieve salesforce is being cut. did you bother to read the PR?
all I will say is that it is great to know things
Nice name for a drug.
Natalizumab bamuzilataN
Well, let’s just short BIIB for the sake of hedging then.
In case the selling is misguided, cover around 42. Yeah?
Does anybody care that there are real people out there who are seriously ill who desperately need and want this drug??
My daughter got only two infusions and was helped tremendously, only to have the drug taken away, the good effects to gradually go away, and now a long wait for a bunch of people who don’t give a damn about anything but money to get this wonderful drug back on the market.
Why can’t this process at least be more transparent?
Waiting
There should be no shock that discussions of a financial nature are taking place, just a matter of fact.
The two drug companies are rightly concerned about money on two fronts: 1) no FDA final approval equals less projected revenues from years of R&D and 2) they have to worry about lawsuits years out.
Meanwhile, the FDA has had its share of bad P.R. recently, so I’d expect they’ll err on the side of caution.
I reckon many people care, but red tape usually sets its own ETA. Best wishes for your family.
where did your more recent commentary regarding ELN go? It mentioned the ERCTRIMS conference in Greece at the end of next week. It was a very good summary for the masses.
I’m with the mother advocating for her daughter. As an MS sufferer, I am hoping desperately for a new advance and am WILLING to chance it for quality of life…what about us?and I’m sickened by all the tort attorneys waiting for the next big cash in - shame on them.
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if you bothered to read the press release rather than just the headline biib say that the sales people being let go are the ones selling amevive. They also go on to say that tysabri is one of their near term expectations of re-introduction