up to now this must seem like a laugh-a-thon at the SEC when they look at the complaints that must be filed over BIIB's handling of this situation - meanwhile they are buying back shares through ML
not to mention Panzera sending out inside info by e-mail to neurologists saying that suspected PML patient #4 was negative for JC virus and was never considered a suspected PML case
at SG Cowen on Mar 16 Mullen says review will take "a few more weeks"
At beginning of april - rastetter says - review will done in second half of year
after the Q1 CC Mullen said on CNBC - no more PML cases - during CC he says review will be complete by the end of the summer
then he says on AGM CC that he is blinded and that review will be complete by end of summer
but if he is blinded then how does he know when the review will be complete and why did he say no more PML cases on CNBC
If he is blinded - then how can he lead his company and make decisions on the future of tysabri and how can he give any statement on it
funny how he just decided he was blinded at the beginning of june but he was willing to give comments and time frames before then
now if the review is done and Mullen says that it will be done at the end of the summer what do you do - does someone ask him why he won;t admit the review is done - will someone ask him tomorrow on the CC if he is blinded? - when he will determine if he is unblinded - at what point he will unblind himself ? - the reason he said he was blinded? - was he really blinded but still speaking on the subject?
I think once and for all the BIIB folks need to just tell the truth and quit making such a game out of these suspected PML cases, the status of the re-review and the path for tysabri coming forward
or maybe the SEC could help them out a bit
I note that they were responding to the FDA concern shown in 2.5.2 on that drug app, but perhaps folks should rub the Boston Globe, the WSJ, etc. noses and other random anatomical parts in those statements.
I still think they should/could have forward predicted this and I think that they were foolish to proceed with the Avonex+Tysabri study in light of that. It has put a good product in harm's way, burnt the MS community, hurt the shareholders and all the rest. Their approach so far has not done anything to help the company or anybody else. I guess that they do not care if NVS or some of the other companies fall into the same trap, but it is not going to do the MS patients much good. Especially with guys mouthing off about doing multi-therapy with things like Betaseron+Cellcept.
I agree they may not be the sharpest although a post was made in reference to removing someone from the company: the combo test most likely was a product of greed more than anything, even though results could be predicted...those who did give the nod may not be ethical at all and pose future malice.
Past tense for me now. Since I wrote my stuff earlier somebody took my position off my hands. No complaints, I bought it when they dumped on BIIB over the NVS drug, etc. so I made a little money on it. But still. It will be a long time before I go back into this thing. There is somebody someplace in that organization that the shareholders (no longer yours truly thank you) ought to get rid of asap before more bad stuff happens.
Here's the original application for Tsyabri
Go to secion 2.4 (pages 15, 16).
I'm not a biologist, but it looks like BIIB was always wary of combo treatments.
Pin, my problem has to do with the fact that they should have forward predicted the Avonex+Tysabri PML problem but somebody didn't think. Or if they thought, they were over-ruled by somebody else in the organization (even worse).
You know my thesis: Normal CD4 counts are 500->1000. Tysabri reduces T cell trafficking by 60%. Thus you have an equivalent CD4 count in the brain of a person with a CD4 of 200->400. Low, but you do not see PML at that level. Add in the Avonex and shift the T cell profiles from a th1 cytokine profile to a th2 cytokine profile with an efficiency of 50%, and you now have somebody who has the same anti-virus efficiency in the brain of a person with a CD4 count of 100. Guess what you see in the HIV population when you get to a CD4 of 100. It ain't fun, its PML. Not the rampant 5% you see at 50, but you start to see it. So guess what they saw... It should have been predicted by anyone who thought the problem through.
The MS folks are going to see the same with Ceppcept+CRABS or the NVS drug + CRABS or ... BIIB better get with it. This is going to start to hit home with Avonex if they don't.
I have a small position in BIIB (2.9K shares). I hope to make that past tense by the end of the week. There is something, rotten in their organization.
Your thesis is sound, in fact, "equivalent CD4 counts" could well be the ultimate prognostic factor in risk management for MS patients taking Avo and Tys together.
Just wonder out loud if BIIB/ELN has a weaker version of Tysabri around. One with a much shorter systemic half-life or weaker binding coefficient? If the Tysabri impact can be reversed after a month stopping the dose (instead of 3), and with a blood test and proper risk management, Tysabri should be a viable and safe product in the market place.
I think that avonex also increases sVCAM that competes with tysabri for VLA4 and thus increases half life of drug and reduces clearance - but over time this might be amplified so you get severe tysabri overload caused by avonex - might be that these people have other genetic susceptibility for this to happen in combo - still not enough info from the NEJM cases to figure that out - but the FDA commented on the avonex effect on ty even before ty was approved - they seemed to errorneously think that just because much higher levels of ty wasn't toxic that it might not lead to other problems
tysabri accumulation of lack thereof is probably much more straightforward in the absence of avonex and that is why no problems have surfaced with ty mono use in non-immune suppressed patients
I think that for combo to ever fly again they need to show that av + ty is better than ty alone