Speculating on Tysabri Trials

on friday, i jumped back into ELN with a purely speculative position because of some new information that i picked up. i came across several posts on the yahoo msg board stating that tysabri patients are known to relapse 6 months after treatment is halted. i verified this information by searching through ThisIsMS, a multiple sclerosis community which is pretty unbiased.

in this article, the author states that: "Previous studies (Phase II) showed that patients who were taken off of Tysabri treatment had relapses begin recurring after about 6 months– though there was no rebound above the level seen in the placebo patients. Therefore, the FDA will theoretically be aware that MS patients in the Tysabri trials before the marketing suspension are reaching the point where they should begin relapsing. As such, there is a sliver of hope that re-dosing of former Tysabri clinical trial patients could begin by early September 2005. To be clear– This is SPECULATION. However, note that it is easier to restart clinical trials then it is to re-introduce the drug to the general market."

this is interesting. the 1808 trials were suspended around february 28th. today is august 6th, a little bit more than 5 months since tysabri was pulled. august 28 will mark 6 months since tysabri infusions were halted.

both elan and biogen made it very clear in the Q2 conference calls that they plan to resume clinical trials for patients who are at high risk. therefore, if the FDA's interest is to put patients first, there is a chance that they will try to resume trials before the august 28th. the reasoning is that the FDA will be criticized if they delay the resumption of trials if patients in the 1808 study relapse since the FDA (according to ThisIsMs) is aware of the 6-month relapse statistic.

of course, like i said, this is highly speculative, but according to elan/biogen, its really just a matter of weeks before trials resume. i'm not sure if trials will just restart all of a sudden, or if eln/biogen will need to submit any formal requests/data before the FDA gives an OK.

i was burned by this stock last week when i was speculating on their Q2 CCs, so i'll be speculating carefully. good luck.

DISCLAIMER: I personally hold long positions in ELN, and this post is purely speculative.