A story in today's Health News Daily. Roche is strengthening warnings in European labeling of Rituximab because of 8 fatal cases of severe cytokine release syndrome. IDEC and Genentech are discussing Rituxan labeling revisions with the FDA.
If I were Idec I wouldn't give an inch either. I doubt the same holds true for Genentech or Hoffman. Let's face it. 10-12 thousand doses of Rituxan have been given and we are NOT hearing about all kinds of cures. Now we hear Rituxan has triggered some deaths. I can understand how a massive dose of anything can imbalance a sytem but they are saying some deaths are due to offlabel use. Doesn't that mean the intermediate and higher grades of NHL, or 2/3 of the new cases? Why haven't we heard anything about these 60-70 other trials, the ones in the higher grades? Idec has never been short of good news rumors. Where are they? Maybr they'll give us some answers at the upcoming AS of H meeting. It was a war between Rastetter and Bigham (CLTR) last year. IDPH has been good to me, I've been long since 1995, but I'm not about to put on blinders.
Partner, never. IDEC right now stands on their own, why buy partners? And why does TCLN have intermediate and high grade non-Hodkins lymphoma to themselves? Is Oncloym 1 that good? Nah, just hype. Hopefully their human trials on their other technologies isn't competition. I meant they might be worth buying for short term, they won't ever get to 30 bucks a share.
Or maybe a partner, it depends on who they license to. They seem to have intermediate and high grade non-Hodgkins lymphoma to themselves. They haven't said a word about their phase 3 but we didn't either during ours.
I think Coulter is a bunch of hypesters with a lot of cash. How can they expect to get FDA approval based on one trial of 60 people when only 32 are evaluable? Get real! Between Idec and Techniclone there isn't much NHL left for them to treat.
from her morning notes...."the emea announced rec. for use of rituxan, due to rare severe but easily preventable advers reactions, which resulted in 8 deaths, some in patients that were treated off label, among the 12,000-14,000pts treated to date........pre-treatment with anti-histamines and corticosteroids can prevent /minimize the reaction and is currently in the us rituxan product label. we expect a dear dr letter shortly, but do not anticipate any impact on drug use...""
" the rxn tumor lysis syndrome , results from the drug's extreme efficacy in killing tumor cells.." bottom line is this is an over-reaction....she re-recommended her buy with a $50 target...and eps for 98 of .72 99 eps .89 00 eps $1.25
Merrill says " Our expert believes this will have no impact on the usage of Rituxan at all ... We think IDPH shares will trade off on this news and we WOULD PURCHASE THE SHARES, PARTICULARLY ON ANY WEAKNESS."
It was good to get info on "reason" for sell off. Thanks. The timing seemed right to buy more so I did just that. An overreaction to "bad news" provided another entry below 30. And the upgrade is a nice bonus.
If you folks learn what is presented at these conferences and post info that will be much appreciated.