With stock priced for expectation of 0.77 loss and $128 million revenue, will be interesting to see how strong the move up in response to these outstanding results. 100 to 105 remains a ceiling based on markets long term anticipation of P/E. based on slam dunk approvals, but given one of the most productive records in biotech, that is pretty naïve thinking.
Well that sucks - 45K in short-term cap gain. At least the large majority of my profit was long-term.
I have a few hundred that will convert to long-term on that date.
You can find me if you look up who discovered the similarilty of the Hsp fold to actin. Hence my peripheral interest in Hsp rx. But now I do mostly clinical research. I just putter in stocks like others play puzzles. - it really is too easy when you know your stuff.
a look at these data gives me a lot of confidence in the phase III study. First, in GALAXY-1 the OS for all adenoca pts with Cox regression has p 0.04 with 90% CI .55 to .98. That is excellent for a phase II study that was not powered, as should be the case, to achieve statistical signicance. Secondly I think the data are poorly presented visually since the OS is the key parameter - they should at least have a bold vertical line on the Kaplan Meier curves showing the quite large differences. They do need some lessons in how to promote their data. Frankly, the thing that concerns me most is the selection of a subgroup with better prognosis for phase III, even though that makes some sense based on the available data. Wish they wouid have stuck to their guns. Hey, overexpression of Hsp90 is linked to poor prognosis. Based on the science, the poor prognosis patients are their ideal target population. Plus the failure to rely on primary outcome measures always raises suspicion, and in this case, resulted in a unreasonable negative response to the data. I made a big initial investment today and will buy more if the opportunity arises. I should mention that I'm nearly always right - I would have made a fortune in the market if I didn't find this stuff so boring.
Not irrational. just more cavalier than I. I never gave vioxx to a patient with high cardiovascular risk. I didn't wait for Merck to tell me this was stupid. I wouldn't give this vaccine to the 30% of the population with some autoimmune diathesis/genetic predispostion, and probably not to the other 70% for whom I am unsure. Should the FDA do the right thing? of course.
exactly. its complicated. its like tnf-antagonists provoking autoimmunity via downregulation of Tregs. who would have guessed? more safety data are needed.
GSK uses propietary AS0* adjuvants. Like others, it has risks. US let it get tested "in the field" in Europe and elsewhere first, so now the FDA can say yeah it's probably safe.
DVAX circumvented a major hurdle by targeting an immune response that was previously known to be protective; that way they only needed to show an immune response, not that there was any actual efficacy related to prevention of clinical infections. Your proposal loses that advantage. What made this drug novel was the adjuvant. Adjuvants are in general, scary things to immunologists. They are not even allowed to use traditional ones in animal studies anymore (look up Freunds adjuvant). Frankly I am shocked that this vaccine progressed this far before someone said this was ridiculous. TLR9; are you crazy?? This vaccine may convert every patient with subclinical SLE to overt SLE, maybe only after several years.
It was a bit of a crazy idea to use TLR9-based adjuvant. As is well known: TLR9 drives the development of transitional B cells towards the marginal zone pathway and promotes autoimmunity. J Autoimmun. 2012 Sep. On the good side, autoantibodies were not increased. On the other hand, clearly, the development of autoimmune disease in one in 5K recipients would be unacceptable. A study of roughly 30K sample size would be necessary to rule out this possibility. Instead, only ~5K pts were studied in phIII trials, which is why the panel says that they don't know if the drug is safe. Fair enough. As an expert in the field, I tend to side with the panel that I would not rec approval in this instance of a previously-met need without more safety information.
Data are probably a little better than most expected. These are basically the same data as previously released July 2010 from the 003-A1 study: "(partial response or greater) of 24 percent and a median duration of response of 7.4" and "(minimal response or greater) in the study population was 36 percent."
I think that the only thing new is that we now know that those with a good response are continuing to live and the overall survival for those patients gets better the longer the study continues: "the Overall survival for the best responding patients (partial response or greater) is continuing to mature (subject to additional patient observations) and is currently 20.7 months"
Its basically all good news: there were no surprises in adverse events after more long term follow-up, which I would say is the biggest worry, and there was no "regression to the mean" as they added the last responder data, and the long term survival is outstanding in the responders.
I think yesterday's drop was more sell on the news for breast ca than a response to the pretty much already known head-to-head results for Pfizer & RCC.
Thanks. Yes, at 24 minutes. "We are approaching the June trial date and are confident... Last week at a summary judgement hearing, the judge indicated that she would issue an order denying Bayer's motion for a summary judgement..."
yahoo won't post the link, but there is a video "Update from IMW 2011: Proteasome Inhibitors
Dr. Kenneth Anderson 13th International Myeloma Workshop" on the International Myeloma Found. website. Very positive overall, but not much specific to Carfilzomib. The mention of prior data (17% resp in R&R)and the quiet from Onyx suggests they had little new to reveal at this time.
Gleevec seems to be tolerate extremely poorly in at least one application outside of CML - scleroderma. A 2009 study in which 0 pts of 10 could take the drug even after dose adjustment stopped this rx application dead in its tracks.
you got to be kidding. its not rocket science. if and when y shares are offered, the x prior total shares will be diluted to x/(x+y) and if nothing else factors in (e.g. dilution for some good, unforseen opportunity), your shares are now worth this fractional amount of prior value. And not a good time to do it?!?! cripes stock is up more than 50% in one month. It's a great time - your company will get 56% more dollars for issuing y shares than it would have a month ago.