As everyone knows, the survival data OGXI has previously announced for the P2 randomized trial was as of November 2008, and tomorrow OGXI will update it through April 2009. I think it's important to note that the trial, which enrolled only 82 patients, wasn't powered to show statistical significance. Nevertheless, the survival advantage as of 11/08 was so large -- 27.5 months vs. 16.9 months -- that it reached or almost reached significance depending on how you look at it. P was .07, which was a near-miss, but when you account for the health status of the two groups P was .04.
It's likely that the median survival of the OGX-011 group that's announced tomorrow will change from what it was in November. How it changes will depend on how many of the patients who were alive but in the study less than 27.5 months in November survived beyond the 27.5-month mark. I think it's likely that the median will decline a little, simply because the difference between the two groups was so great. However, OGXI announced in its original PR in December that the median cannot decline to less than 22.7 months, which is still a hefty advantage over 16.9 months.
Nevertheless, if the OGX-011 group's median survival declines even slightly, the trial will fail to achieve statistical significance, and I suspect the bashers will have a field day with this over the weekend. In reality, that failure will be meaningless. The planned P3 survival trial will enroll around 700 patients, and if OGXI merely comes within shouting distance of the advantage it achieved with 82 patients, it will easily achieve statistical significance.
I thought it useful to make that point before the results are announced and, if the results fall a bit short, the bashfest begins.
I agree JBOG. Now that the company is changing the 700-pt 2nd-line study to a 800-pt fist line study, it's not clear what the regulatory pathway for the small second-line pain palliation study. My guess is as follows:
a. OGXI will seek a single-trial approval strategy based on the first-line phase III trial alone. It enrolls 800 patients, 90% powered for a hazard ratio of 0.725, therefore, it uses an alpha of 0.01, which is acceptable to FDA to support a single-trial approval.
b. At a minimum, the 300-pt 2nd line trial will contribute to a pain indication on the label, which would be a huge marketing advantage. I would be pleasantly surprised if it can gain approval on its own in the absence of corroborating tumor response, PFS or survival benefit, but I doubt it's going to. Hope for more clarity on the second-line in the coming months.
docetaxel commanded close to 300 million on prostate cancer alone, and it will go off patent by the time ogx-011 makes it to the market.
If people willing to pay 300 million for less than 3-month or 21% risk reduction, how much should they pay for a 6.9-month or 39% risk reduction?
What about the potential of OGX-011 in NSCLC, or ovarian cancer? What about OGX-427? Last time I checked OGX is not the only one who is tackling heat shock protein.
You're probably right, I have no direct experience with the FDA. Who really knows how they think. The words surrogate marker will probably forever disappear. But sometimes they do surprise you. They approved a new drug just this year for gout that I thought was doomed. Thank you for your help and take care. t
Whereas the practicing onc's know the value of easing pain in the cancer setting, practically to obtain fda approvals soley on pain management would be next to impossible with the current route.
To obtain an pain management surrogate approval as an cancer drug would take 5 to 7 years at best. To obtain pain management as a normal drug would make more sense but then the pricing wouldn't make it worth it.
Their best path would be OS, and then prove the pain management for the oncs.
p.s. I would guess take the fda would love to cancel all the surrogates they created over the last ten years.
You're right about the way big pharma is Ino, but I think that was really that way more 5 years ago than it is today. Big pharma's back is really to the wall, and their pipelines dry. Per unit time and per employee biotech is more efficient at new discovery compared to big pharma and they know that now. The arrogance has generally been replaced with wanting to stay ahead of the competition, which makes sense anyway. t
What a great board today My Special Thank you to P3 & jetman.We are away from the weekday childran ( sic) who have no position, no intellect or knowledge either in trading or in the research work by this company. So here I give you what I see in trading and I know plenty. First I see no great shorting major buying when offers show up and they never show up in a down mkt. Low volume on all down days. No bids.I see plus tick bids above the last sale which are not hit. When size shows up on the offer it is taken. I had my own seat and book as a specialist on the amex for 25 years stks/optiions badge # 1006 and I have a profile on yahoo.I had BNE for 20 years and BKR. Bowne and company was founded in 1774 now on the NYSE after I sold my book.I ignore the bashers as they are fleas.
We have to remember that one huge plus is that Ogx's has great connections to run their trials in Canada.
Canada normally accrues trials very easy with its social medicine program.
Cetuximab, panitumumab and getinfib all few thru their Canadian trials.