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That's too bad, but could you tell us who is the moderator now, so we know whether we want to continue reading and posting here? Thanks.
Panel opinion on satraplatin at least shows ODAC consistency...
consistent in moving back the goalposts even after the ball has left the ground. Perhaps their rejection of Provenge is forcing them to hold to a hard line on satraplatin, or has managed to scare reasonable compassionate doctors into hoeing a statistical hard line. At least DNDN is not alone. Perhaps this will motivate biotech CEOs to back a lobbying effort with real staying power, like PhRMA does for big pharma. At this moment the biggest threat to them is the FDA, not each other. Genentech is an exception; not only are they secure for now with their approved drugs, but they will always have a shelter waiting for them in the wings of corporate parent Roche if the FDA storm comes their way.
Expression outside prostate was shown only in mice not human, and it has already been shown that mouse PAP has wider tissue distribution (http://www.asco.org/portal/site/ASCO/menuitem.34d60f5624ba07fd506fe310ee37a01d/?vgnextoid=76f8201eb6....
If you read the paper you will see the only evidence they present of PAP outside prostate is in RT-PCR of mouse tissues. There is no second experiment (e.g. by Westerns or Northerns), and no examination of distributions in humans. Also vital information is missing (namely primers used for RT-PCR expression analysis, supposedly in a missing supplementary file that is nowhere to be seen). Overall a rather sloppy hasty effort, not what you would expect from Cancer Research. What is the rush to publish this? Why did the editors not say, more evidence needed, "approvable?"
If you find humans a better model for, um, humans, Cunha et al examined expression of PAP, PSMA, and PSA in human tissues and found PAP to be the most specific (http://linkinghub.elsevier.com/retrieve/pii/S030438350500501X).
Cunha et al. used primers from the EC region in both the secreted and this newly identified TM form of PAP, so it's not that the Cunha primers would have missed the TM form. OTOH they also only did RT-PCR.
Also I did a quick search of human ests and there are no clones of the form predicted in this new paper. This is something the reviewers should have asked for. It could exist, just be in very low abundance. There are mouse ests of TM-PAP though, so it could very well be that this is the form that is widely distributed in the mouse.
Oh great IMPACT enrollment might be completed this year. What is that, 10 patients a month? I hope the company's clinical trials coordinators aren't overexerting themselves. I wouldn't want them to pull a muscle and put themselves out of action, considering how difficult a job it must be.
gofishmarko thanks for the ref EOM
I have a theory for Small's silence. I think it may have to do with his trials on GM-CSF and MDX-010 (ipilimumab) for HRPC. See 2007 ASCO abstracts 49 and 4609. It being a holiday, I am feeling too lazy to go back through DNDN's results to see how Provenge compares with his observations of 3/24 patients showing 50% reductions in PSA (fairly consistent across three protocols using ipilimumab alone, or in combination with GM-CSF, or in combination with Taxotere).
Clearly this is a future competitive threat to DNDN, IF it turns out that general immune stimulation is sufficient to give a similar long-term clinical response. It's a big if, but it would be another way to explain why there is no immune response against native PAP, as you point out. That is, the explanation is that no such response is necessary; the infusion of GM-CSF-stimulated DCs is enough to stimulate the appropriate T cells. And if that were the case, injections of ipilimumab with or without GM-CSF would be an easier way to achieve that.
So Small's silence might reflect some distance growing between him and DNDN. He clearly has his hands full with various trials, and he now needs to maintain relationships with other companies such as MEDX, so he may be unable or unwilling to spend extra time or go out on a limb for Provenge.
Anyway, a happy July 4th to you, too, rancherho.
Re: "I still can not understand why DNDN did not price a secondary right after the panel meeting. It just does not make any sense whatsoever unless there was a conflict between them doing that and Gold selling his shares..."
I thought about that too, but I think the right explanation may be the easiest one... that the company really was expecting approval and got greedy. Why sell a secondary at $15 when they could wait a month for $30? I am sure the shareholders would have screamed bloody murder if the company had gone ahead with a secondary between AC and PDUFA. It may have been the one time the management thought like shareholders, and ironically it did them no good.
At least it shows the management are just as bad at investing as I.
Yes baffling price action. Best hypothesis is engineered short-squeeze by long hedge holders, aka pump and dump. Move it enough in the premarket to create a positive spin, assure multiple positive news articles, scare weak shorts. It's a real surprise after many years of seeing the opposite thing with this stock. First time for everything, I suppose.
PM walldiver on investorvillage.com
For that matter PM me there; I have news you can use.
Supporting data from different disease stage was allowed per the old guidelines too: see page 9 of http://www.fda.gov/CDER/GUIDANCE/1397fnl.pdf
The new guidelines certainly leave the agency a lot of wiggle room. "Demonstration of a statistically significant improvement in overall survival can be considered to be clinically significant if the toxicity profile is acceptable, and has often supported new drug approval."? That should be "should be considered" and "should support new drug approval."
I didn't say the industry was bland.
The blandness could refer to drug names, marketing, and R&D activities, since they're generic by definition, low-key, and virtually nonexistent, respectively!
Anyway I was just trying to help you out with a funny name. If you've got a better one, why don't you suggest it.
You're welcome.
Big bland pharma
OR
Bland-name pharma
REGN is, what, 4 years behind in the AMD market?
REGN needs to do phase I and II trials.
If VEGF-trap is is more potent than Lucentis and Avastin, there is more risk for side effects. If there is a non-trivial side effect that is not present in Lucentis and Avastin, the VEGF-trap may be toast. Remember this is the very vulnerable geriatric patient population, and AMD is not a directly life-threatening disease.
If it is not more potent, they will have to compete against the already-established Lucentis and Avastin, and eventually generic versions of the above. (I know, not now, but later.)
REGN is lucky to get $75M now and maybe $110M later.
So the AMD market may be huge, depending on how you define huge. But REGN will most likely get a small slice, and may even get no piece at all depending on clinical results. So the REGN deal is a very poor comparison to a potential ex-US partnership for Provenge for AIPC+ADPC, together the most common solid tumor in men, a market that will grow as people live longer, and a market not addressed well by any current therapies.
Neither of the Zolinza trials were controlled! No blinding, no randomization, no comparison.
All right Dew, that's enough. I wasn't going to say anything, but now I have to, after that last snide comment which is an insult to all who use message boards to gather useful information for themselves, while making efficient use of their time so that they can hold on to a real job at the same time.
That last comment was:
"Not sure what you mean by this, but I’m watching the movement of the DNDN regulars from iHub to iVillage with amusement; it reinforces the notion that many DNDN posters don’t really want intelligent discussion. Rather, they want the pinball-style “action” that they were used to on Yahoo, replete with pumping, bashing, multiple aliases, and a recommendation counter."
Previously you had said:
"I’ve been reading and posting on internet message boards for almost as long as such boards been around. I’ve found that—excluding the nitwits and ne’er do wells—there are basically two kinds of posters: those who post for information and those who post for recommendations. The latter kind of poster will of course gravitate to an environment like Yahoo or iVillage."
My rejoinder: You left out the third kind of poster: he who posts to inflate his own ego while putting down others.
I would like to say a big thank you for moderating this board, and for posting the read-me-first primer. Still, maybe you should pop on over to investorvillage once in a while; many of us are over there and would benefit if you could stay informed in the discussion. It is the same as how you used to have to go over to the yahoo board. FYI investorvillage does not allow multiple aliases.
Another advantage of investorvillage is many other yahoo boards have migrated here too, much more than investorshub, where each board requires a moderator. Investorvillage as a site is much more a substitute for yahoo than investorshub for anyone who owns more than one stock.
You may want to check out investorvillage, too. Many of us, including radoncdoc, are over there. It shows number of recs like Yahoo, but also allows you to see who recommended what. It allows very long subject lines, and you have the ability to add custom links to the top of the page. I've added investorshub as a link so I can pop over here quickly.
Some are afraid investorvillage, being unmoderated, will pick up bashers, too. However, I am predicting it will be a far smaller problem than Yahoo was, because it does not allow multiple aliases per registered email. So a basher who wants 10 aliases will need to sign up for 10 email IDs around the web. We'll see how it turns out.
Let's all move to investorvillage!
Let's do it! It's no trouble yet for the few of us here to move over, like you and I did.
Also, thanks for your reply about DNDN being on someone's "avoid" list. You wrote out the facts and numbers behind my assessment that avoiding is the complete opposite of what one should do with DNDN at this moment.
Another DNDN board at investorvillage
investorvillage.com is more like the old yahoo format, simple listing with recs.
Re: Dew, why don't you just say
>Except in rare cases (e.g. where I’m trying to accumulate a thinly-traded stock), I’m up-front about my positions as well as my actual trades, which I generally post on the Biotech Values board in real time. For instance, I’ve posted all of my short and cover trades for the six biotech stocks I’ve shorted in 2006 (AGN ALKS ASPM OSIP TELK VRTX).
If you look at my iHub profile page, it shows what positions I have, what I’m following but don’t own, and what I’m avoiding. DNDN is currently on my avoid list.<
Thanks for the reply. You are entitled to put anything you want on your avoid list, of course, but you have only 3 stocks on your avoid list, and there is no way DNDN at current prices is one of the 3 worst deals in biotech. I would say it is one of the BEST 3 deals in biotech, actually. So there are 3 possibilities to explain this contradiction: 1) you really believe it to be one of the 3 worst deals, 2) you think it's risky, and your avoid list is a rather arbitrary and limited selection out of the entire biotech universe, or 3) you have an interest in keeping DNDN price low.
If it's #1, we just have an honest disagreement, which is fine with me. My background is in molecular biology and medicine, and I have taken the time to find out all relevant info on DNDN and its competitors, and I am comfortable with my investment.
Dew, why don't you just say you are accumulating Dendreon now, rather than just quietly posting little positive tidbits, like these graphs or the news of the FDA promoting adaptive trials.
Well, I'm being a bit presumptuous for fun. I did notice you are still arguing that the clinical portion of the BLA should have been filed by now, even though that starts a 6-month clock by which all portions of the BLA including manufacturing has to be submitted. So I must admit I am a bit baffled.
Given your heavy presence on this board, it would be courteous if you would reveal what actions you are taking on DNDN currently. I will say I am holding, and would accumulate more if I had spare cash, but are satisfied with the size of my holdings at the moment.
Good point, Dew, on why Yahoo changed formats. Only something like what you said could possibly make sense. Yahoo finance is the top finance spot on the web BECAUSE of the message boards (and the ability to track your portfolio), so their decision to make the boards less useful is going to result in a mass exodus, of which we are a part, reducing their popularity and hence their advertising revenue. It would have been smarter for them to, say, force people to see an ad each time they want to post. The additional advertising revenue could have paid for their ongoing storage requirements, and it would have made life harder for the spammers and non-stop bashers.
I really like ihubs restrictions on posting and the ability to edit posts. Hopefully that will increase the quality while decreasing the quantity of posts. Now if investorshub had a way of recommending or rating posts, then it would have everything Yahoo had, and more.