Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
The evils of percent of percent.
I would be more concerned with a move from 70 to 65 than the 90 to 88 change.
I would also be MUCH more concerned why management always knew the orriginal interrum was probably hopeless, but maintained otherwise publicly.
"what the hell is the integrated hazard ratio"?
I think it came from Brown vs. Board of Education
Damn that Daylight Savings Time
Anybody check the I-Village board for DNDN? Should be interesting.
DNDN's statistical model changed when they got financing in the summer of '07
Before then the model was to take a moonshot on the interum working, else suffer major dillution while waiting. Now that they got more cash, the decided that hey could afford to wait for the final, so reduced the interum alpha.
None of this takes astute staticians to figure out. What's difficult is the tradeoffs involving how important results are in a particular time window.
This was a biz decision.
BTW, did the FDA tighten the screws on alpha any to make up for this game? We will never know.
RE: Injectafer safety issues
Somebody sharper (and with more time than me at this second) might dig deeper, but here's my understanding.
Injectafer is a method of treating anemia by iron suplementation (it doesn't reduce the bleeding). Whatever the safety concern is could not even concievable apply to Prolex.
Here's the ranscript, alas no nice briefeing materials.
http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4337t1-part2.pdf
Clark shot down that logic fairly hard over on the DNDN board.
The key is that the probability of success at the final has DECREASED.
The reason is this. The final look has less events. In THEORY this cancels the increased alpha. So the final should have the same chance of success.
But THEORY here uses a constant risk assumption. Not valid with Provenge. The Provenge curves show a late seperation. This means that late events help provenge more than early events.
Thus, in reality the power of the final has been reduced.
I really doubt you need to name names
Re: DNDN's SPA change IHUB response
Actually, there have been 3 replies to DNDN's SPA change while in trial (dewd on the values mb, and iwfal and myself on DNDN). All posts were negative.
I had the most neutral post, saying it was just money driven. Iwfal slammed the stat side along with mgmt while agreeing that the change was likely cash driven. Dew just said management is so f** that there is no point evaluating the change.
If somebody posts a positive, that would could start a debate. But you can't argue with nobody.
DNDN realized they were spending to much alpha on the interum, so they took it away and gave it to the final.
With the extra alpha in the final, they could reduce events w/o effecting power.
Then they push back the interum to give it more events (since it would have had no chance with the reduced alpha otherwise).
One might ask "What changed"?
My guess is that it was as much a financial "time to live" decision as a pure trial design issue. The only question I would have is if they shuld have just assigned no alpha to the interum (though maybe they effectively have done so).
BTW, I am not being particularly critical of RPRX (just questioning). And I do kind of follow dewo's view on the drug proper (I believe he is very honest wrt the value of a drug that delivers the clinical benifit Prol. is looking at).
I just sometimes get tired of the happy face stuff.
Sounds just like Tony Snow interviewing Bush.
How about some real questions?
Why 15 patients in the palceboe arms of the 4 trials, especially when you know many will drop out?
Why no SPA?
The FDA does not like companies to use higher dosages than have been shown effective. For anemmia, why is the 15mg dose not in the P3?
What are the endpoints? In particular the company states the trials are 2.5X bigger than the P2s. So, this implies a composite endpoint of both arms treatment arms, or a P reduction. If composite, isn't that a danger in the fibr. trial? If a P reduction, what?
I know all these issues were beaten to death, so no need to ask. Just present the softballs.
Doc has already made clear that there is no reason to discuss the trial size issue with management.
So why question him on this?
OK, what am I missing here?
The anemia study is up against a placeboe, which makes it virtually open lable because of amenorhia.
So you want to have somebody go around and monitor the patients and insure compliance?
Perhapse they can try and guess anemmia before arguing with the patient to stay in the trial?
Or perhapse they should look at the surveys and decide if the placeboe arm patients shoud stay in the trial?
And you guys see no issue here?
"Why wouldn't an increase in progression free survival result in an increase in time until death?"
The best answer is that there are cases where trials don't show the corrolation.
One easy guess is that the harm done by a particular chemo might be just as detrimental to survival as the increased tumor burden w/o the drug.
BTW, I do see the orriginal point of the quote that many patients will misunderstand PFS. But I hope they don't start "dumbing it down" so much that an intelligent patient doesn't get accurate information.
That would be 16 types for most of us.
How do you bet on aTryn?
If you mean GTCB, that is a riskier proposition at this moment.
SPPI just got Levolucovorin approved.
Or whatever the name-de-jur is.
They are trying to claim a 200MM/y potential, but that sounds high. But for a company with an enterprise value under $20m, this could really help.
http://biz.yahoo.com/bw/080219/20080219005663.html?.v=1
Wouldn't the only one to have written a backgammon book be the obvious guess?
[And that ignores the clue that DewD told us some questions he asked]
RE: Outright manipulation
My post was in jest.
Outright manipulation.
There is no doubt that Nerf (and perhapse some friends like DocB) posted bogus trades amongst themselves in oreder to get a green close so Nerf could win his bet.
"support, but that is not to us to decide."
Alas, I think that it is a major failing of the present US corporate governance environment that it is truely not up the shareholders to select the BOD.
R/S news leak is no explanation.
The problem with that theory is that it is almost automatic for a company that drops under $1 to put the R/S issue up for vote. It is voted on as an option, so has no cost.
I do agree that if a company does a RS that makes it more liquid (for shorts) and causes a hard drop in price almost always.
Of course, the market is efficient so an R/S really has no effect
GTCB: Just for the record
What I was thinking was a partnership that included a highly dilutive financing aspect.
I really don't consider this likely, was just scratching my brain for an explanation other than the obvious answer of another poor financing deal leaked ( or scrapie, which I still don't buy).
No it's definitely not scrapie.
That could explain a minor drop. The price is now in free-fall.
I suspect either another pitifully done financing or partnership.
GTCB: scrapie makes no sence.
I saw that first post and discounted it. Way to easily to protect a small herd (in addition to your point that we have never seen it in humans).
BUT, enough people are clueless that it could be the driver of today's drop. Picked up a few more shares in case that is right.
Re: low key aquisition.
It's a very safe bet that when the headline doesn't even mention the name of the aquired company, it will not be one of the top 10 for the year.
OT: "You will have nothing constructve to say"
There is no way to avoid it, it is just a fact. Well, you could avoid it by running "pre P3" trials to confirm, but that is obviously absurd.
I think some are confusing this point with companies that clearly manipulate the press on trials, and the pushback on that.
Can we say GPCB?
IO - Guilty as charged
Already editited the bogus post.
And yes, I did miss your point in item 5. It really is item 4b, continuing the theame that running trials to detect minor differences is highly questionable, while smaller trials that show a real clinical improvement are more valuable to patients (assuming enough safety data).
BTW, just plain old beer.
RE: reflecting on the DewD "program survival bias" BS
Let's try and understand this. It a fairly simple statistics point.
Let's say you manufactured widgets. The QA weighs them (with a margin of error, but fair) and rejects all that weigh less than 1 kilo. You bag the widgets and record the weight.
On average, the weight of a widget sold is less than the recorded weight (even though the scale was fair).
This is because some widgets that weighed more than 1k were falsely rejected (and these were all underweighs), while some that weigher under 1k got accepted (and these were all overweighed).
Thus, the final product has more overwighed widgets.
This is really just a straight stat argument. You can question how significant it is, but it is real.
3. Cost effects P3 trials.
Duh.
4. Clinical effect vs. stat sig
This is a point that David at BSR has been pounding the drums on. Running a 2000 patient trial to detect a microscopic improvement in some clinical condiction is just not impressive.
5. Bigger trials might be bad because safety issues could outweight benifit.
Sorry, unless I misunderstand you, you lost your mind on this one.
"gambling games are generally fairly trivial"
I am actually unaware of any gambling game that gives you a positive expectancy that is fairly trivial with the sole exception of counting at blackjack.
I doubt anybody on this board could play in a top level rubber bridge game with advantage (and I have played quite a bit at serious stakes).
Dew's backgammon, ditto.
You want to play 100-200 no-limit Texas Holdem against real players?
All of these have an element of skill that takes inate ability and experience to master.
I'm not at all certain that just seeing through the BS biotech stocks and going with value is anywhere near as hard.
I do agree with your point that it is harder to diversify out in the market. In retrospect, I think I missed the major thrust of you post with my quick response to your "fairly trivial" statement. You are correct in this regard.
"like playing high-stakes backgammon."
Understand your point, that both are skill with an element of risk vs. just luck.
But this is a meaningless distinction, because I am aware of no pure skill game that give the player and advantage (which was what I was comparing it to). There are many forms of gambling that are the same as backgammon.
Bridge/Gin/Poker/21(if counting)/Golf(if good on the #1 tee box)/CasinoGames(if you are the house).
My point is you always have to understand thatb there is real risk here. How many posters on all these boards think their stock is a near "lock"?
"Investing is not gambling ..."
I beg to differ.
It is true that betting into negative expectancy is different from a positive expectancy. But once you have a gambling situation with a positive expectancy the situation is almost identical to investing.
One of the big lessons learned well in the gambling world is risk of ruin. You can have a clear advantage, and still go BK because a bad run hits you.
Same in the biotech world (clearly the highest risk in most investment positions). Even if you are good enough to pick stocks that are probably winners, you can't bet the farm on them because many will go BK.
The degree to which you invest vs. gamble/speculate is simply how what percentage of you bankroll you place relative to the volatility (SD for gambling) of the position (bet).
"want to raise taxes on capital gains too."
The problem here is that if one raises cap gains then you have an obvious reason for people to cash in on gains. So you have 1 year before the change with a big revenue increase, followed by a drop the next year.
And people scream "look, total cap gains tax revenue fell".
The easiest approach is to keep going as we are now. Once our debt get's completely unsustainable the dollar will drop 50% or so, and after our ecconomy goes into the toilet international cash will flow into to buy on the cheap.
Seriously, what is so tough with the concept that we need to get close to balancing out books? After the hugely criticised Bush Sr tax raise in 89? we continued on a path that balanced our budget with great economic gains. This was after the vaunted Regan tax cuts put us in a similar place we are in now.
After the Bush Jr tax cuts we are running a completely unsustainable debt and the ecoonomy growth is debt driven.
I am not saying higher taxes are good. I am saying we must get closer to a balanced budget, and it's hard to get there at a very low tax rate. Despite the fact that the US has one of the largest CORPORATE tax rates, overall taxes are very low.
"patients in the Davanat trial had a median survival of 6.7 months"
WOW!
I considered this possibility and didn't check into it because this is really past hype and into pure lies. It's not part of a sale or other commercial transaction, so you can't call fraud.
If I was the SEC though, I would call them on this one. The safe habour statement does not cover pure lies. And if they used extend to describe absolute trial survival, that is a LIE.
Of course, the pussy whipped SEC will never take action in such cases. Just like those two onc. biotechs saying their drug is approved for commercial use in Switzerland when they really have something like an IND and an inport/export license. Those 2 PR's were flagrant lies.
PRW: krenjp, I think you are to cynical even for the bar set by some small biotechs
It can not be a 7 patient subset, because they list 8 specific events.
Perhapse the largest "disingenous" remark is that patients had failed all other treatments, which was simply not true. Most would not have had the current SOC (Avastin).
" in more tax-friendly localities "
Not going to look this up right now, but I believe the US has the lowest tax rate amongst the devloped countries.
wrt the PR from PRW
1) They say the drug extended survival by x, but no mention what the comparison was against, or how they came up with it.
2) They compare SAE's to those in similar trials, ignoring you could well have more SAE's in trials of unaproved drugs (they did not compare to SOC trials here).
3) No p values. (understandle that it was not stat sig given the size, but they have said such).
I imagine Dew found several other points.
Sorry Dew, but you are wrong.
In Craig's statement he said "We can address the FDA concern in-vitro".
The recent claim was that "The FDA said we could address the concern in-vitro".
BIG differnece IMHO.
RE: Update on Survey of 2008 ...
So much for the "short the field" theory.
OT: "Any reason why they have to do a 3D graph for 2D data?"
Perhapse most marketing people have the IQ of a dead squirl?
Realy, I see various forms of this all over the place, and it pisses me off.
In this case the data is being presented to technical people, and you could be certain that the science guys on board would have drawn up clean graphics. But the marketing guys want PAZZAS.