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RE: preposterously low valuation.
No argument with you here. It's just that value plays happen over months and years, not hours and days.
I do kind of assume what we have is some buying post conference based on value and Jan effect, plus some day trader types jumping in.
If it holds the gains though Friday, then you get the IBD crowd comming in, and we might see that 5.62 number by Tue.
Truthfully, I really don't care. None of this will effect the stock price next year.
RE: what happens at 5.62
Just a wild guess, but I suspect he is talking about closing the gap from summer.
Regardless, this present bump seams a little much for a reaction to some pre-clinical data. Either we have day-traders gone crazy, or there really is a news leak. JMHO
Semi OT: E-Trade
I lost a pretty penny buying some ETFC shares on the dip in Dec.
They more than made up for it though. I planned to sell my IDIX in Dec for tax reasons (and buy it back in Jan). BUT, E-Trade wouldn't take the order via the net, so I sold something else instead.
I feal like the blind squirl and the acorn today
RE: "that ATryn ahould fare better"
NO, we definetly expect that rAT is AT.
The "better" aspect rAT is that you don't get hep. or such from it (and it might be easier/cheaper to get in quantity).
RE: "... Hillary actually has tear ducts."
Hum, does Guilliane have tear ducts
WRT VMWare, watch out. The software is well known and has been around awhile. A quality product, but as for the company the hype and valuation is absurd.
But how else "dew" you get the delta?
I thought the "big issue" with the FDA on NI trials was that you MUST establish that the drug has some effect. If the NI margin was such that a placebo has a good chance of passing, you have a real problem.
Therfore the delta (agreed to in FDA backrooms) must, in some way, be based on historical placebo (or SOC) data.
Let's take this trial as an example. If sDVT occurs at a rate of 30% w/o AT, then it's obvious that a NI delta of 10-15% is "reasonable". BUT if sDVT only occurs at a rate of 5%, then a NI delta over 3-4% is absurd.
I have no problem with your statement that the only thing that matters is what the sponsor and FDA agree on. I have 0 clue on that process vs. a SPA.
Re: 2 points.. Point 1
In any non-inferiority trial of A vs B the goal is to show that A is better than "half" of the B "treatment effect". How that exact value is defined seams to be very open.
So in ANY NI trial, we must pre-determine what the "half" value is. To do this, we MUST look at historical B vs placebo (or SOC). This sets the NI target for the trial to beat relative to B.
In this trial, it's somewhat confusing because the control arm itself is semi-historical, but this matters nadda.
The comparison in this trial is between rAT vs (AT arm + NIDelta), where the NI delta is something like historical (placebo-AT)/2.
Given that I assume the comparison arm will come out at near 0, the biggest variable in the goal will be the NI Delta, which will be based on the historical rate of symptomatic DVT.
WRT the lack of a SPA, I have a serious question.
Would GTCB have discussed the NI delta with the FDA before hand?
If not, then a "close call" trial result would be a serious issue.
[I assume the efficacy data will come in very sound, and this is all irrelavent]
RE: GTCB is trying to show non-inferiority...
"What we need to know is what percentage of HD patients given plasma derived ATIII had a symptomatic DVT. From the European trial of rATIII, we already know that zero patients out of 14 HD patients had a symptomatic DVT."
No, we can be fairly certain that the rate with plasma AT is near 0. But to get the inferiority delta you need to know what the rate with and w/o AT is historically (and then guess the SPA negotiated value).
For example. Suppose AT historically had 2% symptomatic DVT cases, and placebo comes in with 20%. Then the FDA would say that in order to meet the NI goal, rAT would have to be stat sig better than the comparison AT arm plus something like 10%. Thus, (wrt efficousy) the comparison arm data actually has very little effect on the actual outcome! What is much more important is the historical rate for non AT treated patients.
[OK, I pulled 10% out of my ass. It would be something less than 18% in this example, but given the already sketchy trial I doubt they FDA would be overly generous here].
RE : "however, I do have a problem with the token insider purchases"
I agree 100% (if not more, despite the math logic).
The delay is an absolute non-issue once the company stated that it was a 1 month enrollment delay.
On the insider purchases, I HATE token purchases by management. These guys have plenty of options to get rich on if it all goes well, why buy a few thousand shares?
I have no idea on the motivation here, but I have seen token purchases used as part of a pure stock scam (OT: see REFR).
What would have supported he stock price much more effectively at EOY would have been a simple announcement about the enrollment delay in mid Dec.
Regardless, it matters little compared to getting the job done.
Glad to here it was a delay in enrollment.
A few patients waiting until after the holidays for surgery is much better than a delay in "analysis" or the data.
.. you can patent just about anything ..
Yes, that's the problem.
One of my favorite patents was in the Y2k comedy. Sombody patented the concept that 2 digit dates less than (for example) 20 would be 20xx, but greater than 20 would be 19xx. Brilliant. Nobody was ever doing simple stuff like that.
And we of course have the AMZN "one click" patent.
Maybe I will write a patent for "Obtaining bogus Nigeran patents in order to extort cash from international companies".
Sorry for venting, but in my previous job I was point man for evaluating patent issues, and the state of the system is pathetic.
The patent system is really, really broken. Both wrt obviousness and gimicks to patent discoveries (discoveries are not patentable).
GNVC data, it's still thin.
I'm not saying the data is bad, just that there is very little yet. I certainly agree that the 5 to 7 event ratio (with a 2-1 arm ratio) is encouraging.
My statement about a single patient was quite true wrt median survival. The median survival of 19.1 drops to about 11.5 months if the last event had occurred at about 12 months. I know that's unfair to do, but it does demonstrate how easy it is for small N to be all over the place.
BTW, on the 42% OS, I assumed we were talking the HR, since the 12 month OS is now off the table. Obviously the KM does show this 42% at 12 months, but it is also 0 at 10 months; so I wouldn't assume you are seeing an OS HR of 40%.
IHUB has their blue and green reversed.
That's my story, and I'm sticking to it.
"there doesn’t seem to be enough green to signify volume inside the bid-ask."
I would expect very little volume inside the current bid ask at transaction time.
Actually, in the "simple" theory of how it all works, there is no volume there.
Also, volume on bid vs ask is a very reasonable graphic.
GNVC, a few questions.
1) How did they get away with changing the trial primamry after having unblinded about 1/6 of the patients? Would the FDA re-run the data w/o these events?
2) If I can count tics, the early unblinding after the 51'st patient was treated had 15 events. [Correction, it is 12 events] Not all that significant (OS HR was p=.15).
3) Where does the 42% OS gain come from? It's not on the poster for this data:
http://www.genvec.com/download/ASCO%202007%20Poster%20Handout%20FINAL%20OUT.pdf
They do show a nice median OS benifit, but most of that benifit is driven by a single patient.
Anyway, best of luck here. Just don't bet the farm on the N=92 interim data
b) This bit bothers me:
"At the end of the study, nearly half of those taking testosterone exhibited the collection of symptoms known as metabolic syndrome -- a fat midsection and other conditions that can lead to heart disease and diabetes. However the difference in metabolic syndrome rates between testosterone takers and placebo takers was not considered statistically significant."
This paragraph stinks of BS science to me. They state one arm with no data on the other arm.
As a general rule, when ever somebody does this type stuff (be it some random paper writer or a company CMO) I assume they are hiding data that runs counter.
If somebody doesn't present the hard numbers that they have, then the numbers probably do not support their argument.
Regardless, the whole T replacement question wrt metabolic syndrom is worth more study.
Quiz: Truman's VP did run.
Didn't get the Dem. party nomination.
Election quiz.
No incumbant or VP running.
RE: Tax loss selling puzzle:
The effect is real, but 1/2 day on 3 stocks is just a tad short of a real sample size for verifcation.
Plenty of N=300 trials show efficicay, and your n=3 fails
WRT the INGN comedy
Who on earth is "Canacord Adams analyst Joeseph Pantginis" who has been on a bull on the stock through the entire (and ongoing) release of the mystery P3 data?
Hey, it's possible the drug actually works. But the P3 trials failed miserably, and for any analyst not to understand this is either due to gross incompetance or serious conflict-of-inteerst.
Well, if they don't let me chase..
Put in a little buy for 5K shares at .84, after a partial fill I tried to up it .85 to complete, but Banc of America Invest didn't take the change (a new account, I have no clue why).
So hell, I'll just sit there at .84 and wait.
At least if I don't get filled, the price has a floor
RE: "Since the current study does not have a placebo arm"
Yes and no. There is a comparator arm that GTCB would not know the results of (presumably). Thus, to some extent, to try and guess results from the active arm is still guessing the control arm goes as historical (less so, obviously, than the standard trial).
Q for Dew:
Why did the FDA accept this trial design? Because they believe that ATryn is effectively the same as plasma derived antthombin and, are therefore are mainly only looking for AEs?
" ..the FDA would allow them to pre-screen responders.."
In general, the FDA has no problem with the concept.
In this case you have issues though. First, I doubt there exists a way to screen w/o providing several rounds of treatment. This kind of invalidates the trial, yes?
Second, as has been pointed out, the evidence so far does not support the claim the drug works in the subgroup (just that there is a corrollation, which could very well be that the drug and IR identify survivor types). Thus, you would certainly have to go back to P2 tests and we are now well over 10 years out or so.
Maybe there is some magic data out there that escapes this trap, but you still have 6-7 years or so to run another trial.
Another one bites the dust.
"One measure of this is what is the p value for the non-responders vs control. If it is stat sig the wrong way then both subgroups are probably worthless."
A caller asked the company if the presented results implied that the non-responder group did worse than the control arm. The company replied "yes".
Was this a mistake? Did he mean "it trended worse" (as opposed to stat sig worse)? This would seam like a very sloppy reply by somebody like me, and absurdly sloppy for a biotech exec on a CC.
If not a mistake, it makes it quite likley that a least some portion of the treatment effect amongst responders is mearly a "detection of the healthy" effect.
There are definitely some bad numbers in the closet from the way the call disclosed almost nothing. I would not be surprised if this is it.
GTOP "Well, why don't you submit the placeboe"
An analyst actually asked this question, LMAO
I don't know who asked it, but the guy sounded intelligent enough that I think he was jerking the company's chain wrt the claim that the trial showed the control arm was active.
But, on another subject, we did learn how "cancer and the immune system are in balance". Much better than data
"GTOP – The higher PFS in the “responder” subset merely means that people with a strong immune system are in better shape medically than those with a weak immune system."
When questioned on this exact point, the company twit said he didn't understand the question. Then he said this was not the case because the data was against a control arm.
Either this guy is too clueless to have a job in this field, or he should be in jail.
GTOP, yes the CC is BS.
On the 15th question they finally pryed the primary endpoint P value out of the dude. P>.1
We still never heard the P value of the responder subset analyses, or much of any other numbers.
BTW, and WTF!
The company said in response to a certain questioner that they would give that information later in a private meeting. Perhapse the SEC should enforce reg FD when the company states publicly in a CC that they intend to ignore it.
GTOP trading.
I don't buy the "after hours" theory, becasue bad data could easily have been delayed into Christmas if the company wanted to play that game.
Maybe some traders who were playing the "buy 'till the runup then bail" and got caught, or maybe a leak.
We will know soon
There is SOME bad news in the PR.
This makes it very unlikely that antiThrombin can compete with Ampligen as a miracle cure for everything
INGN latest PR, straight from Comedy Central.
http://biz.yahoo.com/bw/071220/20071220005137.html?.v=1
In short, after data-mining their aborted P3 trial for a year, they decide they need more ore to shift through in the attempt to find gold.
The good news is that in 6 months we will here another excuse. I predict "The dog ate my homework" line
BACKGROUND: Before anybody foolishes wastes there time looking at this company (like I did), here's the Readers Digest summary. They have a drug that might be effective in cancers with a defective P53 gene. They ran a pivital trial, and it never enrolled (actually 2 trials, but the second one was abducted by UFO's). So eventually they just looked at the data and it obviously was a no go. So then they decided to do a subset analysis, which required them to get data they didn't think of in advance. Now they want to go back again to paients and get more data. Through this whole process they insist they have always been 6-12 months (or less) from a BLA submission.
"Where do you see MNTA in ..?"
Still on the NASDAQ
Seriously, I have no clue, nor do I care.
All I ever do is buy companies that I like. More so if nobody else likes them.
If you want a serious answer, I expect a slow recovery to $10 or so.
The chicken bones I tossed on the sidewalk said so
Sorry for the terminolgy issue wrt "busted".
I just meant any company that took a big hit on bad news.
Those companies that are busted by your definition are quite worthless, they will spend the cash and be gone.
Certainly was not placing MNTA in the trash bin catagory.
"So my previous fears ..."
I swear, at time I think Crou is the Mel Gibson character in Conspiracy Theory
MNTA, just recovering from insanity.
That's why I so like bottom fishing.
Serriously, is so much easier trying to buy "busted" biotechs. Not only is the bad news gone, but you have the chance the stock is overly depressed (as opposed to a flying biotech, where you pay a premium).
"If the DTRA happens, aren't they obligated to PR it within so many days? "
No, this is a common misunderstanding of regulation FD (sic).
The rule is that IF the company discloses the information to analyst/fund/banker types THEN they must publicly disclose withen a short timeframe.
As long as they don't let there favorite Wall Street boys know, they can keep quite.
BTW, regulation FD is a farce. The day or so they allow is plenty of time to rape the reatil guys.
A real regulation would be to require all such information to be transmitted via open internet channels. The company could thus disclose whatever they want to their favorite analysts, but eberybody would know real time.
But, the SEC has no interest in really addressing the leaked info issue.
Insider purchases wrt SEC.
News on trial results would not be a problem, because he would not have known the data at the time he bought. Nobody knows trial results before unblinding.
As to a partner, as long as the status was reasonably consistent with the public statements, that is fine.
Problems would be if he had already inked a great deal (or already had top line results in hand).
The amount of the buy doesn't matter. But in practice, the SEC would obviously not care about a minor purchase. The only recent case I remember of the SEC taking action on a buy was when Murdoch bought DowJones, and some guy from Asia bought a ton of calls before the news was out.
Re: Nice entry time after sell off.
NOT
Oh well, I just 2x'd at .72 and am done. I think it's time to shove this under the mattress.
Right there with you at exactly $1.
Probably make some more beer money trading them, but who knows? Perhaps some good news hits while I am long (don't see any bad news on the horizon).
PANC: Bev. results for 350mg group not impressive
Many hoped this group would do better than the 300mg group, and it didn't (though, perhaps only because of absorbtion or clearance issues since the serum level was lower for the 350 group)
Also, I think many are viewing a 1.0log10 viral reduction as kind of the "mark" to hit, and now Bev is not there.
I didn't here the CC, but it seams the company is going with the "it works well for some" story, which always raises a flag (and they had no need to do this, it was a N=10 trial after all).
Might be a buy under $1?
Time value of puts as P3 top line data awaits.
I have sold quite a few GTOP Dec puts over the last month. Not because I think they will have good results on their upcomming trial data, but because I think the results can't come out that early (and if negative, they will wait till at least the holidays).
So here's the general question. Is it virtually certain that for small biotechs top line P3 data will be delayed for at least a few weeks if it is bad? Is this a playable effect?