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What is telbivudine worth?
The present market cap seams a little out-of-whack here. I admit I'm a newbie and not yet up to speed, but it seams that the value of telb. + cash alone (w/o pipeline) would justify a higher cap.
So am I on drugs on this, or is this a bit of an overreaction by the market?
Well, CLSC did report N.
I know the trial failed, but they might have found some remotely positive number to put in a PR after sieveing the unblinded data for 3 months.
Even the actuall placebo numbers (so one could decide if the explanation was BS or not) would have been usefull.
Perhapse the trial failed somewhat worse than the PR lets on?
Swazie, nice find.
Nothing GTCB management can do about this type sh***.
At least it's good to see the SEC finally going to court on this type stuff. Too bad Deephaven and Lieberman will probably end up with a wrist slap and not jail time.
Selection bias in manufacturing.
Suppose we have a plant that makes 10mm ball bearings, but for whatever reasons they actually pop out of the machine at either 10.2mm or 9.8mm. Since we can't use the small ones, we sort these through a machine to discard those under 10mm, but this sorter is acurate to within +- .3mm (no bias in +/-). As we do this we record the measured size (from the sorter).
Now, take some of these bearings and measure them very precisly. They will be smaller, on average, than the measured size (since the impropoerly included bearings are all smaller than recorded, and the improperly excluded were all larger than recorded). This is straight math here without any placebos, trial size, of whatever.
It's really hard to argue against Dew's point that this bias exists. How significant in the case of Prov. is a much more difficult question.
On the 2nd CRO and blown data.
Generally, when a company announces the data has issues and needs to be examined more closely it just means the trial failed and they are trying to mine it for some hopefull data to justify continuing on.
But this story is starting to sound a little like the might really have screwed up the data, unbelievably enough.
An important point is that if the data is wrong, it can not be repaired after unblinding. The reason is that bias can slip in any only find issues that favour the trial arm. Thus, the FDA will not accept fixing the data.
But in at least one case I have seen a company solve this problem. Take the raw data before the problem occurs and give it to a new CRO to analyse without letting them know what the first CRO did (and of course, having them clean and lock the data before before re-unblinding). Does raise some eyebrows, but has a slight chance.
If this was just the typical "trial failed due to mild allergy season" type crap there would be no logic in all of getting a second CRO. Additionally, a second full analysis of the raw data would explain the blinded vs unblinded oddity that Beachgal brought up, the problem was found in unblinded data but the new CRO is working blinded.
IF this really is the case, then the new CRO would need a few months to through the cleaning/locking/unblinding/analysis cycle.
Maybe it really would be a good time to save money on the electric bill and have everybody take a long summer vacation
Q., playing p3 trial data timeline.
If we have a trial that has announced completion with results due at ..., how does playing a timespread on late vs. early results work?
Interrum odds?
Seams like they are a longshot almost by definition.
How many cases do we know of when one has hit?
pgs, I rarely like legal actions,
But I agree with you that it looks like TELK may be past typical boosterism and at borderline criminal negligence.
The '3 bagger' issue struck me when the story first hit. What a surprise the first 2 trials were horrid results.
Telcyta, the new placebo!
Woudn't all the dndn tin foil hats jump on that
DolphinM, it's now about software.
The data processing aspects of this type stuff are trivial. The issues will be from the human side of gathering and interpreting the raw data to generate the numbers that need be processed. In this case, doctors have to read diarries and decide the level of the patients reactions. There are many places for errors to occur before you have a nice, clean, locked dataset to be analysed.
You are correct though in that once you have this pristene data, you should be able to unblind and annalyse w/o difficulty.
What should be clear is that the problem (if it exists) had to occure before locking and unblinding, else if would easily have been fixed. It just can't take that long.
"so its better off being at one place, being respectable keeping the foul up quiet so both parties can try to figure this mess out."
But, the labs that screwed it up have seen the unbinded data, and therefore any "figure out the mess" performed by them that goes back to raw data will carry no weight with the FDA.
So where does that leave them?
The best hope is that only one trial was tainted. If so they go for a single trial aproval with supportative data from the screwed up trial and the earlier P3. The FDA allows more leaway in supportive data than in pivital trials, so here they might get away with explaining a screwup.
The only other chance I see (if the raw data really indicated efficacy, but was screwed up in collection/entry) is to get a new unblinded analysis done. To do this, you would have to go with another indpendent lab, else the FDA would really raise an eyebrow.
Do you guys know what "locked" means?
In trials you "lock" the data after it has all been collected and verified before unblinding. The concept is that it is not acceptable to look for and fix errors after unblinding because there might be a bias in what errors you find, or how you decide it's an error.
What does this mean? If the numbers were not stat sig because of errors, IT'S TOO LATE TO FIX THE ERRORS FOR SUBMISSION TO THE FDA.
There is a remote chance they could pick another indepenedent CRO to analysis the raw data (blinded), verify, lock, unblind and redo the analysis. Perhapse the FDA would accept this if there was clear proof that the first group screwed up bad.
It seams highly unlikely that the (possibly errant) data is stat sig, or the company would just have released that news and dribbled the rest out later.
"If one trial has good results and the other doesn't, that's bad"
If one trial hits stat sig and the other is a narrow miss (say p<.07 or so) then they probably will file and take their chances.
There was a thread related to this on the biotech values board, and nobody found a recent example for a non life threatening indication that garnered aproveal. But it was pointed out that there may well have been no candidates with this situation, so who knows.
If not selling stock, why pay for PR?
Road shows for small developemental bio's are for the purpose of getting financing. If they arn't looking for funds in the next 12 months, why waste time and cash on PR stunts?
Despite what some might think, there is no value in companies trying to improve PPS by advertising the stock, any effect will be short term and the market corrects back towards fair value.
Hopefully next year we will be close enough to US marketing that this type effort will be worthwhile based on establishing a corporate image, but this would be to assist sales of product, not stock.
And anyway, the immediate future for PPS looks very bright. Looking at the chart, I would think there is an excellent chance of a further 1-2 penny rise in the next month!
What does 'very well powered ' mean?
Most interums have no chance in hell to hit, so a 10 percent chance would be 'very well powered' in my book.
More importantly, subjective statements by CEOs are meaningless.
And yeah, what Clark said
1/3 is very optimistic.
I am one who believs in the efficacy of Provenge but seriously doubt the interum peek hits.
The slight unkowns always work aginst us here.
"Constant contact" may be basis for DNDN suit.
Gold used the phrase often, then he surprised the analysts at the post letter call when he stated the contact had ceased a few months back. I don't have enough details in my head to know if he said it after the contact would have ended, but it could swing a jury with a lie by ommision argument.
I don't think the stock sell was that relavent. How many posters here have argued that investors were insane to be long post AC, why on earth is it not reasonable for the CEO to diverisify out? I wasn't nearly as concentradted in DNDN as Gold was, and I sure as hell got much of my ass out of town post AC. Plus, this information was public before the letter, so investors could have acted on it.
Regardless, I think this, and virtually all similar lawsuits, are without basis. Just a huge burden on society to make lawyers rich.
When I get my check for $15 2 years from now I will gladly donate it to anybody running for office on a judicial reform platform.
"Gold: We have had some preliminary discussions with the FDA since the CR letter. Let me just reiterate that we know that current ongoing study, the IMPACT study, is a binding agreement, looking at survival. There’s an interim analysis there and a final analysis. Based on some preliminary discussions that we’ve had with the FDA there may be some alternative pathways outside of the 9902b IMPACT SPA, and those are things that we’re going to discuss with the FDA. What we know is that we do have an SPA for 9902b looking at survival on both an interim and final analysis basis and we’ll get the interim basis next year. "
That sounds crystal clear to me. If another statement had some ambiguity, that doesn't counter a statement that removes it.
Unless Gold has outright lied, there is a specified interim.
I would wonder if they are trying to change the alpha allocation with the FDA, and that is why they are not telling us.
Where did 7% come from in NFLD NI trial.
The PR for NFLD said that the NI trial goal was to be within 7% of the blood arm. I assume this means that you take the placebo arm's OS point value + 7% and compare to the 95% CI of the PolyHeme arm.
So where did this 7% figure come from? You really don't have anything like large trial data on blood vs. saline or whatever, do you? Does the company just sit in a room with some FDA guys and use various studies to pick numbers out of? The variables in trauma situations are so extreme it's seams impossible to have a real NI margin.
Is the whole concept of a formal NI trial based on providing some fraction of the comparator's effect just BS here, and they (includling the FDA) are just making things up as they go?
Duplicate, sorry EOM.
Actually, there is very strong evidence that the FDA decision was NOT political.
First, if FDA management had planned on an aprovable and were acting politically, they certainly would not have allowed the question change at they AC meeting. Without this the story would never had gained traction in the media. Thus, they would not be being attacked for it with anything near the present zest.
Second, the political "easy" decision was to follow the AC vote for several reasons. Most importantly, 3 years is "forever".
To be honest, it was my belief that they would be somewhat political that led me to apply this logic post AC and incorrectly raise my odds of the FDA Ok'ing the efficacy data.
Oh well, live and learn.
>>You have not a shred of evidence of that..
Actually, there is very strong evidence that the FDA decision was NOT political.
First, if FDA management had planned on an aprovable and were acting politically, they certainly would not have allowed the question change at they AC meeting. Without this the story would never had gained traction in the media. Thus, they would not be being attacked for it with anything near the present zest.
Second, the political "easy" decision was to follow the AC vote for several reasons. Most importantly, 3 years is "forever".
To be honest, it was my belief that they would be somewhat political that led me to apply this logic post AC and incorrectly raise my odds of the FDA Ok'ing the efficacy data.
Oh well, live and learn.
Speaking of irrational DNDN longs.
Who is buying DNDN at over $7???
The stock traded under 5 all winter, add in the certain dillution comming up and it will be under $4 within months.
Are people really paying a 100% premium on the chance of some Senator getting riled about the FDA, or is this just a distorted market due to puts and shorts being settled?
Regardless, will just keep buying a few $5 puts across the calander and wait for the smoke to clear.
How many meta-studies has Dr Nissen performed?
Is it just these 2, or has he done dozens and only published the "hits"?
Red rice yeast and lovastatin.
The Chinease have used red rice yeast in food for centuries because they like the taste. It had also been claimed to be healthy for the heart (seams like all rare/unusal foods have such claims).
Well, turns out that it contained lovastatin. So the claims that it lowers cholosterol were reasonably well grounded. But as health food vendors started pushing this big time, the FDA stepped in and banned it (it is now back, after several court orders and theroetically processed to exclude the statin).
If I am not mistaken, statins as a class are the largest revenue drug.
Now, this is not a solid comparison to PreHist and B12, but there are similarities.
The importatnt point is that the FDA did act against a real food ingrediant (while cyaoncobalamin is NOT in any naturaly food).
Of course the FDA will continue to allow vitamin pills containing B12 in the cyano- form, but any hint of advertising high dose orally absorbed cyancobalim for preventing hey fevors will get their ire up.
PI, why this is a minor issue.
Yes, people are selling B12 in the form of an oral lozenger release of cyanocobalamin. And yes, it's assumed one could take this. BUT...
1) Cobalt could go after a company that advertises it for this use.
2) Only Cobalt could claim it's FDA aproved for prevention of allergy reactions (probably the most important point).
3) It's quite possible that Cobalt could pressure the FDA to clamp down on these suppliers, because cyancobalamin absorded through the blood creates circulating cyanocobalamin that would not exists naturally, and therefore is not legitemately a natural supplement.
To elaborate on the third point, when taken as a standard vitamin B12, the cyanocobalamin is metablised into other forms of cobalamins that the body actually uses. It is also somewhat limited in that you can only absorb a few ugrams this way. The oral lozenger or similar approaches have the cyano- form itself in the system and also allow higher doeses.
All said, there will certainly be some of this (and you can forget any sales at all in the third world), but it's not a killer. The prescription drug NasCobalamin (or some such) is a nasal gel version of B12 that sales quite well despite the exact same issue.
B12 deficency status in the P3 trials?
Was this tested for and excluded in either the earlier P3 trial or the current 2? Also, was B12 serum concentration a stratification criteron?
Or even simpler, if somebody has a link to the trial designs?
TIA
It's financial insanity that so many Dendreonites..
Who knows what the vast majority did. I know that I am up $150k on this, and that's discounting my few remaining shares and leaps.
In case you guys miss the point, this was a $4 stock that is now at $7. Over the winter I heard Dew argue quite well the case against aproval, and never had a real issue with that. I personally had the odds somewhat better than him, but that's minor. What I did think was the stock had great upside to little downside. Well, we now have the "downside" and that turned out to be a 50% gain from where it was.
People arguing before the AC that approval was a lock were of course hopelessly optimistic (though after the AC, with Whitten/Gooden changing the question I thought it was very probably that the CMC issues would be all that could hurt). I'll ignore all the good/evil and conspiracy stuff.
If this was financial insanity, making over 100% profit, then I'll just keep doing it
Does PSA ever decline in AIPC?
I know it's just ancedotal, but from
http://www.drkoop.com/newsdetail/93/8015943.html
"Two years after receiving Provenge, doctors say the swelling in his lymph nodes and his PSA cancer markers are down."
I thought once PSA started rising after Hormone treatment fails it never comes back down?
If we're talking short, NRMX?
Seams like they just about announced that the Alzamed trial results will suck (they just unblinded and announced they will have to tweek the stats analysis plan over the next few weeks).
"Neurochem has been advised by its external team of statisticians that adjustment to the initial statistical model, as set out in the statistical plan, would be necessary to provide accurate results. "
Am I wrong about my interpretation here? And if not, how is this stock valued over $5?
Black-Scholes will not apply here.
The model assumes a normal distribution of the price of the underlying equity at time of option maturity.
I don't think we need a PhD in econ. to tell us that this is nowhere near the case for a developmental biotech approaching a "binary event".
As to using the actual pricing to determine what the market thinks, I agree with your numbers. The problem though is that you could run the same calculations 1 week ago and get a wildly different answer. Despite what the talking heads say, the market is fairly stupid when the instrument can not be analysied by financials.
Re: Quiz: What drug had an advisory-panel ..
Iressa just about had to be planned in advance, even if not formally called. The NDA was recieved Aug 5,2002 and the AC was Sep 24.
Blade, no way the pannel was that confused.
I will say though that I thought the whole process was a complete cluster-f****.
Dr Small misses his flight?
The FDA stat guy can't speak English?
The panal doesn't know the single most basic issue they are deciding?
You coudn't write this into a movie script w/o being laughed at.
Blade or Dew.
" I would have had her do exactly what Dew suggested: She should have framed the question in terms of "approval" vs. "approvable." That would have helped eliminate the ambiguity that now exists. "
What does that mean? A yes/no vote on "approve" was exactly a vote on "approve" vs. "approveable" since the third choice was clearly off the table. Changing this phrasing of the question doesn't change the substance at all.
Q: Why did LLY book $71.5M of 1Q07 Byetta revenue, rather than the $66.9M figure mentioned above?
With no knowledge of this deal I would gues in order:
1) Milestone payments being earned.
2) Byetta drugs used internally by ALMN (trials).
Alternatively, is the ALMN deal exclusive (or does somebody else have rights somewhare in the world).
>>This ODAC reference document goes back to 1993
Working my way backwards, out of the first 14 yes votes only 1 drug (UFT) was not approved.
Approvals were generally within 1-2 months. One drug (Bexxar) was delayed several months for more safety data that the company mentioned to the AC,. but had not previously supplied to the FDA.
The failed drug, UFT, was actually pulled by the company (Brystol Myers). The issue was some requested data concerning combination useage that the FDA had requested, but BMS supplied to late for the AC to review (so the FDA never even asked the AC about this concern). It was also the case that the SOC changed in the meantime, maybe this complicated the issue.
>sorry, i see no difference, do you?< - dew
The OP was referring to his previous post of DNDN's 9902a H/R survival curve. I guess he didn't want to post tha 9901 data.
No, David is clearly correct.
The AA program is very exact in it's definition, allowing AA based on a drug showing effect on a surragate that has not yet clearly shown to be of clinical benfit (but obviously is believed to be of benfit).
The exact question of "can a OS benifit with less supportative data qualify for AA" was actually asked of the FDA in it's public comments period on the AA process. The FDA said NO, period.
I don't dispute the logic of the argument you and a few others make, but it has no relavency to present FDA decision making.
It's also irrelavent to Prov, it clearly gets aproved despite somewhat skimpy supportative data.
Of course it's reasonable to sell.
As someone who has gone through a nasdaq IPO with quite a lot of shares, I did sell whenever I could. Anything else would have been retarded.
Dr. Golds finances are HIS finances. Why should he have to keep his entire retirement / estate in one stock just to make investors happy?
He still has about 250K of shares, that's not chichen sh**
One thing I would say though. All these exec. level option/stock bonuses should ALWAYS have a 5 year lockup. That would not only avoid this, but also insure the decision making is in the best long term interest of the shareholders (not just for a quick buck).
Eagly eye: wrong on reasonable.
For safety, the word resoanble makes complete sence in that a drug that can save (or extend) lives can have more serious side effects that a minor pain reliever. "Reasoanble" means weight the drug risk vs. benfit.
For efficicy there is no such concept. Under law, the FDA must determine that there is reason to believe the drug does something (good). The question here is how certain, not the degree. Those rub on ointments for teneder joints have must meet the same efficicy requirement as a life saving drug.
I do agree with you in summary though, the FDA acted absolutely correctly in correcting the wordings, nothing is certain in this area.
But tumor growth IS most likely slowed.
------------------------------------------------
You said, " how could a man survive longer if the tumor growth is not slowed"
-----------------------------------------------
The flaw in this argument (I realise it's not your argument) is that it presumes there is no TTP benifit to Prov.
But there almost certainly is a benfit. Yes, the trials missed stat sig on TTP, but they still indicate a probable improvement. To say there is none is either complete BS or utter ignorance. 9901 had a P value between .087 and .052 for TTP improvement. All other trials have trended favorably. I'll bet anybody $100,000 straight up that both 02B and P11 trend towards a slowdown in tumor growth.
It still pisses me off that this argument whent unchallenged at the AC meeting.
Question on the "question".
My understanding of events is it was the head of CBER who interrupted the efficicy vote to change the question to a somewhat more leanient wording.
The head of CBER is (in the words of G.W.bush) the "Decision maker" here.
If these facts are correct, isn't it clear what the decider has decided?
[Sorry if this is stale, but I have been incommunicato for a few days and have had a hard time following details]