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I didn't call INGN a scam, but it does quack.
It may very be well that their technology has real value, but they have been consistantly spinning PR while providing minimal real data that one must suspect the worst.
It may very well be true that a semi-retrospective analysise of the existing data will indicate a good chance that a P3 trial for ADVEXIN in p53 defective patients will be a great idea. BUT, at this point it seams beyond belief that INGN will even have enough data to get a NDA accepted (none the less approved) by the FDA.
The company could come clean. The could provide more hard numbers on top line trial results (patent secrets don't cut it).
They could have come clean on the enrollment issue in T301 and the other trial, but they haen't.
How long has it been since T301 was unblinded?
Do you really believe that they haven't been able to get firgures yet (and no PR???).
Sorry, there is no chance in hell the existing data supports and NDA. The company SHOULD come clean and state :
"We now realize that ADVEXIN works only in P53 defective cancers, and the exiting trials were not designed for this. Therefore we expect the need to start another P3 trial to provide the basis for an NDA"
But they don't.
Call it spin, call it PR material for stock selling. It still quacks like a duck.
Spinning another company?
Depends what your goals are. Yes, it would create a larger market cap because many biotech investors base decisions on a single pipeline drug, and barely consider others.
OTOH, if you want long term value the comapny should stay as it is. This will allow a quick monetary success of either drug to finance longer testing of the other.
Regardless, why are so many here concerned about stock price? If you believe the drugs can be brought to market, then just buy more on the dips and be happy
Conditions are different now wrt splits.
When I was a kid, you had to trade in 100s blocks or pay a huge commission. Therfore when stock prices went over $100 or so it put it out of reach of many common investors.
This is largly gone now (except with Berkshire Hathway class A shares), but some people still think that some stocks are "too expensive" based on share price alone.
Yes, stock splits today should have 0 effect, but they still do have some for irrational reasons.
On the other hand, liquidity issues are quite real. If a company trades $100k of shares a day, I certainly don't want to be $30k worth knowing I couldn't get in/out without a market penalty. But this issue is not effected by splits.
RE: INGN
OK, after going through this in a lot more detail I do realise that this comapany is an absolute disaster.
On the last CC they focused on some other companies related drug trial halt, saying how great it was that INGN's Advixin wasn't effected, and totally glossed over the fact that the P3 top line data isn't out well after it should be (presumably that is, because they never actually stated when/if unblinding of the final data happened).
I am stunned that this stock trades over $1.
Does anybone know why BSRDavid diss'd INGN's last PR?
http://biz.yahoo.com/bw/070927/20070927005160.html?.v=1
A few weeks agoe INGN released a PR that seamed positive. There ADVEXIN drug places the P53 gene into cancer cells, and analysis from P2 trials showed that the responders were only those who had cancers with P53 mutations. Logically, this seams like a positive.
I see from the history of INGN that they release a plethorea of BS PRs. "Our new drug showed benifits amongst left handed patients".
Is David just saying any INGN PR is BS, or does he (or anyone) have a specific point against ADVXIN?
I do see the possibility that the data might imply ADVEXIN works only in Li-Fraumeni Syndrom cancers, but I can't find nearly enough data on the actual trial results to know if this is his point.
(Traveling with limited net connectivity, so maybe I just can't search as well as I should)
I admit I sold half my position out, but I doubt that 10k shares was more than a blip.
Just an early tax loss sale, and I will buy back in one month with perhapse a more substantial position.
And if I screwed up and some great news occurs in the next 30 days, well I still am long 10k so that's fine.
And how do you spell confimation bias?
I think Due could have writen Adams' piece quite well.
"Three years ago, 24-sept-2004, "
So?
Sorry for anybody that lost money in the rundown, but that has 0 to do with the present value.
Let management focus on building the business. This stock will not trade on PR crap like most bios, so focus on reality.
Last I checked with God, I'm not planning on dying the next 2 years
'Why so long...'
Because they need to sign reinbursment agreements.with every country. This will be a rollng process with the larger markets first. I think the 12 to 18 month range is very normal for EU.
Andro will likely go through existing T marketers becasue they already have the sales force and contacts in place. I don't think I would call this a "concern" of their's, just a natural progression.
It is possible that the top tier pharmas are less interested in andro because the T market does have a somewhat murky side to it (though this is just speculation by me).
I am a little skeptical about a deal shortly following Oct. 15th though. I doubt the FDA puts too much in firm writing at this point. If I was buying the rights, I would probably want to wait a few more months for a signed SPA (and despite the SPPI/GTCB fiasco, a SPA still is a formal agreement by the FDA).
Regardless, I think you are correct that this can all play out before a financing would be in play, and I can wait a little longer.
Cheers
SPPI/GPCB Satraplatin OS results.
In GPC's FDA briefing document for the Straplatin AC meeting they have the interrum analysis K/M curves for survival on page 40. It doesn't look all that impressive, so they present a curve for the subset of patients followed for at least 1 year on the next page. They suggest/speculate that the data in the final analysis might look more like this "mature" subset data.
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4309b1-03-GPC.pdf
But this doesn't seam to hold up (even as a speculative argument). The problem is that the "mature" subset curves seperate quite well by 26 weeks, while the ITT curves have no seperation through 1 year.
First off, the ITT curve is "final" at about 26 weeks, so the set of patients excluded from the "mature" subgroup is clearly not doing well at the start.
Second, if the subgroup data accurately relects the total ITT, should not the curves be about the same despite the censored data points?
So is the difference chance or real?
If chance, then wouldn't the best guess of the final HR be 90% (the present HR for the overall group)? And if so doesn't that (probably) make the p value come in over the required .044?
If not chance, then things are even worse as Satra. is doing worse off in the data set that will be providing more data points as we go on (and furthmore, questions about the change in SOC come into play).
I do realise that anything can happen, it's just I don't buy the company line of looking at the "mature" subgroup.
If I'm really screwed up on these graphs I would love for somebody to tell me so (hopefully with a decent explanation)
Kind of no news for BIOM.
This is the follow-up of the same subset survival data in the PII study that led to the current PIII. Given that the median survival in the PII was much improved, this new data is not surprising.
It's still several years out before the excitement hits for BIOM.
But doesn't fast-track generally imply priority review?
My understanding was that if a drug was fast-tracted it would generally recieve a priority review. Exceptions being if the NDA was for a different indication (than the basis of the fast track designation), or an improvement in SOC makes the drug a "me too".
At N=50 (in the subgroup), the lack of stat sig. mortality is not surpising, but the overall DIC benifit looked promising.
Question, since ART-123 works on the APC pathway would this be expected to behave similarly to Xigris (recmbinant APC)?
Re: Death rate from prostate cancer
But has the DIAGNOSING rate for PC been steady over the timeframe that would have allowed for a stat survey (presumably retrospective) of an actuall cohort of patients?
To me it seams very believable if you looked at a sample of patients diagnosed with PC is 1970 (for example), you would find 30% died of PC. With a low level of screening, you obviously would have a much higher percentage of advanced cancers.
You really can't come much more recently than this for a sample period w/o having too many patients live through the study period.
So, David could be "right" in a formal kind of way, while the best guess for the "current" rate would be much lower.
RE: HIV testing before treatment w/ Baraclude
Wouldn't many MDs go a little further and avoid prescribing to those in high risk groups for HIV (assuming a reasonable comparable alternative)? I would assume that many HBV patients are in this catagory.
>> companies with interesting new technologies should not compound their risk by applying their technology to difficult or intractable targets
And perhapse that's exactly why GTCB choose not to lead with the DIC indication?
First establish ATryn as a valid biologic via the antithrombin hereditary deficiency trials, then expand to DIC; seams like the exact stratagy you would like
"I think this means 12-18 months from whenever reimbursement discussions began .."
I interpret the statement to mean 12-18 months as the time frame for completing all the individual reimbursement agreements, not for a particular country. Thus we would likely see individule countries sign on gradulally over this timespan (with hopefully larger markets comming earlier).
THRM, have they ever claimed to reduce fat?
From what I have read, THRM claims to "tighten collegen" and thereby improve the look/feel of skin. Have they ever made a claim the proceadure reduces fat somehow?
My guess on collegen is that they will claim it somehow breaks down the vertical structure that create the uneveness. The fat remains, but it would be nice and smooth.
And regardless of effectiveness, never unederestimate they market for this type crap
Quiz answer: PHRM has ex-US rights only.
As a follow-up question, I assume that PHRM has no intention of going before EMEA w/o the OS data. Does the EMEA even have an equivalent of accelerated aproveal?
SPPI: isovarin valuation.
Spectrum has the US and Canadian rights to isovarin, which presently has ex-US sales of $200m/year. So what's the US sales expected (asumming no FDA hitch, it already cleared an AC)? It is used with high dose methotrexate or 5-FU, or these as common in the US as elsewhere?
If it generates $200mm for SPPI in 2009, that would certainly justify a somewhat higher market cap, ignoring Satraplat.
"9 out of 10 biotechs make exactly this error
"- they project forward the event rate they see during active enrollment or shortly thereafter to predict when they will hit the event number. Yes, it is a credibility issue, but given that it encompasses 90% of biotechs it isn't a real separator."
I call BS on this one. It is impossible to believe anybody even remotely familiar with clinical trials would make this mistake. What you are seeing is just intentional deciet by companies to keep the share price up.
"90% of biotechs spin clinical trial news" would be a fair statement.
DOA = Dead On Arrival
It's clearly not negative,
but it's hard to know how positive it is.
Really, the key to what is going on would be the exact nature of the FDA discussions that led to the submission. There are 2 points of view here.
1) The FDA wants to find a reason to aprove, so they asked the company if they could bief up the NDA in some respect to help it out. This would obviously be very positive.
2) The FDA just routinely asked DORB if they had anything else, and DORB dropped a load of junk on them forcing the delay.
And any view in between.
The problem here is that the FDA will stay quite, so you only have the DORB view (which COULD be spun).
Given that the market valued Orbec as near DOA, the uncertainity is clearly a positive.
Nope, it's just cookie cutter garbage.
Read a few dozen 10Ks and you will start to see a pattern in a few things. One is that they almost always state "supplier disruptions" as a concern.
The idea of these warnings is to list every thing imaginable to avoid possible suits (the real concerns are either obvious are not listed).
Satra. pain measurement issue?
Shouldn't this have been resolved in the SPA?
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