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Quiz: Sorry that is incorrect.
The calculation that did this ignored the fact that Main and Nebraska are not winner take all.
Thus, solutions that were rejected because they included a small excess might be brought in line by reducing the the votes received from one of those states (but not going to 0).
RE: INGN: "if the subgroup was prospectively defined before looking"
Just a few quick points:
. The trial was OPEN LABLE, so the results were known before the biomarker selection criterion was drawn up.
. There were 2 trials. One has vanished. How do you think those patients faired?
. There was a preivous effort witha different subset selection on the same trial, and it failed.
Really, these people define Bio-scum.
20% was easy
You posted several posts by Dew claiming sales in the high 90's and up over 100.
As DNA fairly quickly corrected to back around $80, its doesn't seam a stretch to guess a 20% gain was fairly easy.
Personally, I have no idea how Dew does, nor do I care. His post here was obviously a response to the Doc's attack against him for posting neg. on RPRX. Both of them are acting like children on this one.
IO, Re Dew's DNA short:
Dew admitted that he blew the first short, but the rest you post would all have been solid winners (about 20%).
If you want to get Dew's "goat", there is a much better example
RE: "you can always pick up 100 shares".
Funny, but I often actually do something like that.
If I own a stock that I see potential in, but am selling it because of short term issues, I sometimes keep token shares just so I keep an eye on it.
OK, call me stupid
ABPI, BiovaxID and the smell test.
So the DMC recommended that the trial go to it's scheduled completion. That part of the PR certainly makes them fit for a politco's spin crowd.
The part about the DMC pushing for registration was just funny.
BTW, this drug is a slightly earlier version of GTOP's MyVac (which blew up bad last December). It is perhapse possible that the orrginal is better (the problem in the orriginal version AFAIK was a huge mfg issues). As I understand it, GTOP's MyVac was somewhat less specific, easier to make, but perhapse not as good.
Or we just will just have one more super expensive test to determine who lives longer.
And another stat question.
As I play around with a calculator, it seams that the final P value in OBF with a single interim peek will be around .48 with the interim at 50% of events and drop to around .4 as the interim gets out towards the 90% event time.
So, if the trial was always using OBF, how did pushing the interim back help the final alpha allocation? It should have hurt it.
RE: INGN
. not a single P value comparing Advexin to the comparator arm.
. N=64 (out of a designed 650)
. They changed the subset again
. OS and tumour growth control in the total population was worse with Adevexin (and trending better in the subgroups, but not going to be stat sig)
They are probably jumping for joy in the kool-aid crowd on YMB!
P3, re very large trials.
This has been a harping point of BSR David, and I quite agree.
If you need to run a trial of X thousand to get stat sig, there obviously is a questionable benifit at best.
But if you have n=100 and p=.02 you likely have a much better treatment effect.
There is a real fundlemental problem here in the FDA law/regs. The drug must be proved effective, but the same standard of proof holds regardless of how effective it is.
Drug 1: Another NSAID that shows pain relief N=2000 , p=.05
Drug 2: Improves OS (HR=1.8) in stage 3 NSLC N=100, p=.06
Which one should be on market?
A really dumb Q here.
Has DNDN stated what the new alpha allocation is? I have not seen it anywhere, but have not listened to all the calls.
If not stated, how does anybody estimate the interim chances?
Going blind, I have to admit I am in the negative mindset wrt the interim (not the final though). I think the combination of the tail effect and a likely small alpha (.005?) is not likely to produce a win.
"But what if that is one of your consideration regarding getting some skin in the game?"
I guess Doc doesn't believe you should evaluate issues before you buy into a company, only after.
Re. the stock purchase.
I have definitly seen at least one case where a company used token buys to help inflate the stcok price of a scam.
I do not believe this is this case here. Joe does not act like a scam type guy. He may be a little over agressive on timelimes, he may be a "true believer", but he doesn't sound like a con artist.
He bought the shares because he truely believes they will be more valuable later.
Shots on goal.
Sodium chloride will be stat sig for prostate cancer if you take enough looks at data sets.
I really don't want to get into the debate of why they changed the SPA, but it is CLEAR that the 360 event data will not do the trick.
PDLI: Royalty rate per drug?
To my knowledge they have not disclosed this. So yes, there is a negative danger that the rates on drugs that rate to grow are lower than the rates on the duds.
To be honest, I am only in this for the recovery pop after it got slammed awhile back for failure to sell itself. Now that it has recovered I really don't care much.
Dew, the PDLI issue isn't about the divedend.
You are of course correct that this is just a payout of cash that has been expected, and has 0 net effect.
What popped the PPS was the intent to spin of the cash draining crap (parden the language). With this gone, one just needs to evaluate the value of the royality revenue stream, which seams to justify a price in the $14 level (I assume nobody assigns any significant value to the pipeline spinoff).
Of course we have a weird situation here. Given that the resultant company is a straightforward cash play, it does allow it to be fairly valued and the "efficient market theory" really does work
There is really less reason to buy now than a month ago.
IDMI L-MTP-PE approval?
From 20,000 feet you still have a drug that failed the primary endpoint of DFS in a single trial going to the FDA on survival. But the details are significantly worse than in the better known example of DNDN's Provenge.
In the AC meeting last year when the drug (then Junoven) was voted down the FDA presented briefing material that was very negative.
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4301b1-00-index.htm
The main points are:
. Numerous trial flaws (no defined endpoints, unplanned interims, serious dataset questions). And a big one was that randomisation for MTP was done well before the drug was used (which adds noise).
. The assumed primary of DFS only hit stat sig if results from another experimental drug were included. W/o infosfamide there was little effect. [Read the transcript for the place where the lead investigator tries to tap-dance around the SOC issue, very funny]
. Much of the OS power in the results derived from events before MTP was administered. W/o events from that period, the P value was around .5
Yes, they have recent follow-up data which pushes the OS P value to .03, but that doesn't fix the other issue.
Approval, nope.
BTW, the phrase "possible clinical benefit" sounds to most like "the P2 worked, on to P3".
RE: AGN, JNJ Push Gastric-Banding Surgery
Maybe this a dumb question here, but since the patients are not changing their dieatary habits (a given, else they wouldn't need surgey), are they not going to likely suffer from malnutruition, etc. ?
Are there any long term studies on this crap?
It stuns me that people would rather have a doc cut them up than make a serious attempt to eat healthy.
For those that have psychiatric problems, can we not address those first?
I am really not as insensitive as this seams, I just think we all make a big mistake as we move away from INSISTING the solution is lifestyle first.
"I think management will lower Recothrom's price..."
I doubt this would happen until they get a chance to see what the real sales are. Remeber, they have to wait for :
. inventory of bThrombin to run out
. any contract to expire (probably)
. the next meeting of the purchasing dudes (whatever hospitals call them).
Likely they havn't had much at all of this yet (if any), just samples. If the 6 month sales figure don't start to show a solid uptake then we can wonder.
"Before the recent rejiggering of interim and trial size I had thought about going long after the failed interim."
The play is still a possibility, given that we might well see a larger PPS drop after the interrum than under the old SPA.
If DNDN drops to around $4 (and I would expect even lower is possible) on a failed interrum, what is the investment decison? Risk/reward of likely 5 to 1. Odds anybody? Perhapse some calander spreads could even be a better play.
EDIT - proces are in todays world, and of course subject to serious changes before then. But the concept holds.
"To increase the Series D authorization above 15,000 shares ..."
This "roablock" is very logical. Ths only purpose of the seies-D is to convey a BOD seat. If the limit did not exist, GTCB could have taken the seat back anytime they wished just by issuing 15,001 shared to the treasury.
I agree with you that the most logical point of the move is that LFB is willing to let GTCB give their BOD seat away in order to facilitate a deal. They might have a gentlemans agreeman to get their guy nominated back on next cycle, or they are comfortable enough working with GTCB that they don't care.
"This possibility was discussed earlier in this thread, but it’s hard to believe LFB intends to dump shares at these prices."
I actually didn't mean to imply this. What I was thinking was the remote possibility that LFB was just cleaning up their books by reducing less liquid assets (and technicaly the D might be viewed as such as there is no market, but IANAA). In todays market, this would not be an irrational corporate directive. Really was just trying to list anything I could see as a driver.
In retrospect I don't believe this to be a possibility.
io, what you posted wasn't the issue.
In response to the DD post wrt 2 small p drugs that got approved with difficulty, Y3 wrote
"your comment above reads that you concede Proellex will in fact be approved."
DD had clearly not conceded the point, his post did not state he did, so he told Y3 he was wrong.
How does the fact that the other drugs got to market change DD's opinion that Proellex might not?
You can debate the underlying issue all you wish, but the DD post cleary did not "read" as Y3 posted.
I still think DD could have given a better example. Satraplatin comes quickly to mind.
RE: [OT]Goodbye, Silicon Chips
4 years left for silicon?
And I thought some people in the biotech space were prone to "hype and awe" attacks
One last LFB post.
The only advantage of the class D prefered over the common is the BOD position (sorry about my earlier comment of BK pref, I should look before posting).
There are 2 negatives that I can see.
1) If the shareholders rights ever tripped (which would make the common twice as valuable). Seams kind of unlikely to me (has one of these EVER tripped?).
2) The common is a liquid asset (or would be if LFB registers it, or insists on having GTCB register it in a future offering). I have no idea if what LFB's financials are, but it might matter.
I see no reason to go with the 15K max class D theory, as the only reason why why somebody would want this is for the BOD seat. Other than that the common works just as well. Why would they need to issue more class-D?
Seam most likely the mystery remains unsolved.
Time to sign off and get some sun.
http://yahoo.brand.edgar-online.com/fetchFilingFrameset.aspx?FilingID=4691888&Type=HTML
Go seek, RS not the reason for the LFB action.
The preferred would adjust with the the split.
Do agree that there must be a reason though.
LFB conversion?
There really has to be a reason for this, you don't give up the BK preference for no reason at all.
Poison pill?
OT: BCS's Cayne
In fairness, he didn't sell it 6 months ago for over $1b despite having full visability into BS's collection of "better than sub-prime in name only" mortage portfolio.
OK, truth told I suspect he was just to old and egotistical to see the pending implosion.
Y3, I will make this even simpler.
Read the first 2 lines of your post :
------------------
""Of course a SPA doesn't protect you from outright fraud.""
lol,,,You implied "Fraud" by way of the fact Proellex doesn't have a SPA.
------------------
If you can not see the error in your logic it is not worth my effort to try any harder.
Y3, you still are clueless here.
My statement was in response to akas' about the value of a SPA. I was stating that they are not as valuable as they shoud be if they can be ignored (see Satraplatin).
When ethan77 missed this, my follow-up post to ethan clealy explained it:
http://investorshub.advfn.com/boards/read_msg.asp?message_id=27835766
Actually, my post was somewhat supportive of RPRX's decision to not get a SPA.
Your logic here is "A SPA might be FRAUD" implies "Not having a SPA is FRAUD".
I suspect your logic is "Poster A posts some negative comments" implies "Poster A should be attacked for all posts".
When you clowns argue exact phrases and spelling while twisting a post 100% from the intent, it says about all we need to know.
Re: "Is it time to ban a few posters from the board?"
I would recommend a subject matter bar of all "my stocks are better than your stocks" posts.
If you are really going to start banning any poster who expresses negative opinions, you can start with me.
CTIC Pixantrone PR, more from Comedy Central.
Before reading the PR, here is the background.
Pixantrone:
A dox. varient that is designed to reduce the cardiac toxicity. Seams like a reasonable candidate, but as usual CTIC tries to shortcut the trial process.
EXTEND trial:
"The EXTEND clinical trial is a phase III single agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines" N=320
What happened:
The trial enrollment started slowly and came to a near stop (single agent?). The trial was just now terminated at N=140
The PR: http://biz.yahoo.com/prnews/080325/aqtu505.html?.v=3
"Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) announced today that enrollment is complete in the phase III EXTEND (PIX301) clinical trial of pixantrone (BBR2278) for patients with relapsed diffuse large B cell non-Hodgkin's lymphoma (NHL). An analysis of the data is expected in the second half of 2008. Based on prior discussions with the U.S. Food and Drug Administration (FDA) the data could provide a registration path for pixantrone if final study results are adequate for submitting a New Drug Application (NDA) with the FDA in early 2009 with a potential approval in 2009. A total of 140 patients were enrolled in the study, 97 patients are currently evaluable according to Histological Intent to Treat, or HITT, criteria and will be included in the final analysis of the study."
Right.
P.S., these guys could set a record for time between successive reverse splits.
What does "check the box" mean?
Really guys, the more you stand on thse pedandic arguments the more you seam like robot pumpers.
Y3, other high P drugs drugs
in early (and even P3) that didn't make it are probably quite common.
Can we consider Satraplatin and Vasomax examples? I suspect more experienced biotech investors could name dozens more.
And BTW, it was YOU who used the FRAUD word wrt RPRX. But I guess you would rather just thrash randomly with BS than actually read a post you respond to.
"Which opinion are you referring to?"
The "majority opinion" I refer to is that the cause of the fall-2007 drop off in price was that Coreg-CR sales were falling due to Coreg-IR being generic.
I though the OP was about that timeframe, so you post about generic -CR probably was not the (downward) price driver.
Of course, I am slightly uncertain about this whole thread, so maybe I got lost in who meant what where.
It certainly sounded to me that he called the upcomming Andro for fertility trial a slam dunk.
Re FLML Coreg dates
The OP was about the flame out in 2007, so these dates certainly seam reasonable.
But I will disagree with Dew and go with the majority opinion that Coreg-CR can not sell against the generic Coreg-IR at a fraction of the price.
Did FLML (or the patent holder) file suit against the challanger? If not, the the generic -CR will be on market in less than a year.
Dew, on the denominator
I did see those numbers. One guess though is that those were the total number of patients at the end of the year, not the start.
If so, this would have yeilded larger % resistant number than the true KM (which would have had a larger at-risk number at most all points). The effect would have been big enough to explain the descrepancy.
Seams stupid, but who knows. It is just a PR.
I think my other guess that it could be changed data over time seams unlikely, as the Y5 data really drives this.
"Could you please explain your post, in plain English, to a non-stat guy?"
I am not certain if you mean the whole post or the quip at the end, so I will address both.
1) The no serious discussion quip.
Many posts ago another poster questioned why we had little serious discussion on this board. I decided to try and get things going with an admittedly negative post. The response from a board leader was a personal slam as opposed to any effort to debate.
2) Real issues.
IDMI might be a good investment, and MTP-PE might be a good drug. What I posted was that the trial used to support the NDA last year was a dismal failure. The FDA tore it to shreads back and forth. This is NOT to say the drug failed, just that the trial failed because of it's deisgn.
Re: 5Y baraclude data
If this is followup data as time goes by, would we not also expect more data points in the earlier years that could change those nunbers?
I also would expect a difference between the actuall KM curve and calcualtions done by collapsing the time interval to 1 year (but this should go the opposite direction unless we don't really know what the at-risk number was in the PR).
OK, I am bashing w/o DD
Quotes per FDA :
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4301b1-02-FDA-redacted.pdf
The experimental arm issue:
"INT 0133 was a multi-center randomized open label study. Two therapy-related experimental questions were investigated in this study.
1. A comparison of two chemotherapeutic regimens: standard arm (Regimen A: high-dose methotrexate, cisplatin, and doxorubicin) and an experimental arm (Regimen B: a modification of the standard arm with the addition of ifosfamide).
2. The contribution of MTP-PE given in combination with the chemotherapeutic regimens - Regimen A with or without MTP-PE and Regimen B with or without MTP-PE."
"There are three main issues regarding the DFS results:
1) The Applicant’s result is sensitive to changes based on FDA review of CRFs, patient’s eligibility and investigator’s additional follow-up data;
2) The Applicant’s result is driven by an experimental arm which performs worse than the control arm; and ..."
"Applicant’s result is driven by an experimental regimen performing worse than the control regimen"
[The experimental arm refers to the arm with ifosamide+SOC. Look at the KM curve on page 21. The Green and Blue lines show PFS data w/o ifosamide. They are IDENTICAL]
You: "Frequently trials do not go as planned and require revised statistical procedures and often more data gathering. IDMI had to do the latter"
Complete BS. So you are a stat guy? Then you should understand you can't just go changing the plan and gathering data until you hit stat sig. See for example DNDN where the FDA did not allow them to correct a simple clerical error in the data set. And here you want to just keep adding data to the post hoc (per FDA) OS analysis (after all agree the primamry endpoint failed).
I completely understand why there is no serious discussion on this board.
"Why has the discussion not moved signifigantly to this board? "
OK, I will take a try.
Junoven by any name has NO chance of being approved by the FDA based on the new data (argument below). To present an "investment thesis" in the stock requires an argument that acknowledges this fact. If anybody would like to procead on this I am all ears.
Does the remaining pipeline justify a buy?
What is the EU story?
Can they possible perform another trial on a surragte endpoint?
To be honest, I am not in IDMI either way. If somebrody has a reasonable argument to be in (that doesn't just ignore the Juno trial data issue) then I will happily debate. I do like to invest in somewhat busted biotechs.
----
When IDMI took Junaven before the FDA, they got shot down on several serious issues. In order:
. The trial had no defined stat plan or endpoint
. Juno only showed a benifit when another UNAPROVED drug was used concurrently. W/o the unapproved drug, Juna didn't show a benifit.
. The database was seriously flawed.
Getting a drug aproved on a single trial requires quality data. This trial was the complete opposite. There is NO chance that adding a few UNBLINDED datapoints will change the real issue.