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Re: Is DNDN well managed?
I lean to NO on this vote, but I think your simple ref to the financials does not make much of a case.
Where I would stake the claim is that some more quality early P2 work could have been bringing a much better designed registrational trial to a conclusion about now (with similar costs).
The business with changing 9902 based on the Gleason score datamining way back was just a start.
The latest change to Impact can still not be explained to me.
Re: Vasomax.
I have no idea why this matters, but my view is that the drug was DOA market wise.
The problem I saw was that it would require the patient to be monitored after the first use for a particular AE (I forget what, I assume CV related). This would place it at such a disadvantage to Viagra that Schering threw in the towel.
Corp, re DNDN and valuation.
I strongly agree with your concept here that you need to weigh the PPS against the % chance. 2 years ago on DNDN many thought it was stupid to be long going into the AC meeting, But even Dew seamed to be thinking around 25% chance, and that would have made it a good bet.
As to now, I have no need to decide so haven't. I was not in over the winter because of the obvious fact that "early news is bad news".
DNDN will hit $20 easy if it hits stat sig, but I think the odds are not very good. The best investment position might be after a PPS collapse on a modest miss. Also, might see some interesting option plays.
Re: DNDN Provenge's curve shape.
Yes, I do mean the shape. I agree the 9901 data was likely "lucky" (as the 02A was "unlucky").
The shape also cause H/R to underplay the real benefit if the data truly does not fit the proportional hazard model. The tail is downplayed for 3 reasons:
. Less events to sum in.
. The greater time between events towards the tail matters not to log-rank.
. Enrollment curve effect causes less tail data.
BTW, with all the "pro"arguments I am making do not assume I am long here. The Dec. 304 hit may likely be a nightmare. Even though I do strongly beleive Provenge is effective, this trial might kill it.
Re DNDNs 20% improvement in MEDIAN survival really downplays it efficacy if the "true" H/R curve comes out like 9901.
Drug A: You are 50% to live 8.4 months vs 7 months, but no improvement in 3 year survival.
Drug B: Same median, but the 3 year number goes from 10% to 30%.
That tail is a real solid clinical benefit in my mind.
And there is still considerable hope that use earlier (around time of surgery) could be better still.
P.S., I am not looking at the data, so no pretense here to be exact. But the concept does match the data.
Re: DNDN 3 failed trials.
The point is the trials are failing, not the drug. There has been no evidence at all that the drug is not effective. As the FDA pointed out, all the evidence is pointing the right direction.
If the curves look good but miss .05, the odds are excellent on a sufficiently powered new study.
And I will officially join the kool-aid crowd now. It is not impossible for the FDA to accept a near miss.
BTW, to slightly change an earlier point on the TTP p value of 9901. I do believe the .052 number is valid, just that the clerical correction post lock is something the FDA will never accept (and rightly so).
Re: DNDN survey and what action SHOULD they take.
But let me try it this way. Suppose Provenge hits P=.075 with a nice fat/long tail on the H/R curve? Certainly possible if the separation is late.
Now we have an interesting situation. The drug might look quite effective clinically, but a poor trial performer because the tail contributes little.
With the 9901 trial primary P at .082 (I wont accept the .054 value), the previous survival data, and Impact; one would assume the odds are very good the drug actually does work. Let's remember that a P value over .05 does not mean the drug is probably not effective.
So do you really toss it out? I don't get the logic, if we just called these trials P2s, would not anybody start P3 trials on the data?
Personally, I have no problem with them resubmitting the BLA if the curves show a clear separation with a reasonable P value. If you believe the FDA was on the fence last time, then they could go thumbs up.
RE: DNDN poll
Can we change our votes now?
I was in the no/yes camp, but the early event hit looks bad.
RPRX, far better to be silent than 2x
Really, there is just NO way the 2x number is a good representation of the data.
To start with, they could just release the %/arm (is 60/30/30 right?) and we could all decide for ourselves if the 2x is the right way to look at it.
It's really simple, if a small bio ofuscates data, it is bad, period.
The problem though is not the drop out number, but the fact RPRX is keeping mum. Skeletons.
Question. Of the original trial design what percentage made it to the finish in the treatment arms? 17 out of 50 or something?
"I prefer to call it what it is: counterfeiting. "
Let me lead with this comparison.
A puts his cash in a bank. The bank lends the shares to B. You now have more cash than the US Treasury printed.
vs.
A puts his certs in a broker. The broker lends the certs to B. You now have more shares than the company issued.
Really, the difference is not that big.
If you are going to reply about FTD's, that is not my concern as a retail short.
P.S., certainly not short here. Would have bought in just after the finance deal but was tapped out (times were bleak).
OT: more on A350 floating,
The aircraft has a switch the pilot can throw that cuts off the air vents between cargo and the passenger deck. This effectively traps the air in in the lower deck, not allowing it to escape out the exit doors once opened.
W/o this, it would probably sink way to fast for the pax to get out once the doors opened (unless they were lucky enough that the mostly empty fuel tanks stayed intact).
Re: JP Morgan Best Worst
Can I nominate those companies that decided not to archive their presentations as worst? Kind of a field entry.
Re: DNDN
Gold quipped "the next several months will be very exciting"
I think this translates to Chinese and back as:
"May you live in interesting times"
Seriously, thinking a long time-to-evenpoint is good is somewhat bogus. But a quick pace?
They need the placeboe arm to have very bad luck.
P.S., the IV board is funny. Some are saying this is good because by april they will be able to report on 340 or so events. Others say they will combine all 3 studies, so it's a lock.
So TARP money is now for buyout of Wallsreat firms?
What a F'ing joke.
Re: ZGEN's $287M for non HCV indications
What is the chance that this is really kind of BS? Presumably their is no cost to BMY for agreeing to this clause (assuming it is well defined). Yeh, if they want to run trials for cancer then a payment is possible, but perhapse they have 0 intent of ever doing such. Nobody will ever see the fine print.
Maybe a $1B deal just sounds cool. Gets the new management off to a flying start.
P.S., I am very long ZGEN so not bashing here.Just very much a cynic in Bioworld.
"ATryn is one. What’s the other?"
The GOATS! (NADA)
P.S., I think you are reaching on Flemming questioning the trial design being N/I, but I will wait to I see the real transcript before I say any more here.
"What quip are you referring to?"
The first clause obviously.
Regardless of weather the it might be true/false, for the stat guy to bring it up makes no sense for a non-inferiority trial.
"Statistician Fleming questioning if ATryn is better than SoC; and availability of plasma AT"
I hope this comes out better in the full transcript, the quip sounds idiotic as is.
GTCB statwise on the P3 and earlier PRs
"2. ATryn met the non-inferiority threshold on the incidence of DVT because the lower bound of the 95% CI was >-0.20. During the 7-day treatment period, there was one case of DVT in the ATryn arm and zero cases of DVT in the control arm. (GTC’s own PR from early 2008 had said there were no DVT cases in either arm, so there’s a discrepancy but it’s evidently not consequential.) From the statistical table, I infer that one additional DVT in the ATryn arm (i.e. 2 in the ATryn arm vs 0 in the control arm) would have caused the non-inferiority threshold to be missed."
Going back in time, did not GTCB release results before the last 2 patients had been treated and claimed they were golden regardless of the outcome of those two? Obviously (If I remember the facts right) that could not have been the case.
IDEV and stock option question
IDEV is being bought at $4.5 + up to $3 future milestone payouts. If one sells the Jan 10 $5 call how does the future payout work?
In logic, you would owe the future payouts if/when they happen. A little complicated since you might vanish, but I guess the option board/broker could hold an escrow to make certain it works.
The question arises as I consider selling these as covered calls to close my position. At .65 they net me close to fair value (IMHO) w/o having to wait for any excess over $4.5. Also, if the testosterone drug is delayed past EOY 09 it is possible the options don't excise, and I would have a free shot at the $3 payments.
Comments?
RE: "Surprisingly positive review by the FDA"
Agree 100%. I don't see a single negative issue raised by the staff (other than repeat use, which should have been known going in).
They will get hit with required P4 for repeat use, and likely a black box until that is completed.
Re: We may get Posting of Briefing Documents
It's up now.
FDA "Conclusion" in Executive Summary:
"ATryn at the recommended dose is effective in reducing prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. The safety profile appears to be acceptable. The immunogenicity on repeat exposure remains to be evaluated. "
Re: TDM-1 and IMGN
As PoorGradStudent has pointed out, the undisclosed royalty figure might be very low. It is certainly well under 10%, and PGS goes for well under 5%.
Even so, at 5% it will not be chump change, and the "validation" alone will be worth several $/s.
So, add me to the puzzled list. But discount the SeekingAlpha story. It's just a post of slightly old news submitted by drugrunner (a perma-bull of the IV board).
Fe BPUR and other blood boys.
My real question in this space is how do you ever run a good study?
To be honest, I think the FDA has been bending over backwards to try and allow such studies, but it is still difficult.
Who will consent to use a product that hopefully is a good as blood?
Can somebody in an ambulance sign a consent form?
I think there is a very real need for a product in this space (blood demographics at the least).
Re: NFL BAL vs NE tiebreak.
No, BAL is 2-3 against common opponents, they lost to PIT twice and IND once.
Next up is combined W/L record of defeated opponents. Assuming the rule is that doubly defeated opponents count twice, the records stand at:
NE: 56-84
BAL: 55-84-1
I guess this can't be a tie under your rules, but NE is a slight fav. to win. If we guess 55% for NE here (I'm not going to bother and count up how many relevant games are left to do the math exact), then we have an additional chance for NE of:
NE results .25
BAL results .25 (before last night, now obviously .50)
MIA/NYJ .50 [the looser of week 18 is 50% to have lost week 17]
Schedule TieBreak .55
About an extra 1.7%
Re: The pats lose all tiebreakers?
In my senerio (Pats L/W Bal W/L) Then
Head-to Head: 0
Conf record: 7-5 tie
Common oppenents: (Maimi/Pit/Oak/Ind) 2-3 tie
Strength of Victory:
NE:
KC: 2-12
NYJ: 9-5
SF: 5-9
Den: 8-6
StL: 2-12
Buf(2):6-9
Mi(1): 9-5
Sea: 3-11
Oak: 3-11
======
63-94
BAL:
Cinn(2): 2-11
Cle(2): 4-10
Mia: 9-5
Oak: 3-11
Hou: 7-7
Phi: 8-5-1
Was: 7-7
Dal: 10-6
======
56-83-1
It's unclear to me that the Pats must loose this one.
Re: 11-5 bye-bye
It can happen in the NFC also this year. But I really doubt it.
NFL Quiz: On more math, there is an answer.
It is impossible for the strength of victory and strength of schedule to both be tied. This could only happen if the losses have the same strength.
The non-shared losses are :
NE: Jets/SanDiego/Miami/Arizona
BA: Jack./Giants/Tenn.
So if it gets to strength of schedule, NE is out, and the tie always get's broken before points.
And the chance of me getting all the cases correct before I start watching the DA/IND game is zero.
NFL Quiz: There is no answer.
I believe the tie breaker can come down to some of the "points" based rules.
If NE loses to AZ and beats Buffalo, while either Miami or NY goes tits up and Bal. wins tonight but loses next week; then we have a deep tiebreaker between Pats and Ravens. It probably gets broken on victory strength (pct. win of victims) or schedule strength (pct win of all), but not guaranteed. If this happens, it comes down to points.
Anybody want to run the score up?
BTW, this is hypothetical. The Boy's are about to start playing real football.
Re: IDMI's Mepact (L-MTP-PE in the US, was Junavin)
Certainly it is good news for IDMI wrt the CHMP rec.
I still suspect the FDA chances are somewhat poor. The trial was better suited for EMEA than US due to the inclusion of a drug that was not approved in the US, but was in parts of the EU. Also (it shouldn't matter but likely will) this will be a "do-over" with the FDA and the first submission outright sucked wrt clinical data accuracy/completeness (even the solid longs will agree with that).
Still, one would think even EU only would be worth more of a pop in PPS than it got yesterday. At worst they could spin off EU rights for enough cash to remain quite viable.
I'll pass on the 8k tea-leave readings.
Re: IMGN and TDM-1 valuation
[Reposted to correct ticker symbol, if Mod. can delete old post TIA]
I have seen "mid-single digit" royalties tossed around on this one, but can not trace it back to a company statement. Still, I will hope for something closer to 5% than 2%.
If the drugs becomes ubiquitous for Herceptin applications, we are talking royalties of $100-200M/y.
That is far from insignificant to IMGN with a market cap of $220M ( and an enterprise value of only $160M, if I can be hypocritical ).
Besides, getting any DAC to market will be worth far more in stock PPS than the market value of the drug.
Dew, Re SGEN and equity valuation
For "normal" companies, you are 100% correct that equity value is a far better measure than market cap. But in the "biotech bleed" world it gets a little fuzzier. There is often no reason to believe the cash will last.
I think many would consider run rate to be more important than the balance sheet. It is of course difficult to put this into a simple metric, but it's there somehow.
In the particular case, I grant SGEN some extra value for the balance sheet, but with similar run rates it's not near the full balance sheet delta.
Re: SGEN vs IMGN
I own some of both, so I think I can be unbiased here.
First, I like the IMGN valuation better. So don't get me wrong here.
SGEN has 2 pluses.
I think many view their technology as somewhat newer and better. I am not saying I support that logic, but it's kind of the feeling you get.
Also, SGEN does have other pipeline products, whereas IMGN is really ADC or nothing.
On finacials, SGEN has a better balance sheet, but the burn rate is worse.
Overall, I like ADC tech because it is potentially a patent extension method for MAD holders. If that happens, somebody will make good money there. My SGEN play was just diversifying within the technology.
Re: SGEN valuation
You are ignoring their conjugate technology. Not proven yet but it is certainly of interest to DNA and a few others.
Re: Worst Bio exec '08
Can we nominate scamsters? If so Nance of INGN leads the field.
Other than that, Bruce Carter (ZGEN) gets a nod for trying to set up a marketing arm for RecoThrombin. If he had just sold the drug after FDA thumbs up, the stock would not have been slammed by the slow sales (and it's also possible sales would have ramped up faster, I doubt semi partner Bayer cares much).
One could say this is monday morning QBing, but even at the time many wondered why a pure R&D outfit would try and market a drug themselves (even with help).
Re: NASDAQ stock ownership numbers.
There is often considerable overlap in reporting persons. Nasdaq just sums the reports, even though some are reporting the same shares.
If Bob owns controlling interest in BobsBioBoys, and BBB owns stock in XZY, then both will end of reporting these shares.
If you really care in the case of BMRN, you can look up the top 10 or so institutions, and you will almost certainly see some are related.
More on CTIC investment worthiness.
Disregarding the past history of CTIC and its management, CTIC is still worthless wrt equity ownership even if the Pix has some value.
The reason is the company is now owned lock, stock and barrel by creditors. Even if the Pix data continues to look good, the debt holders can take you out for $0 before you make a penny.
[I am not going to read all covenants to prove this, but at the present capital structure it's a given. ]
The only way equity would see value is if Pix was worth upfront at least $100M or so. And this is not in the ball-park.
WRT trial data, the issue will always be accumulated cardio toxicity. It is just not possible to see where Pix is from these results. Need the real data.
Re: "Posts state that events years ago have no bearing on the operational plans of RPRX"
What clearly had no bearing was the Dunbar lawsuit. She admits throughout that she signed several contracts granting away her rights.
Though in the dispute between her and the university the layer issue clouds it up, there was no such problem with her contract with Zonagen. She signed over the research material, then refused to provide it.
Joe came in after the contracts were signed, and presented a case where an employee was effectivly stealing research material that the company owned.
If Baylor conned her into signing more than she had to, that's between them and is truely irrelveant here.
Re: "I’m not sure what you mean by invalidates—please clarify. "
Because it's a 2-sided test. If the curves have a significant area with placebo outperforming, the treatment arm gets a P benifit from those data points for being different, even though it's the wrong side of H/R.
My understanding was that in practice (i.e., FDA eyes) the 2-sided P value would be rejected for showing a benfit if the curves were not visually clear wrt the treatment arm being on the correct side throughout.
If the curves go as my guess (TNF doing worse for 12 months or so and better late), they are out of luck even if the log-rank number hits.
Oh yes, it is possible the curves have only some minor early crossing, gets much better at 12-18 months, and a continuation of the 12-18 month effect could provide a winner.
And it's possible that biologists will discover a species of airborn pigs.
RE: GNVC– I found this analysis interesting and persuasive.
Would it not also be the case that the KM curves very likely are crossed well into 12 months are so? And if so, that invalidates a log-rank test?
And the company elected to conceal the curve?
I doubt it matters how the final events play out, unless by some miracle enough early events come in favorable enough to change the picture (I have no idea if enrollment timeline even makes this possible).