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3.5X for Part D
My guess is that the paper says:
$x is the value of drugs obtained under D that otherwise would not have been obtained.
$3.5x is the net cost of D.
Re: Roach, T-DM1, and Herceptin cannibalizim
I have heard this argument before and don't buy it. The whole point of T-DM1 (from DNA/Roach POV) is to protect the Herceptin franchise by both extending the patent dates and improving efficacy. To them, this is just a next gen Herceptin. They could care less about the 5-10% they will pay IMGN on T-DM1, it's the $3-$5B/year that counts.
The only reason to go slow would be if they were certain no other drugs were gaining on them. I would think that would be a dangerous game to play.
Re: Canaccord Adams
And they were quit bullish on INGN until the bitter end.
Given that INGN was an obvious and clear scam, one must consider Canaccord Adams to have 0 integrity.
Anybody who considers there rec's anything more that PR material is sadly misinformed.
Re: Androxal and HbA1c levels
Obviously the DT2 concept came up after the last trial, so the failure to measure glycation in any manner was not an obvious error.
But why should they run a trial now do so? We have will results of the TIMES-2 trial (testosterone in DB2 and metabolic syndrome patients, double blind) in shortly that should throw some light on this subject. See those results first and decide where to go. If T doesn't look good there, they can forget Androxal via that route. If T does look good, RPRX can go back to the partners desk.
Given that testosterone is being used and tested in the indication and Androxal does look to be a potential improvement, it is not a scam (hptaxi's words) even if it does not yet meet your personal requirements for serious consideration investment wise.
That said, clearly RPRX needs Prol., and w/o such does not have the resources to develop Androgel anyway. So it's all kind of moot.
Re: FDA guidance on Diabetes trials.
1) There is certainly no preclusion of trials in a male only population.
Even if you could find such an implication in a non-binding, draft guidance it would be meaningless.
Regardless, the only relevant clauses I see are:
"In general, premarket study populations should be representative of the population for which the product, once approved or licensed, is intended"
"Type 2 diabetes occurs more frequently in Latino, African American, and Native American patients relative to patients of northern European descent. Therefore, attempts should be made to enroll representative numbers of individuals from these ethnic groups during the clinical development program, particularly during the phase 3 trials."
"For all new development programs for drugs to treat diabetes, phase 3 studies should be sized to allow meaningful evaluation of the consistency of effects across subgroups based on sex, age,..."
These in no way imply the trial must enroll females (the 3rd clause is trivially met in a male only study).
2) The CV burden imposes is not substantial
The guidance requests that the trial measures/records certain CV factors, and included CV high risk patients. This is not some huge burden.
Calling "scam" based on these points is pure B.S.
Two words: Japan 1990's
Re: CTIC/SPPI
PGS, Zev does look like real drug, not a POS (bag of feces) as you say.
The problem is simply that people fear it is a PO radioactive S in the literal sense.
So the drug is a bust, and the clown act goes on.
Re: Bio Buyouts
I would argue that a more reasonable number to put up for IDEV would be $5.4 a share (where the market has generally valued it).
That would be a 74% premium.
Yes, I know this makes the process somewhat fuzzy, but clearly more accurate. Especially given the fact and investor can cash out at that number.
I imagine several others have the same issue.
Dew, I find charts 75% accurate predictors.
They get the Y axis right half the time and are perfect on the X axis.
Re: ZGEN quiz
There was a $20M license fee for the year which would not have to be amortized.
Do we have to find the last $1M to get full credit?
"Pefect execution"?
If the trial was run the way you are suggesting then it would closer to perfect execution of a scam. Not to mention the causality violation in maintaining the 2-1 balance by adjusting the recruitment process based on drop-outs that had net yet occured.
The correct answer is along the lines of this:
Trial enrollment: 21/21/21 (placebo/50/25)
mITT poulation: 15/14/14
Dropouts:15/5/7
The DOs are not the delta between enrolment and mITT, but it is quite possible that a few of the DOs were in the non-mITT group (the 3 osteos and the non-endo might all have been legitimately excluded).
The 2 issues the skeptics have are: :
1) Why were so many patients excluded from the analysis? Maybe there is a valid reason, but we have not seen it.
2) After DOs you have a very small trial. The placebo arm had 1-3 patients complete the trial. The entire trial had 20 or less completers. With so few, why would the call an early halt when we seam to believe the safety data (and not the P3) is the critical path?
Maybe it is all just some honest haze, but I would be more inclined to believe that the data is somewhat nebulous and RPRX is spinning the best side of it.
Re: RPRX , charmed1
RPRX knows full well these issues are floating around.
Is it to hard to understand that if they had a real good answer they would just print it?
We are not talking about stray details here, we are questioning why they choose not to publish top line data in any real sence?
It's getting very clear on this one.
Re: RPRX, so what do the numbers mean?
So the dropouts numbered (14/5/7) for Plac./50mg/25mg arms.
Was this out of the mITT population (15/14/14). So you would have only 17 patients completing the trial, and only one in the placebo arm. Let's try a sensitivity analysis on that one
If these dropout numbers were in the full ITT population, then the numbers have other issues. What ITT dropouts were excluded from mITT and for for reason? It can not be all, the math fails. [The ITT population was around (20/20/20), since enrollment was cut short of the (25/25/25) design]
Why do we have to guess at what the numbers are?
Question on viral breakthroughs.
Are they "instantaneous" (i.e., a single unlucky mutation does you in), or "gradual" (there are some low level of mutations that slowly overwhelm)?
Re: PIPEs and shelfs
I think it is a little more complicated. The SEC rules on restricted vs. unrestricted shares come into play.
Restricted shares can be sold w/o a lot of the regulations covering a public offering of the shelf shares, but they can only be sold to "qualified" investors (what pure crap here by the SEC).
PIPE's go off at the discount becuase nobody thinks the market can take the dump of a secondary.
The regsistrational costs are irrleveant, in either case the company eventually pays the modest charge for registering the shares.
So, if you are selling shares on the shelf and don't have enough, just register more. You can't toss in unregistered shares to the public.
OTOH, if you are about to do a pipe and some some shelf shares, it might cost more in SEC regulation overhead to use shelf shares vs. unreg. shares that must be registered later.
Re: "biancruptcy"
LOL, can we cross post it on that inane GNTA board?
Re: "Is there a link to the list of panelists?"
http://www.fda.gov/ohrms/dockets/ac/cder09.html#PulmonaryAllergy
Under "Pullmonary..", Draft Meeting Roster.
Re: "Stat guy doesn't get to vote!"
I didn't mean the FDA stat reviewer, Dr Liu who is of course non-voting. I just assumed one panel member would be a numbers guy because there was one on every other panel I followed.
In this case though it looks like I am wrong. All MDs.
BTW, I don't even know what the story on the drug is. I was just looking into it in case there was a disconnect between the AP story and the reality that could cause a bogus price movement. Best of luck.
Re: What does X mean?
It means I am to lazy to look up N where
N=Number of voters on the AC panel
and
X = N-2
Re: ARRY's working capital.
It is around $50M, but people need to understand what the term means. It does not include any long tern investments (or debt).
So the difference between the $100M numbers and $50M is a combination of about $25 in both current liabilities and long term investments.
Regardless, Thomas seams right that there is no cash issue barring a complete disaster.
Re: Pg 36, Dyax, FDA AC's in general
"The application supports the efficacy of ecallantide ..."
Interesting, I honestly missed this on my first pass.
What puzzles me is the clear difference between the "Clinical Briefing Document" you are citing and the "Statistical Review and Evaluation" document located about 4/5ths down in the document that I was focused on.
I guess this makes it very likely to get a thumbs up by a vote of X-2, with the stat guy and some random person dissenting.
RE: (Dyax) "but he's recommending approval."
I see nothing close to this. The -3 trial was not stat sig in the ITT population, and the -4 trial was called not-robust, and having a different characterstic post trial size change. And I see not even a hint of positive recomendation from the stat guys.
I do assume you are talking about the FDA's briefing document, not Dyax's wich was what genisi link to?
From the FDA:
"Issues identified in the phase 3 studies suggest that there is a lack of consistent and substantial evidence to support the efficacy claim of ecallantide."
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.