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So I sold a few 7.50 puts last month ... quite a few, actually ... and, according to CyberTrader, at anything under 7.45 the put would be automatically exercised. Okay, so this is my question:
Will they go by the closing price on Friday or will they take into account the spike in the after hours?
In otherwords, am I gonna make a living wage on Monday or have I hit the mother lode?
:O)
Thurly
(1250 puts sold ... I'm having trouble breathing...)
WHAT'S KEEPING THE PRICE UP?
OpEx ... go look at the OI for August. Will settle where 7.50 is all out of the money.
Thurly
The request was filed on Friday by the CareToLive group. The intent is to exhaust the FDA process for reconsideration and appeal as part of the legal process that they initiated with the lawsuit.
Thurly
David Miller weighed in on BSR re: the efficacy and significance of these results. Worth a read. Subscription required.
I took a small position at 2.18 after reading his piece. (Silly me, I put in limit order at $2 and watched the thing run away from me...
;O)
Thurly
Does anybody know if the PII, being done in India, will be considered enabling of a PIII by the FDA? Are there any issues re: the highly specific, unique and limited population sample?
TIA,
Thurly
David Miller has two Alerts on CORT over the last several days. Well worth reading if you have a subscription to Biotech Stock Research.
The BSR licensing agreement prevents me from posting the contents -- sorry!
Hold onto your pantyhose everyone...
Thurly
<< The wait is long, but i think investors are best served by having the company enroll 02B and institute an analysis at 3 years of follow-up for all patients rather than the event driven analysis that is currently in the SPA. >>
I'd agree with that. Given the current political climate (note NYT article today)...
http://www.nytimes.com/2007/05/10/washington/10drug.html?_r=1&ref=health&oref=slogin
...anything less than conclusive data would be a gigantic risk for Dendreon.
If they don't get a free look, why take a penalty? Wouldn't that be utterly self-defeating -- especially if they're not absolutely confident that they will have unassailable early data?
Better to wait, get your best possible data and resubmit a BLA on the basis of that. Anything else, given the forces at play, seems like the ultimate in FDA regulatory masochism.
Let the FDA take the heat for creating a climate so hostile that companies like Dendreon refuse to take unnecessary risks with a bipolar governmental agency.
"We'll be a bridge (to hell), not a barrier..." VonE
Thurly
<< Seems like the FDA had worked very closely with Dendreon >>
That's what they said at Encysive (ENCY). They've suffered through two approvables.
They got a Class I review in March 2006 for the first, resubmitted data and waited and waited... That summer they got their second approvable letter. The CEO said they were close: "first and goal on the one yard line" or some such nonsense. They took a lot of time to submit their answer to the FDA stating that they didn't want to go through another approvable letter and that they would wait until they were sure they had the best response for the FDA's one last concern. They submitted and they waited, and waited ... Finally the FDA said they wanted some of the tabular data reformatted. ENCY responded within a few days and waited ... they finally got a Class II review on the second approvable letter with a June 15 decision date -- a year and a quarter after their initial PDUFA date...
All along ENCY said they were working closely with the FDA on the approval process...
Thurly
I should note that the PII trials, if "spectacular," might be used as pivotal trials. In that case, Elan and Wyeth will need compelling biostatistical results to be able to file with the FDA.
Thurly
<< first step would be to persuade the FDA to give them a free look at 9902B >>
Elan and Wyeth have a situation where they take peeks at their AAB-001 PII trial in progress through a neutral third party. Neither Elan nor Wyeth are allowed to see any of the data. The third company reports out the results of the peeks allowing Elan and Wyeth to see whether they have found the optimum dose/frequency of AAB-001 to determine when they should move on to a PIII trial.
I don't know if there is a penalty for the peeks in this case since, while the data is unblinded, the companies are still, essentially, blind.
Anybody know if a neutral third party looked at the 9902B data whether or not the FDA would allow them a free look?
Thurly
Another WAG:
With EU recommendation due out soon (already communicated to Insmed?) they may be setting up a ROW deal that would set them up in the EU (manufacturing outside the reach of the U.S. patents); help them to fund further research and trials; and provide Insmed the funds to take this cause through the appeals process.
Like I said, WAG,
Thurly
It appears to me that this is all about (narrowly about) whether a party that agrees to a royalty payment has given up the right to challenge the validity of that patent. In this decision, all other issues were left to the lower court to decide.
From the decision:
"Because such an action could have resulted in petitioner's being ordered to pay treble damages and attorney's fees and enjoined from selling Synagis, which accounts for more than 80 percent of its sales revenue, petitioner paid the royalties under protest and filed this action for declaratory and other relief.
"Where threatened government action is concerned, a plaintiff is not required to expose himself to liability before bringing suit to challenge the basis for the threat. His own action (or inaction) in failing to violate the law eliminates the imminent threat of prosecution, but nonetheless does not eliminate Article III jurisdiction because the threat-eliminating behavior was effectively coerced.
and
"Respondents' assertion that the parties in effect settled this dispute when they entered into their license agreement is mistaken. Their appeal to the common-law rule that a party to a contract cannot both challenge its validity and continue to reap its benefits is also unpersuasive. Lastly, because it was raised for the first time here, this Court does not decide respondents' request to affirm the dismissal of the declaratory-judgment claims on discretionary grounds. That question and any merits-based arguments for denial of declaratory relief are left for the lower courts on remand."
I agree with ThomasS that this is apples and oranges. We never entered into any royalty agreement with DNA.
Thurly
<< I also ignored the possibility of an injunction. Fair enough? >>
Hector,
Not to me. You're making an argument about the need for money. You left out a few significant possibilities. That weakened your argument in my book.
I note that you addressed two alternative funding possibilities subsequently. That's fair enough. I expect arguments to get filled out as issues are raised and addressed.
I wouldn't be surprised to find that your forcast pans out. For me, I'll wait to see how INSM does on appeal. LTBH here.
Thurly
Ignores the possibility of a EU or ROW partner.
Thurly
I thought the patent specifically covered direct expression (and fusion? Currently in dispute) using e.coli.
Thurly
In Prostate, breast and several other cancers they may be going up against Dendreon's autologous vaccines (approval next year?). If DNDN's Provenge gets approved, INSM will have a tough row to hoe. Provenge's survival benefit is way impressive. Be interesting to see how that plays out.
Disclosure: Way long both INSM and DNDN.
Thurly
VA Contract Confirmed by IR
Got a message on my machine:
Confirm VA contract with government
For qualified children of the DoD and VA
Indication = Growth Hormone
It's a standard government contract ("just doing standard business with the government") so there was no PR release
My post on IV re: contract --
Re: Contract
I just got off the phone with Theresa Wallk, she said that the VA serves as a contracting facility for the entire federal government. That includes, she says, the VA, the DoD (including all branches of the armed services), Public Health (including for native Americans) and the Coast Guard. She doesn't know the intended use. She says they just do the contracts. 90% of the time she doesn't know the intended application.
To find out intended use, she suggests calling a VA's pharmacy department and asking them.
So I called my local VA here in NYC and talked to a several people in the pharmacy and release of information departments. This contract is so new that it doesn't even come up on their computer system. They tried to connect me to the Chief of Pharmacy, but he never picked up the phone.
Then I called Insmed Investor Relations. I couldn't get through to a real person ... I left a message asking about the contract. Will let you know what I find out if I ever work through the bureaucracies.
Thurly
TRCA Webcast: Says will talk about lawsuit vs. INSM in the breakout session. Is there any way to see/read the content of the breakout session?
TIA
Thurly
Liberty,
Sorry, actually I thought I was responding to Wall and Dew. I have great respect for both, but I disagree with them on this issue.
I just went through a "first round FDA approval" disappointment with ENCY which many had thought would get a first round approval. We're now formulating a response to our 2nd approvable letter. I'll be happily surprised if DNDN gets a quick approval, but you never know what you don't know.
Thurly
Consider Elan's battle with Teva and Sorono -- quite public now:
http://moneycentral.com/content/Stratlabs/Round13/P146283.asp
Competition grows
Tuesday (Feb. 28), Bloomberg reported that Teva Pharmaceuticals paid a marketing agent to publicize an abstract of an as-yet-unpublished article comparing Tysabri's effect on the human immune system to AIDS.
The way the media reported the story made it sound like Tysabri gave patients AIDS-like symptoms. I think the authors of this paper would be aghast to see their research used in this way. It's true that both Tysabri and AIDS suppress the immune system. Tysabri suppresses the immune system when it’s beneficial to do so, such as when you have an autoimmune disease like MS. AIDS suppresses your immune system to your detriment.
Teva's investment bankers have been active as well. Citigroup, you may recall, has a “sell” rating on Elan, which they reiterated about a month ago. Lehman Brothers also has a “sell” on Elan which they updated on Thursday, stating that they expect 50 to 100 additional cases of progressive multifocal leukoencephalopathy in the next couple of years if Tysabri returns to the market.
An article in the current issue of the New England Journal of Medicine estimates the risk of PML to be 1 in 1000. This estimate was arrived at by an independent adjudication committee that had full access to all available data on virtually all patients who had taken Tysabri, either alone or in combination with another drug. In order for Lehman's forecast of 50 to 100 additional cases of PML to be correct, there would need to be 50,000 to 100,000 patients on Tysabri in a couple of years. 50,000 to 100,000 patients would generate between $1 and $2 billion a year in sales, which is a lot more than the $490 million Lehman is predicting Tysabri to generate at peak sales.
Why would you deny even the possibility of BP manipulation? That's like insisting that Mutual Funds don't cheat. I'm not saying who's dirty or how much bad stuff is going on and frankly, as a LTBH player, I don't care. What I do care about is whether the company I have invested in can weather the storm -- whatever that may be. I agree that there are those that have legitimate doubts about DNDN's future. But as a good friend of mine once said, if you can think it, if you can imagine it, you can be certain that it is being done.
I don't think DNDN is out of the woods yet. If they fail to secure FDA approval the first time out -- a real possibility IMHO -- things will get dicy.
I'm quite long DNDN, very patient, watching closely for over a year now, jaded and cynical. This market is a dirty business. These days there are no guarantees of anything.
Thurly
I suppose I should finish by stating the obvious,
If the Novo case argument is correct, it suggests DNA's claim of infringement on 414 fails insofar as Iplex is not derived from direct expression.
Thurly
Thanks, I'm reading some past posts and some of the significance of the Novo case is sinking in.
What do you make of the Markman Hearing opinion where the judge comes to exactly the opposite opinion?
From north40000's court opinion transcript post #2437
B. The '414 Patent
1. Claim 1
Claim 1 provides, "A process for producing human IGF-I
comprising preparing a replicable expression vector capable of
expressing the DNA sequence encoding human IGF-I in a prokaryotic host cell, transforming a prokaryotic host cell culture with said vector to obtain a recombinant host cell, culturing said recombinant host cell culture under conditions permitting expression of said human IGF-I-encoding DNA sequence to produce human IGF-I, and recovering said human IGF-I."
a. Expression
The parties dispute whether this claim covers both fusion and
DIRECT expression of a human IGF-I-encoding DNA sequence. Their differing constructions of terms in this claim arises out of this dispute. Plaintiffs contend that claim 1 covers both.
Defendants, however, claim that claim 1 covers only DIRECT
expression, not fusion.
Defendants' expert conceded that a person of ordinary skill in
the art understands the term expression to encompass both fusion and DIRECT expression. See Gaede Dec., Ex. 5 at 79:25-80:3.
The Federal Circuit instructs that the ordinary meaning of a term governs absent an express disclaimer in the patent. See, e.g., NTP, Inc. v. Research In Motion, Ltd., 418 F.3d 1282, 1308-9 (Fed. Cir. 2005).
As Plaintiffs note, here, there is no express disclaimer. Instead, the patent itself, the specification and the
prosecution history demonstrate that the inventors used the
ordinary meaning of the term "expression."
Personally, I find the Novo decision more compelling as an argument. After years of applying and appealing, the patent office granted DNA the patent based on a carefully constructed claim: direct expression is new and therefore patentable. The careful construction of the argument suggests to me that they knew that they wouldn't be granted a patent if they were also claiming fusion expression.
Thurly
jellybean,
I know that many here have argued that DNA's patent was rejected in Europe because of prior art. The hope here, as I understand it, is that the US courts will invalidate DNA's patent for the same reason.
But DNA's patent history as described in the Novo decision suggests an argument that was developed over several years of application and appeal. In the crucible of that process, DNA finally convinced the patent office that their direct expression approach was new and, therefore, patentable.
BUT the scope of DNA's patent is limited by the specificity of their argument.
In the case you cited it reads,
<< Genentech consistently argued during prosecution that the patentable invention was a method of directly expressing human growth hormone; it never argued that the invention included cleavable fusion expression. 8 It is thus clear that claim 2 is limited to a method of directly expressing human growth hormone. The district court erred in adopting Genentech's broader reading of claim 2, which is not supported by the claim language, specification, or prosecution history of the patent. >>
My question to you and to the other legal and science brains here is, is this distinction between direct and fusion expression specifically relevant to the patent infringement arguments that have been brought against INSM? Does INSM use DNA's direct expression process or some other process to make Iplex?
I know that there have been discussions about these issues on the board. Pointers to relevant posts would be sufficient and greatly appreciated.
TIA,
Thurly
On Bloomberg: Russell Rebalancing in Progress
One of my favorite analysts. (Sorry I can't spell Jack P's last name and he's not listed as a guest on the website.)
Part of the movement in the stock market the last two days has to do with the Russell Indices re-balancing that is going on. The re-balancing affects billions of dollars in securities. This morning there was a lot of selling as institutions and hedge-funds positioned themselves for tomorrow and Friday. He expects the stocks included in the Russell Indices (and the market as a whole) to move up for the rest of the week: "I'd be really surprised if there wasn't a move up..."
As of now, we are forming a hammer of sorts in the charts. Strong rejection of the 1.40s and low 1.50s...
FWIW,
Thurly
DJ Wire re: ENDO Presentations
Insmed Presents Positive IPLEX(TM) Data At ENDO 2006
BOSTON--(BUSINESS WIRE)--June 27, 2006--
Insmed, Inc. (NASDAQ: INSM):
Results from 3 IPLEX studies demonstrate:
-- IPLEX increases growth and improves blood sugar control in
patients with severe insulin-resistance syndromes, such as
Leprechaunism and Type A syndrome (1)
-- IPLEX improves growth rate in children with severe primary
IGF-I deficiency(2)
-- IPLEX safely increases IGF-I levels in healthy adults without
causing abnormal increases in free IGF-I levels.(3)
Insmed, Inc. (NASDAQ: INSM) today announced new study results that show
that IPLEX(TM) (mecasermin rinfabate (rDNA origin) injection) is effective
in increasing growth and improving glycemic control in patients with severe
insulin-resistance syndromes, specifically Leprechaunism and Type A
syndrome.
In another clinical trial, once-daily treatment with IPLEX
significantly improved height velocity in children with severe primary
insulin growth factor-I (IGF-I) deficiencies.
A third study of the
pharmacokinetics of IPLEX in normal adults showed positive results, with
simultaneous increases in IGF-I and IGFBP-3 and without undue increases in
"free" IGF-I.
Findings of all three studies were presented this week at the
annual meeting of the Endocrine Society, ENDO 2006.
In a study showing the impact of IPLEX treatment on infants diagnosed
with Leprechaunism (or Donohue syndrome) (Abstract OR40-2), preliminary
results indicate IPLEX improved growth and glycemic (glucose) control, as
well as potentially prolonged the life of at least one patient.
Leprechaunism, the rarest and most severe insulin resistance syndrome, is
diagnosed in infancy and in some patients can result in death in the first
year of life. In this study, two patients with Leprechaunism were treated
with IPLEX. Results showed an improved height standard deviation score in
both patients (one from -3.3 pre-treatment to -2.4 with treatment and the
second from -2.8 pre-treatment to -1.8 with treatment). Additionally the
first patient achieved a reduction in HbA1c (7.6 percent pre-treatment to
6.7 percent with treatment), as well as a decrease in mean daily glucose
levels (9.4 mmol/L pre-treatment to 6.6 mmol/L with treatment), indicating
IPLEX produced a significant physiological benefit in this patient. This
patient has been on therapy for three years and both patients currently
remain on IPLEX treatment.
In the severe insulin resistance study, three adolescents with Type A
syndrome, a disease in which the patient exhibits poor glycemic control
despite conventional therapies, were evaluated on IPLEX treatment. Each
patient entered the trial with elevated glucose levels and inadequate
response to treatment with traditional therapeutic agents. Results showed
that these patients, when treated with IPLEX, demonstrated approximately a
20% average decrease in HbA1c and daily glucose levels. Patients receiving
IPLEX experienced decreased glucose excursions, reduced insulin usage, and
noticed less prominent acanthosis nigricans (dark, velvety skin patches),
which are commonly associated with severe insulin resistance. In further
evidence of drug-dependent changes, all of these improvements worsened in
each patient once IPLEX treatment was terminated.
"The preliminary results of this study suggest that IPLEX can be more
effective than conventional diabetes therapies in patients with severe
insulin resistance syndromes," said Kenneth M. Attie, M.D., Vice President,
Medical Affairs, Insmed. "We look forward to the completion of these
studies with IPLEX and continuing to evaluate its utility in diabetesrelated
disorders, particularly in those with extreme insulin resistance."
Safety and Efficacy in Children with Severe Primary IGF-I Deficiency
A second study (Abstract OR 40-1) presented at ENDO demonstrates
IPLEX's safety and efficacy in children with severe primary IGF-I
deficiency. A prospective, multicenter clinical trial of IPLEX administered
once daily showed that treatment resulted in statistically significant,
dose-dependent increases in height velocity (growth rate) with a favorable
safety profile. Average height velocity in one of the treatment groups,
treated with a dose of up to 2 mg/kg/day, increased from 2.0 cm/year pretreatment
to 8.3 cm/year during the first year of treatment. Children with
genetic and acquired forms of growth hormone (GH) insensitivity appeared to
respond equally well to treatment in this study.
IPLEX was generally well tolerated in these patients. Adverse events
included injection site reactions (including erythema, lipohypertropy, and
hair growth), hypoglycemia (generally rated as mild and asymptomatic),
headache, and tonsillar/adenoid hypertrophy.
IPLEX Pharmacokinetics in Normal Adults Presented
Results from a pharmacokinetic study of IPLEX, presented during 2
poster presentations, demonstrate that IPLEX has unique, positive
properties. The first poster (P1-191) presented the pharmacokinetic results
of single-dose administration of the drug to 28 healthy adult volunteers.
The investigators concluded that due to the gradual absorption and
elimination of IPLEX in the bloodstream, sustained increases in levels of
IGF-I and IGFBP-3 are achieved lasting more than 24 hours. These data
indicate that the drug can be administered once-daily or, in certain
patient populations, possibly less frequently, such as every other day.
IPLEX was well tolerated during the study.
A second poster from this study (P1-192) examined the levels of free
IGF-I in healthy adult volunteers after administration of IPLEX. Under
normal circumstances, less than 2 percent of IGF-I circulates as the free
biologically active form because of a complex physiology that keeps it
bound to other proteins, principally IGFBP-3 and ALS. The IPLEX complex was
designed to limit the amount of free IGF-I associated with replacement
therapy, thus maintaining a physiological balance of IGF-I with IGFBP-3.
Results of this study conclude the mean percent of free IGF-I did not
exceed 1 percent at any time during the 72-hour sampling period, thus
avoiding supra-physiologic levels of free IGF-I.
"IPLEX was designed to provide IGF-I in a stable complex with its
natural binding protein, and thus mimic what occurs naturally in human
circulation," said Attie. "In the pharmacokinetic study presented at ENDO,
we demonstrated that the drug limits the excursions of free IGF-I levels by
providing a gradual absorption of the apparently intact complex. The
pharmacokinetics of this drug make it an ideal treatment for children with
severe primary IGFD and, in the future, other patient populations that
might benefit from once daily IGF-I replacement."
(1)ENDO 2006 Abstract OR40-2 - rhIGF-1/rhIGFBP-3 Treatment of Patients
with Severe Insulin Resistance Syndromes: Preliminary Data.
(2)ENDO 2006 Abstract OR40-1 - Once Daily rhIGF-1/rhIGFBP-3 Treatment
Improves Growth in Children with Severe Primary IGF-I Deficiency: Results
of a Multicenter Clinical Trial
(3)ENDO 2006 Abstract P1-192 - Subcutaneous Administration of rhIGF-
1/rhIGFBP-3 in Healthy Adult Volunteers Does Not Result in
Supraphysiological Concentrations of Free IGF-I.
Why do you blame the company? There are a lot of forces out there, the company is just one -- and for now, not the strongest one. You're an investor? Get real. This is smallcap biotech. Given the present circumstances, there is nothing unusual in the way this small biotech is behaving at this point. If you can't take it, you shouldn't invest here. Nobody forced you to put your money on the table.
Thurly
I've added 20K shares this week. I look at it as a gift.
You have to give yourself room to weather any storm -- and take advantage of the bad storms, if possible.
Thurly
If INSM can go after TRCA for legal costs and, given their cash burn, TRCA finds after the various court actions and associated costs that they don't have the money to pay the fees (and, possibly, penalties), can INSM go after DNA as well for redress of costs and penalties?
Thurly