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during the last conference call, INSM said that they are getting cost reimbursed...the question is whether the cost include the burning rate or if the cost is just the variable cost of producing IPLEX. Anyways, I think that it's not unreasonable to estimate the reimbursements at anywhere between 75K-100K per patient, which puts 50 patients at 3.75Million - 5Million, already higher than INSM's projection of 3 Million a year for ALS. I wouldn't be surprised to see the number jump to 100+ patients by June of this year if Italy allowed the program to expand freely.
question, I am confused as heck!
During the cc, Allan said that HARS and MMD are both very small trials of 12-24 people. And they have to design a Phase II trial with placebo to get Phase III enabling results. But the following PRs are dated 2 years ago that claimed initiation of Phase II already. What is going on!!!!!!!!!!!!!
are those studies real Phase II or not??? what's messed up? CEO Allan, or the PRs lying??
CAN ANYONE ANSWER THOSE QUESTIONS?
Insmed Initiates Phase II HIV-Associated Lipodystrophy Trial With Somatokine(R)
RICHMOND, Va., April 20, 2005 /PRNewswire-FirstCall via COMTEX/ -- Insmed Incorporated (Nasdaq: INSM) today announced that it has initiated a Phase II clinical trial examining the therapeutic benefit of treating HIV-Associated Lipodystrophy with SomatoKine(R), the Company's proprietary once daily IGF-I therapy.
U. of Rochester Initiates Phase 2 Clinical Trial of Insmed's iPlex for the Treatment of Myotonic Muscular Dystrophy; Trial Funded by NIH and MDA Grants
RICHMOND, Va. & ROCHESTER, N.Y. & TUCSON, Ariz., Jan 04, 2006 (BUSINESS WIRE) -- -- Insmed Incorporated (NASDAQ: INSM), a Richmond, Va., biotechnology company, the University of Rochester School of Medicine, and the Muscular Dystrophy Association (MDA) announced today the initiation of a Phase 2 clinical study investigating the use of iPlex(TM) (mecasermin rinfabate (rDNA origin) injection), a once-daily IGF-1 therapy, for the treatment of myotonic muscular dystrophy (MMD), the most common form of adult muscular dystrophy.
Insmed Initiates Phase II Trial With SomatoKine(R) in Type A Extreme Insulin Resistance
RICHMOND, Va., April 26, 2005 /PRNewswire-FirstCall via COMTEX/ -- Insmed Incorporated (Nasdaq: INSM) today announced that it has initiated a Phase II clinical trial examining the therapeutic benefit of treating Type A Extreme Insulin Resistance with SomatoKine(R), the Company's proprietary once daily IGF-I therapy.
The clinical trial, led by Principal Investigator Professor David Dunger, University of Cambridge, Cambridge, U.K., is a Phase II, open-label, dose-ranging study designed to evaluate the safety and efficacy of SomatoKine for 16 weeks in 10 patients with Type A Extreme Insulin Resistance. To qualify for inclusion in the study, patients must be between 10-65 years of age and have a diagnosis of Type A insulin resistance. The primary efficacy endpoints of the trial are improvement in glycemic control, improvement in insulin sensitivity, reduction in hemoglobin A1c and improvement in body composition.
A Letter to ALL CURRENT INSM Shareholders:
After hearing the conference call, I was really surprised the CEO Allan gave away the short stature market based on pre Phase II data.(he probably knows how good the data is) but his trade off is definitely too early IMHO.
What I am writing here is that we, as a collection of shareholders, write to the INSM management and actively convey the following ideas:
1. INSM management should contact Tercica and offer to produce Increlex for Tercica at a mutually beneficial rate. Currently Tercica has the production of Increlex outsourced, and I believe that INSM's boulder facility will have a better rate of successful production. This is mutually beneficial to both as Tercica will have higher rate of success, and INSM can recoup some of the burn of running that facility.
2. INSM management should offer Tercica a license to selling Iplex for the shortstature market along with Increlex. Yes, Tercica will not agree to it. Then INSM management should play hard ball, and DOUBLE the cost for Iplex and still sell it to the kids. Since Iplex is FDA approved, IPLEX can still be sold at the hard ball rate of 40% royalty. The agreement DOES NOT ban selling of IPLEX should the doctors prescribe, it only bans Marketing.
3. INSM management should quickly update the website, as of right now is what I consider "de-faced". Since it can no longer MARKET shortstature, the website should reflect the values of pre Phase II trials of MMD, HARS, and the Italy deal of ALS!
4. The board of directors should consider a pay CUT for CEO Allan, for his abysmal performance of all those years, and agree to restore his pay on the day a cash infusion from DNA or Tercica is established based on favorable "Phase III ENABLING" data for either HARS or MMD.
Thanks,
Can someone with the resources draft up a formal letter of petition?
Or do you think I am way off here?
the CEO should go...PERIOD!
For someone sucking up 500K a year on salary alone, his performance during the conference call makes me question if he needs some incredlex for brain function improvements...
IPLEX can still be given to shortstature patients who specifically request IPLEX at 40% royalty. Yes the royalty is high, but it's not exactly off the market.
IPLEX can be given to ALS, and other non-TRCA indications at 4% royalty.
This is from the TRCA conference call Q&A
I don't know...and I don't care anymore because the lawsuit is over
What I do care is that Tercica's halt is over, and INSM's isn't. Makes me wonder if INSM's got more news coming.....during cc. :)
RTN, first of all, thanks for all your work...I been following INSM for quite a while know, and have to agree that it's argurably the single most undervalued security on the market today.
The deal itself does NOT look positive as INSM does seem to have given up the short stature. As you have said, hopefully Allan isn't STUPID. Can't wait till the conference call, they better give us some data!!!!!
STUPID DATA come out already.....
zake1....i am saying that Genentech/Tercica has RESERVED the right to be 50/50 partners is because of this:
a binary outcome:
if INSM's pipeline is successful to the point where half of the development cost is less than 4% of potential royalty. It's simple math...so far it's 400M cost. Another two years...so probably 500M cost. half of that is 250M. when (50% profit - 4% of potential royalty) exceed 250M, Genentech will exercise the opt-in, which is possible. assume a 30% post royalty margin, 50% profit is about 15% revenue. 15-4 =....about 10% revenue so when expected revenue from IPLEX exceed 2.5B, genentech will choose to opt in
As ALS is estimated by my previous post to be AT LEAST 2.5B or CYTR wouldn't have received 24.5Million for 1% royalty.
if INSM's pipeline fail(unlikely, but we are discussing a binary outcome) Genentech wouldn't care about 4% royalty as it didn't have to come up with dev cost.
either way, DNA/TERCICA are more of a winner than if INSM fought on.
What is it for INSM? NO BK...and probably doubling of stock price.(which INSM could potentially be without this deal)
I am also going to read the terms closely to see if the agreement can be revoked later on. I am thinking if after 2010, INSM came up with a way to overcome 414 patent, then INSM should revoke this stupid deal as it's no longer necessary.
As discussed earlier, I don't, repeat, DON't view this deal being the best INSM could come up with. (Of course, INSM will probably open above $2 in the morning) I would rather see a 10% royalty to all indications rather than 4% to shut out DNA/TRCA from opt-in, and keep Iplex on the shortstature market.
Reasons:
1. We did give up short stature to TRCA. (giving up certainty.) of course it's peanuts compared to others, but there is also an uncertainly surrounding other indications as I have mentioned in the other posts. Essentially, DNA/TRCA put INSM back to a PII company with much larger potentials.
2. The opt-in options to both DNA and TRCA is like saying: DNA and Tercica each Reserves the right to merge with INSM as equal partners, the discretion is not INSM's.
Positives that come out of this:
3. no damages, and 4% royalty...
Overall, better than no deal, but on a scale of 1-10, 10 being the greatest deal INSM can come up with, it's between 4-6 in my book.
quick calc of how much ALS alone is worth:
according to CYTR, they received 24.5Million for 1% revenue. I mean that means the worst conservative estimate of total global ALS revenue is almost 2.5B. Assume that CYTR's drug will succeed, and assume that IPLEX gets half of the ALS market(sharing it with CYTR, that means there is 1.25B minimum revenue from ALS alone. Then further assume a 30% margin, that's 400Million +, discount it 20%, ALS alone is worth 300Million + market cap!!!
with regards to ALS, Italy's request for IPlex is pretty encouraging. What are your opinions regarding the difference of effectiveness of CYTR's Arimoclomol vs INSM's IPLEX?
Yes, IPLEX for ALS, MMD, HARS is a much bigger potential market. I won't give up the certain short stature market to Tercica for a uncertain larger ALS market(MMD, HARS,etc too), which will have arimoclomol as a competitor(ALS), Serono(HARS), and other company whose name i forgot(HARS). Not sure any company is working on MMD though.
All i can is when this deal is done and public, INSM OWES its shareholders of its PII data on all ALS, MMD, HARS!!!!!!!!!!!!!!!
having said all that...yes any deal(that's not giving up the entire short stature to Tercica) is better than our current situation. It's time to get over it and let the case be closed.
rod: with all due respect, I believe that what you thought would be acceptable to INSM is not quite reasonable to others:
"Give up short stature in the US, grant Tercica rights in EU for short stature if Insmed gets MA first and Insmed gets manufacturing rights to Iplex. This would give Tercica its stated market in US and preserve the Ipsen deal and Insmed could pursue the larger indications in the US and all indications worldwide."
There are several points:
1. We all know IPLEX is superior(regardless to what DNA lawyers say) than Increlex. For the simple fact of one injection, public interest will be harmed if INSMED just "gives up" short stature to Tercica in the US. Then "gives up" EU even if MA is granted to INSM first. This does NOT make any sense.
2. We don't know the data for other indications. Yes INSM would know the quality of data, the insiders would know, but we don't know. So for you to assume that the data is good enough that INSM can instantly dump an approved indication to its competitor for return of immunity of other indications is not founded.(I mean if a deal like that is to occur, what is it to prevent a plunge in INSM's market cap pending other indication approval by FDA? current ALS, MMD, are all off-label usage, we are basically back to a Phase II company again)
3. We know that two of the patents expire in 2010. the manufacturing patent is being almost worked around by 3 ways: Cephalon, the plantation method INSM is developing, and another contract I forgot its name. So INSM is giving up an entire market to its competitor(in US and voluntarily give up EU for shortstature) for what? 3 years of so called possible injunction and royalties? I mean INSM can survive on 20% royalties for goodness sakes.
for those reasons, I don't believe such a deal is favorable to INSM at all...it's Tercica's dream deal though...they will dominate the market for short stature in US and EU and the world. We all know IGF-1 alone is not good for ALS, MMD, etc due to hypoglycemia. And INSM is back to Phase II with an approved shortstature drug that can't be used except for off-label?
The merger, buyout issues speculated on Yahoo MB are possible:
1. merger: INSM with Tercica is favorable to both, the only question is the merger stock ratio. 2:1 is low balling INSM, 1:1 is pissing off Tercica. INSM gets Tercica's cash and Ipsen's cash infusion, Tercica gets INSM's pipeline. Genentech gets royalties as defined by Tercica's contract. Longs interested in IGFBP3 pure play can still be in a relatively small co
2. buyout: Tercica can't afford to buy INSM straight. So there is possibly of DNA buying INSM and licensing shortstature back to Tercica. It's similar to what you discussed. DNA then gets the rest of the pipeline.
good thinking...i agree 2
http://www.dailytech.com/article.aspx?newsid=6298
if you don't know the significance of this, you haven't done enough DD.
tip: this is one of Judge Wilken's cases where she issued a stayed injunction pending appeal...against SONY...look where it is now
oh to add...if the judge is an idiot and ordered the injunction based on 151 only, after she denies JMOL and IC on the 151, the order of injunction is probably going to be stayed pending apeal, which typically takes about 1-2 years. If INSM is any good, it will prolong the appeals process to as long as possible, which say 2 years of appeals. That means if the worst case comes, INSM fail on appeals too, it's already in 2009. Injunction only works for one year, and royalty for the equitable remuneration kicks in for 414, and shouldn't be more than 5% by any measures. Also there is a chance that INSM might be able to finish another method of manufacture by then....that's 2 years from now...it's possible to make all 3 patents irrelevant by 2010.
as always, top notch work from INSM lawyers.
1. As we have all pointed out, 35 USC 154c, WILL apply to 414 and 287, which means, no damages, no lawyer fees, and no INJUNCTION can result from 414 and 287. can't be clearer than this! so the 7.5 Million damage will be changed....in my opinion to 2.5Million for only 1 infringement rather than 3. As to the royalty of 15% to 20%, i don't see any changes...because of the equitable remuneration clause of 154c for 414 and 287 as royalty is a good form of equitable remuneration.
2. No subject matter jurisdiction....this one IMHO....is not as clear cut as the URAA 35 USC 154c argument.
3. IMHO, this case now rest on the motino for JMOL and IC ruling on 151. Public interest favor INSM on injunction. JMOL on 414 on the issue of invalidity and non-enablement is just icing on the cake now because 414 and 287 don't represent injunctive threat.
Both 151 and 287 expire(with the URAA 17 year from issuance extension) in 2010. and no injunction can occur for the 414 and 287. So the worst case, the judge is an idiot and issues injunction based on infringement of 151, the order can only be carried for 3 years. INSM can survive 3 years. After which, only 141's equitable remuneration clause works. (which means probably 1-5% royalty or less and certainly no law suits)
Given the current situation, I do believe that INSM do NEED to release some trial data on MMD and other trials to further demonstrate the case with "Public interest" I believe a takeover offer by any of the following companies will be favorable: Genentech, Pfizer, Novo Nordisk. A merger with Tercica is also better than the current situation, but I believe that there is too much bad blood already. I for one would rather die to see INSM merge with Tercica, and sure love to see TRCA become TRCA.OB someday within 5 years.
where is defendant's opposition to plantiff's opposition to defendant's opposition of permanent injunction document? wah...what a mouthful.
no kidding...all liars..even the CEO of TRCA...btw, what's his name? Chip or JohN? John is the name they used on the website, but Chip is what they called him on the CC?
lol...potato chip.......that's what I think of when I hear the name "Chip"
yes, they did switch the numbers on 287. To make it look like URAA doesn't apply. They also ignore the fact that 414 is also filed before URAA, therefore its extension is assumed.... Those genentech laywers are using freaking lies now....to make their argument look better in front of unsuspecting judge.
I found the Genentech's reply a word-play, but man, Genentech's lawyers are good with words. Almost fooled me too...Hopefully INSM's lawyers can catch the following logical fallacy I caught regarding the URAA argument:
background:
35 USC 154
(c) CONTINUATION.-
(1) DETERMINATION.-The term of a patent that is in force on or that results from an application filed before the date that is 6 months after the date of the enactment of the Uruguay Round Agreements Act shall be the greater of the 20-year term as provided in subsection (a), or 17 years from grant, subject to any terminal disclaimers.
(2) REMEDIES.-The remedies of sections 283, 284, and 285 of this title shall not apply to acts which -
(A) were commenced or for which substantial investment was made before the date that is 6 months after the date of the enactment of the Uruguay Round Agreements Act; and
(B) became infringing by reason of paragraph (1).
(3) REMUNERATION.-The acts referred to in paragraph (2) may be continued only upon the payment of an equitable remuneration to the patentee that is determined in an action brought under chapter 28 and chapter 29 (other than those provisions excluded by paragraph (2)) of this title.
And this is Genentech's reply:
Specifically, for
1
“patents issued after June 8, 1995 . . . there is no delta period” even though based on an
2
application filed before June 8, 1995. Merck & Co., Inc. v. Kessler, 80 F.3d 1543, 1552 (Fed. Cir.
3
1996). Insmed addresses only the ‘414 and ‘287 Patents. The ‘414 Patent did not issue until
4
December 8, 2001. As for the ‘287 Patent, there is no delta period because its term was not
5
extended by the URAA; its pre-URAA expiration date (2010) is later than its post-URAA
6
expiration date (2008). Accordingly, the URAA is not relevant to the asserted patents and their
7
enforceability.
My thoughts and logical fallacy lies in Genentech's calculation of theoretical "delta period":
1. 154c letter of the law says that it's the filing, I repeat, the filing, of the patent application that creates the delta period, not the issuance of patent causing the lack of delta period. The case Genentech pointed out Merck vs Kessler, the case were judge said the clause "even based on an applicatioin filed before 1995" is not consistent with 35 USC 154. It's not an issue with Merck vs Kessler because the filing and issuance dates are close in that case, and would not have mattered. In this case the 414 patent was filed in 1983, of which if it wasn't for the URAA, would have expired in 2003. The issuance date and granting of the 17 years after issuance is already taken URAA(greater of 20 years after filing, or 17 years after issuance) into consideration and have had the extension due to it.
2 Genentech's response of URAA for 287 is very clever word play!!!! I almost got fooled by it. Notice that it created a negative "delta period" by saying that pre-URAA is 2010 and post-URAA is 2008, so the lack of URAA delta period exclude URAA rules. This is to confuse the judge by math, and it's illogical because post URAA is still 2010 by taken into the extension of the "greater of 20 years after filing and 17 years after issuance" Again, it's the filing date that causes the URAA extension, not the issuance date.
Good grief...Genentech's lawyers are good....with words that is...hopefully INSM sees what I see. I might forward this to INSM's lawyer myself..
Thanks,
ThomasS, you obviously haven't read the 1060 motion carefully. There will be no damage(including royalties) awarded for 414 and 287 due to 35 USC 154. and royalties awarded for 151, if no IC is found, is only up to 2010.!!!
i have a question:
§ 154(c)(1),
provides for a term which is the greater of 20 years from filing or 17 years from issuance. But when
this extension is in effect, §§ 283 (injunction), 284(damages), and 285(attorney fees) of t
does the 284(damages) section include Royalty payments?
favorite argument in Bunsow response:
The application that became the ’414 patent was filed in June 1983. Consequently, under the
new patent term, it should have expired in 2003. For a patent filed prior to 1996, however, § 154(c)(1),
provides for a term which is the greater of 20 years from filing or 17 years from issuance. But when
this extension is in effect, §§ 283 (injunction), 284(damages), and 285(attorney fees) of the patent
statute do not apply to one who commenced or made substantial investment in the infringing acts prior
to 1996. Id. at 154(c)(2). Insmed and its predecessors are within this exception and cannot be enjoined
for infringement of the ’414 patent. (TT 1756-1763, 1957.)
The same limiting provision will apply to the ’287 patent after March 22, 2008— little more
than a year from now. When the one year notice provision of 21 U.S.C. § 360bb(b) is taken into
5
account, neither an injunction nor damages are available for the ’414 and ’287 patents. (Id.)
really nice document. I read it three times already:
to Summarize:
1. There are still issues with the patents that JMOL(Judgment as a matter of law) could reverse the jury verdict
2. Motion for Inequitable Conduct issue was simply renewed
3. Superb arguments for the four tests for NO INJUNCTION
4. Stay of Injunction, if granted, till Apeals
5. Good arguments for reduction of damages, and no enhanced damage, no interest payments
Overall, superb work I must say. Best written document I have read so far in all the court documents. Good Job Mr. Bunsow. LONG INSM! screw patent troll TRCA.
Also INSM stated earlier that their ALS named patient program brought in about $100K/patient/year.
This would give a max. gross revenue of $20MM for 2007 (most probably less due to ramp-up times).
Seemingly Mr.Market agrees. Since the shareprice jumped about 20-30 cents given INSMs 100MM shares.
Let's first assume that your revenue estimate for ALS from Italy is correct, the question is this: since when is 20MM annual revenue only worth 20Million market cap? Last time I checked, biotechs are valued at 4-5 times the potential revenue from indications. So 20Million additional ALS revenue from Italy is worth 80Million market cap...(minus say 20% royalty...that's still 55M market cap)
several differences I can see in the Abbott case:
1. Both company can and are producing the same product. TRCA is IGF-1 .. INSM is IGF1-BP3
2. innogenetics can produce the same product. TRCA doesn't have the knowhow to produce BP3 complexed with IGF1
3. ABT is the infringer. The bigger company trying to screw the smaller company. INSM is the infringer in this case...same idea that bigger company always try to screw the smaller company for market share
oh another issue:
If Tercica argues that for each IPLEX sale, Tercica wants INSMED to pay its profit. Since Tercica is flushing all its increlex down its toilets, I believe that the variable cost of producing increlex is greater than the revenue generated by increlex, which means that for each sale of increlex, Tercica is losing money, which means that profit for inrelex is negative.
Hey, if Tercica wants a negative profit to be paid for each IPLEX sale...INSM can get a check from Tercica for each Iplex sold because Tercica didn't lose money on that shot of increlex it didn't produce :)
I would like to offer some thoughts regarding Tercica's motion for permanent injunction document.
Upon reading 1021 motion for permanent injunction as submitted by DNA/TRCA's lawyers, I think there are quite a few illogical statements in there.
1. page 16, lines 11-17. " (Roberts, C.J. concurring). For decades, where patent infringement is by a direct competitor, an injunction generally has issued." The concurring statements by Roberts, and Kennedy are merely concurring opinions and they are by definition not legally binding. Tercica's lawyers are desperate to argue using concurring opinions by Roberts. LOL. I believe Kennedy also stated in his non-legally binding opinion regarding the development of an industry of using patents as leverage of higher royalty payments or injunction? That was never mentioned...but it's irrelevant.
Most of the cases TRCA uses are pre-EBAY, any historic examples of injunction is irrelevant. We should only evaluate arguments regarding the four independent tests that would determine injunctive relief:
Out of the four tests, I think DNA/TRCA's arguments are most believable at best on the first test, regarding irreparable harm. The arguments for the rest of the three tests are illogical and below is the reason why:
2. For the second test of sufficient monetary remedies to adaquatedly compensate plaintiff's irreparable injury. First, constitutional right to exclusitivity has not be relevant in cases after the EBAY vs MercExchange case, it certainly is irrelevant to prove inadequate compensation Second I quote the argument from page 19 lines 26-28. "As Dr Hausman analysis shows, Tercica must at least receive the amount of profits it loses due to IPLEX sales" So they contradict themselves by saying there is a maximum level of monetary damage that can adequately compensate Tercica. Although if Tercicia is to receive the profit it loses on every IPLEX sale, it would not satisfy the balance of hardship cause of test three. Third, TRCA aruges that "Even then, the value of being sole provider in a market is greater than simple profits" reveals its intention of maintaining a monopoly in the market. Fourth, arguing about INSM's stock price as evidence of inability to pay royalty is irrelevant. They failed to realize that INSM's stock price is a function of this stupid injunction motion and the added short interests from hedge fund. From INSM's view, since the potential market is CLOSED, even TRCA mentions 6000 patients. The damage is QUANTIFIABLE.
Third Test: Balance of Hardship
Here TRCA uses circular logic of irreparable injury, and willful infringement as basis for balance of hardships. Irreprable injury is irrelevant in this test, because each test is INDEPENDENT. You cannot argue balance of hardship using irreprable injury which is the first test. Willful infringement is also irrelevant as 151 is still undergoing inequitable conduct. In fact, TRCA's argument that to fairly compensate, INSM must pay Tercica's loss of profit for each IPLEX patient is a case against them in this test. Assumption of monopolitic pricing is inbalance of hardship, it makes tercica exist as if there is no competition. I propose that INSM's lawyers should use this test to argue for favorable royalty to balance the hardships between INSM/TRCA as both LICENSEES to Genentech.
Fourth test: Public Interest
TRCA's argument that public interest is served by injunction is totally circular.
Argument regarding refusal of compulsory licensing.
Since when is a compulsory licensing meant to replace 100% of profit lost to the plantiff?
Some outstanding issues:
1. IC regarding 151, if found unenforceable in court, would be grounds to strike out all mentions of willful infringement.
2. The differenciation of Tercica's right as a LICENSEE to Genentech's patents and the calculation of damages to the license holder. To rephrase, since Genentech is the owner of the patents in question, all irreparable harm and damages should only include Genentech, not Tercica as a licensee. Of course, in calculating the damages done to Genetech, Tercica's payments to Genentech is part of it. All I am trying to say is that adequate compensation is to Genentech only. A comulsory license, if granted to INSM by the court, should reflect equity in its terms of royalty to make INSM a second licensee of genentech and be put in the same terms as Tercica.
that was exactly my point. Jury brought in the infringement decision before the court decided on legality of the patent itself via IC.
I mean, for goodness sakes, this whole case is a patent case. Wouldn't the first priority to establish enforceability first? The way it's done right now is assume the 151 is valid and ENFORCEABLE, let the jury find if INSM infringed or not. That assumption of enforaceability should be denied and motion for IC and evidence heard and decided by court First. I read the motion for IC by INSM, and the arguments regarding the MAACK and SOMNER papers predate the 151 patent. Even though DNA proved to some degree that it was reduced to practice prior to the 2 papers, the failure to include the existence of the 2 papers which Dr Clark received and failure to include trial 5 data alone is reason enough for IC regardless if it was reduced to practice. That was my point.
I have done some research on Wilken. Some facts:
1. She issued a stay for injunction against SONY for the PS2 controller pending appeal, but that was pre-EBAY.
2. She's quiet liberal.
3. The chosen date for Feb 16, 2007 for the decision is kind of weird.. Seems like she's waiting for EMEA action(Jan 22 for 180 day timelimit, then Feb around the time EMEA approves) before she decides. See if EMEA approves IPLEX instead of increlex, then she MIGHT feel better about injunction in the United States leaving EU for INSM...so it's a split. US for TRCA till 2018. EU for INSM for 10 years.... i am just speculating for the dates.
4. Having to decide IC and Injunction on the same day will have 2 different interpretations. First, either Wilken has already made up her mind to go against INSM on IC to validate the jury's damage awards, then decide on injunction based on the four tests from EBAY case. Or Secondly, i am speculating that she's leaving a backdoor for INSM to mistrial the whole thing because she realizes that she made a mistake not doing IC first, which will be chewed on at the appeals court, which might throw 151 out of the window anyways, so she left this backdoor for INSM to get out to look like it's a mistrial by intentionally not deciding on IC issue. That way, she is forcing a deal amonst DNA/TRCA/INSM. I am forseeing DNA purchasing INSM to get the BP3 patents then licensing to TRCA and keep the other indications in Phase II all to DNA itself. Again, I am not a lawyer, I am a speculator.
smallinvestor = tshen_83 LOL...i just freaking revealed my identity...darn...stupid me...the question still stands....with a good reason.. Wilken better answer that question.
can anyone answer this question i have? Please correct me if I am wrong, i have read and reread all court documents:
The issue of inequitable conduct regarding patent 151 has not been decided and will be scheduled to be decided on Feb 16, 2007. But the Jury has already deliberated, and set royalty provisions on past sales based on willful infringement of 151 patent without a decision by the judge first whether or not 151 has IC issues. And DNA/TRCA filed motion for injunction based on Jury's findings and the decision on injunction is to be heard also on the same date.
Now answer these questions I don't understand:
Is the judge insane for allowing jury delibration on patent infringement when IC issues regarding one of the willfully infringed patents ie 151 are still outstanding?
If DNA/TRCA's motion for injunction is based on Jury's finding of infringement(let's not argue for the 4 tests now), and Jury's finding of willful infringement is based on the fact that 151 is valid and subsequently awarded big damages of 20% royalty as guideline, and IC could change that. How can the motion for injunction and motion for inequitable conduct be decided on the same day when motion for injunction relies on a decision of motion for IC at a distance?
I have heard that if the judge decides IC for 151, this lawsuit could lead to potential mistrial. However, given what I just said, the judge allowed for Jury deliberation and award damages without first decide on IC. Shouldn't that fact alone qualify as basis for mistrial?
Thanks
those researchers are in the same bin as the researchers who "research" that playing violent games cause violence, or researchers who "research" that eating fatty foods will cause obesity or "research" that drinking induces more automobile accidents, or "research" that globe is warming. Yet they don't offer crap toward solutions besides.."don't do it" lol
i think what's going on is this:
Those studies are posted by institutions to scare individual to loosen some shares.
The way i look at things: any drug that encourages growth is bound to have some degrees of increased cancer risk. I mean growth is the division of cells. Any increased rate of growth might increase risk of cancer cell.
The question is the safety profile of such growth. The study has shown that IPEX is safer for sure. There are studies out there that shows that TRCA has more cancer cell growth using their increlex too.
Shame on the institutions for playing the FEAR game this way...Shame on them....Fock them. And Fock the researchers.
yeah people are trading those shares at 10K lots...but that doesn't mean much, because it's only 9000 dollar lots. Even small investors are able to do it now. Institutions are definitely buying up. You can see it....Every morning, individuals are pushing price up in the open, and the institutions are mad and push the price down again intraday so they can load up more shares before Feb. I wish i had more cash to buy at this price levels.
i sound reasonable...but the current reality in the market isn't. The current 90 cents price on INSM is pricing almost a 50% chance of injunction, which i think is highly unlikely due to the test "in the interest of the public", especially for other indictions in the pipeline. It also prices in a possibility of stock dilution of probably 50 Million more shares at around $1.00 for 50 Million more cash, which lasts INSM another year or so. The best course for INSM, as I have discussed on many posts, is to sell to DNA for 3-4 bux, or find a EU partner soon. TRCA got a 80Million cash infusion from their partners as soon as they get MAA approval. (but they won't get it till probably July 2007)
this is a highly speculative play. If INSM gets injunction decision on Feb 16, 2007, the Stock will be 50-60 cents. If INSM doesn't get injunction and royalty stays below 15% as ordered by the judge, INSM goes to 2.00. If INSM gets a buy out offer, probably $3 or $4. Probably from Genentech(DNA) or a 2 for 1 merger offer from TRCA(which i think is highly unlikely), which will value the company around $2.50 - $2.75. Right now it will hover around 1.00 for a month unless a partnership for Europe is announced with cash infusion or favorable Phase II results for other indications.
the big picture is that IPLEX is a better drug than increlex. If two companies sell to the same market, the superior drug wins. Simple market demand for the better drug.
The question is if INSM will find financial support to survive the lawsuits and cash burn. One way to solve the problem is to sell to DNA! I am sure at this depressed price, DNA is interested.
Several thoughts:
TO TRCA, INSM isn't worth 3 dollars or 300Million. Heck TRCA is less than 300M themselves. So I agree with you that TRCA won't be paying $3 for INSM. The question is how much would TRCA pay even if they are interested? I have seen speculation for 1TRCA for 2INSM merger. that will value INSM at 2.75 a share. Then the arbitrage people will come in and short TRCA to $4.00 a share because a combined TRCA/INSM company is still targetting the same short stature market. That means in the end INSM people get $2 for all their trouble for 200M valuation.
To DNA, INSM is worth 300Million at least. There is no royalty payment, no injuction if DNA bought them. and DNA will kill off TRCA for their stupidity.