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Walldiver: maybe update the main info board
with one of the ivillage summaries?
might be nice addition to the primer
No idea where Coin is people, hope he is well though
His earlier time and posts gave a great insight in insmed for many new people...
So lets hope he shows up again some time to enjoy the fruits of his work... wont be too long for insmed now, hardest times behind us
ANd you have opinion on INSM-18 as well?
Since coin has been away so long, i'll try to update the main boards this weekend
Pretial motions After trading today,
so there could be news on monday
Anyone know what this legal text is?
what is the text they refer to?
does that txt do include injunction?
"Plaintiffs do not object to jury instructions §§ 1.1-1.12, §§ 1.13-2.2, and §§ 3.1-4.3 from
the Ninth Circuit Instructions, but request that the Court (i) replace § 1.2 with the modified
Northern District Of California Model Patent Jury Instructions (hereafter, ND Cal Patent
Instructions) § A.1, (ii) omit § 1.14, §1.16, §3.4 and § 3.8 because they are not relevant to this
case, and (iii) add §§ 2.4, 2.6, 2.10 (if applicable), 2.13, and 4.4, from the Ninth Circuit
Instructions."
Questions:
A) hmmm googled it, got a 2004 brief.. is that sitll current?
B) damages are discussed in section 5.*
since plaintiff is not referring to those it is unlikely that the word injunction will show in the jury instructions?
http://tinyurl.com/prkny
Reports and trial motion download link
Badongo.com seems to have wiped my older one;s
so get all here now, no description there, just pure file downloading
Download it at
http://www.xs4all.nl/~surg3on
Thanks!will check it asap
good you mentioned it, the gmail i check more frequently
will make so soon
Download it at
http://www.xs4all.nl/~surg3on
trca's earlier rreply is not on the webpage i posted, since i dont have that pdf, just some unconfirmed summaries
the earlier insmed one should be there as well
TRial will last 11 planned days
http://www.cand.uscourts.gov/cand/calendar.nsf/572d47d88520f842882566a2007f2b59/1dccb80c9d1ab8708825...
08:30 AM
(r)C-04-5429 Genentech v. Insmed
Jury trial (11 days)
The pdf is downloadable now at the address:
http://www.xs4all.nl/~surg3on
Hmm..seems this one no more.. hmm/.//migh re-upload them at some time there http://stockpick.badongo.com
PS Rod, thx and sorry i never usually check my yahoo one, it was there...only checked my gmail accounts
Rod: could you retry email? did not receive one..
added a public one now for such occasion
Dew, i am aware that you are sceptical of DNDN, and i disagree with you on that view
However even you should be aware that pre decision time will be on a substantial higher level than the current price
A large portion of those shorts will not make a 100% gamble, where thye allready have substantial gains on their play
momentum players , longs and covering shorts will still be aiming for the same shares
so still money to be made there
time to bottomfish presents itself on multiple occasions
I fully intend to sit it out through any FDA decision btw
walldiver: your view on this post from Ivillage?
Msg: 9006 of 9045 10/22/2006 2:13:04 PM Recs: 42 Sentiment: Not Disclosed
By: jerzee Send PM Profile Ignore Recommend Add To Favorites
psssst ....
4:00AM Sunday and bored .... hit Dunkin' Donuts .... flipped the coin - heads .... back to the office ...tails ...road trip ....
Tails is was so we metaled the petal and schlepped on down to Hanover for a look see.
Fresh paint on the road way entrance ....fresh painted lines in the lot ..... nice new sign Dendreon ..."Targeting Cancer ....."
Snapped a few pics .... no Ansel Adams this one .... and it's tuff trying to shoot through glass with the Brownie Box .... but maybe these'll give you some idea ......
http://pg.photos.yahoo.com/ph/jerzee_jammer/slideshow_end?.dir=/af4fre2&.src=ph
While poking around, a tired looking guard (sans uniform) drove up in a very tired looking vehicle .....
"You a contractor?"
"Nope ...justa curious 'vestor."
"Oh"
"So this is it huh?" I asked begnignly "How do we think we're doin'?"
"Scientists have been shuffling in and out day and night for a while now. Arlee (or Orlee ...or maybe Andy - as in Scherer??? - couldn't make it out ... thick Indus Valleyish dialect made it a tuff listen) has been putting in a lot of time – even Saturdays."
Then - outta nowhere - came the bomb .......
"The FDA was here last week."
"FDA?"
"Yeah. They've been here a few times."
"Are they overseeing the run on a sample?"
"They've been doing that. It all happens in stages, you know."
I didn't but said "yuppp" anyway. "So they have run a sample?"
"Yeah. That's why they were here last week. It's done."
"Done? You mean they have the manufactured sample?"
"That's what they say ......"
With that and before I could ask him if I could buy him breakfast ....or a new car .... he said he had to check on some other properties.
OK – before we all get too excited ......let’s consider the source and remind ourselves this is a security guard.
What does he know?
Also let's consider this reporter. By now most here should know .... he doesn't know!
So where doe all this leave us?
That's a question for those here who do seem to know! (Redplate ...are ya listenin?)
Let's ask then .....if what he says is true and they have run whatever it is they needed to run for the FDA ….is this something that may be considered to be early / late or on time …in terms of meeting a 1/01/07 deadline for formal BLA submission?
I suppose I mean …. how long do we think it will take, following the actual submission of the sample, for the CMC paperwork to be finalized?
Finally ..... throw this into the mix of the interesting conspiracy theories re: price/volume rise pre Friday's conference wire release ......i.e. .... in part could the word of a security guard on FDA watch somehow leaked …….?????
Guess we'll know if next time we kick down to Hanover he drives up in a mindight blue Aston Vanquish S. ...
ahhhh Dendreon ..... "....transforming lives
Anyone have link/summary pdf of the latest TRCA/dna brief?
seems its missing in my overview
And the presentation slides to with that news:
http://investor.dendreon.com/downloads/22568dndn.pdf
-- The overall survival benefit does not appear to be due to any imbalances in the treatment arms or the subsequent use and timing of chemotherapy. As published in the July issue of the Journal of Clinical Oncology, the Phase 3 Study (D9901) demonstrated a median overall survival of 25.9 months in the PROVENGE arm compared with 21.4 months in the placebo arm, or a 4.5 month survival difference. For these men, there was a 41 percent overall reduction in the risk of death (p-value = 0.010; HR = 1.71); and
-- An analysis of prostate-cancer-specific survival showed a median survival of 35.2 months for patients randomized to PROVENGE compared to 23.5 months for patients randomized to placebo, a difference of 11.7 months and a 50 percent reduction in prostate cancer-specific mortality (p-value = 0.002; HR = 2.04).
When to buy or add to position?
that line is the uptrendline...under 4,50 very close to bottom by now
heh, dew will put me in place (he disagrees on the first there)
but dndn/insm come close
GTCB is executing very well with the LFB deal, but this should be communicated as well and they should work on attracting more LT holders
GTCB should do more to support interest in the stock , i definately hope 2007 will make them attend more investor presentations, specifically pitching a 3-5year path starting with a boost from the fda next summer...and picturing how the LFB deal is a start to their intentions
some more focus there would be nice for those sitting it out with gtcb as some of us here are, i only recently started posting on the company
Check the deal summary i copied from ymb
summarizes exactly how i feel
and do not forget that the 25mln dont need to be all that is needed... from end of 2007 gtcb should have its own revenue streams to support investments..
and it IS how the company has allways communicated how they view their ideal growth model
offcourse gtcb has to bring items to the table
but they gain a lot by doing so
and the other plasma's are ideal for their model
Good recap on ymb for quick explanation
completely my view as well 100%
all 100% in line with gtcb policy and the policy newberry has communicated and confirmed last summer on multiple occasions
----------------------------------
The recent agreement (JV) between GTCB and LBF is dilutive, causing GTCB's shares to slide back after an initial pop.
To me, the major issue is not dilution per se, but what GTCB's shareholders get for the (20%) dilution?
To answer this question, one must first understand that LFB's parent is a (large) French state-owned company whose primary business is the production and distribution of plasma proteins derived from human blood.
The very existence of the GTCB-LFB agreement is a recognition on the part of LFB that GTCB's transgenic production platform is a superior (faster, cheaper, safer) way to produce plasma proteins, of which there are about 100 kinds.
The agreement calls for a 15-year (renewable) JV to "marry" LBF's experience in clinical development and regulatory review to GTCB's transgenic production platform. The first product will be Human Factor VIIa, which is already under development by LFB. LFB will have exclusive commercial rights to this product in Europe, and GTCB will have those rights in North America. For the rest of the world, and for all other products (both plasma proteins and monoclonal antibodies or MABs) they choose to develop, costs and profits will be split evenly, though there is a clause that allows for non 50-50 split of profits if one of the parties does not contribute to 50% of the costs.
Rather than simply outsource its (production) technology (to LBF), GTCB has chosen to partner with a major European company. As a result, the risks are higher (development costs + non-approvals of products), but the reward (as a percentage) of sales is also much higher, especially if compared to royalties had GTCB simply been chosen by LBF as the "fab" for its plasma proteins and MABs. In short, this deal by GTCB is an effort by GTCB to move "upstream" into a higher value-added market via a JV that will codevelop and distribute blood plasma proteins and MABs with a major European player.
There's no way to calculate if such a deal is worth a 20% dilution, but it certainly represents a another major validation of the potential value of GTCB.
Uptrend very much intact
http://img246.imageshack.us/img246/3076/dndnchartmm3.png
you must see the opportunities in the LFB deal
this IS one of the partners they desire
and they WILL benefit from sales, and not just get a production fee
well, the mere suggestion of them wanting a partnership especially seeing th LFB background.. only to suggest they want to sell the shares on the open market shortly after is ridiculous indeed
so no matter what phrasing, it never would be nice
the company is more likley to buy more shares gtcb than to sell them seeing the line of business they are in
All this is in line with earlier statements by the company and newberry
They were not looking to just be a production platform, but they were looking for companies to partner up with
The LFB deal is a very very large step forward to a stable revenue growth in the years to come
Yarbonero transcript: final part
--------------------------------
In summary androgen independent Prostate Cancer is a deadly disease. On the average these patients die in about 19 months. There's been a modest survival advantage but an important one seen with docytaxl regiments that provides about a 2.4 month benefit in median survival. The majority of patients are currently electing not to go Taxatere regiments mostly due to the side effects profile and the impact on quality of life which is highlighted by the S?2 study and there is clearly a need for better tolerated, new treatment options. We think we have theopportunity to provide that with our lead product candidate Provenge.
The data from our principle data study, the 9901 study was published in the July issue of the Journal of Clinical Oncology . This was the first ever randomized double blind placebo controlled trial for cancer immunotherapy. It enrolled 127 men with metastatic androgen independent prostate cancer at 19 centers across the US. The primary end point of this study was median time to disease progression and the study protocol required that we follow all patients for 3 years after randomization for the survival end point which is obviously the gold standard end point, not only in oncology but particulary in hormone refractory prostate cancer.
These are the curves that were published in the JCO article and here you see Provenge in orange, and placebo in green, and the curves separate very nicely from the beginning. There is a 4 1/2 month median survival benefit that achieved a statistically persuasive result, p value .01 and the hazard ratio of 1.7 suggests that there is a 41% overall reduction in the risk to death for men that got drug compared to placebo. Personally I like hazard ratios more than medians. Hazard ratios give you a better overall estimate of what the drug effect is as opposed to a point estimate such as medians.
What is really compelling is the durability of this type of product. So at the end of the study 34% of patients on drug were alive compared to 11% of patients in the control arm. So a three fold improvement in 3 year survival. Now this benefit is seen with very minimal toxicities. The most common side effect that are associated with Provenge is what you would expect from a cancer immunotherapy. There are fevers and chills, They are usually of low grade and of short duration. They last for about 1 or 2 days and then they go away. So in contrast to chemotherapy this is an extremely well tolerated agent.
So the 9901 study which is highlighted in blue is a primary study that we are using to support the biologics license application for Provenge. And again in that study we showed a 21% of 4.5 month improvement in median survival and a three fold improvement in 36 month survival. We tested the robustness of this survival benefit. This hazard ratio of 1.7 , a p value of .01 with a multivariate cox regression model to make sure that this survival benefit wasn't due to imbalances in other factors, other major demographic factors, And once we plugged that into the cox regression we can see that the p value stays strong, see that value of .002 and the hazard ratio went up slightly. This data set 9901, is supported by data from a second phase 3 study, 9902A as well as data from an integrated analysis of these two studies.
So from a regulatory perspective this is a product that has been residing within the CBER branch of the FDA and in particular the office of celluar tissue and gene therapies, In September of 2005 we held a formal pre BLA meeting with the FDA and they agreed in that meeting that the survival benefit observed in the 9901 study, supported by data from 9902A and the absence of any significant toxicity, that that data set would serve as a primary basis of our biologics license application. And it is important to note that this strategy is consistent with the current regulations for single study approval. The data is clinically meaningful, it's statistically persuasive, and it is supported by other data from other studies.
So if you look at the time line for the Provenge program going forward, we held our pre BLA meeting with the FDA about a year ago, in September of last year, and made a decision at the point to submit the biologics application at that time. The data was published in JCO this summer. We've completed the conformance runs now for the recombinant protein with our contract manufacturer Diosynth. That was a very important event for the organiztion. We've also completed the buildout of our New Jersey manufacturning facility which is the facitlity that will host the pre approval inspection with the FDA. That facility is still in the process of being validated. Once that's done we plan to complete the CMC section which is the final section of the BLA to the FDA which will start the PADUFA clock. We will also request priority review at that time. We anticipate that we will go in front of an advisory committee early in 2007, probably some time in the first quarter, with the potential approval by the middle of next year.
So this is really a near term opportunity for the company, near term opportunity for the patients and a near term opportunity for investors. It's been a long road to hoe, We've been working on this for over 10 years. But we are pretty excited about the packages wer are putting together and what it means for patients with late stage prostate cancer.
We have another study called the Impact study or 9902B. It's similar in design to the 9901 and the 9902A studies but it potentially allows us to expand the label into minimally symptomatic disease. So if you look at what we have ongoing with Provenge to date, the green area the studies that we're using as a primary basis of the BLA. We do have an interest into moving into earlier stage prostate cancer. We've completed two phase 2 studies, 9905 and P-16 which showed an improvement in PSA doubling time in those two studies. One was a model therapy study, the other was Provenge in combination with Avastin. We expect to get the results from P-11 study sometime before the end of this year, which is a phase 3 study in early stage prostate cancer. The primary endpoint there is a biological end point. Classically those endpoints have not been used, have not been acceptible for label expansion, but we do think that this will help educate the physician community on the potential utility of Provenge in early stage prostate cancer. The primary purpose of that study is really to use the patients of that study to supplement the overall safety database which the FDA has agreed that that safety database is adequate in size. And then the 9902B study, the Impact study that is currently enrolling, is actually enrolling very well right now. We expect to complete enrollment in that study next year. A little bit on that study, It's a large study, it's 500 ,men, similar in design to 9901 and 9902A, 2 to 1 randomization. It's enrolling at 70 sites. The primary endpoint of this study is survival. It's designed really off of the integrated analysis of 9901 and 9902A, so it's appropriately powered. It's being conducted under a special protocal assessment that we've agreed on with the FDA and the primary statistical tool to analyze survival will be the cox regression analysis and again patients from that study will be used to supplement our current application for the BLA.
The manufacturing process itself, from a commercial setting, a physician will write a prescription for Provenge, the patient will get a standard blood collection, a procedure known as a leukopharesis. That will be sent off to our commercial manufacturing facility in Hanover, New Jersey where it is combined witht he antigen delivery cassette of the recombinant protein and over about a 30 to 20 hour period that is cultured together and that is sent back to the physicians office for infusion which occurs over 30 to 60 minutes. It's a standard IV infusion , just like any infusion based medicine.
About half the physicians in our clinical trials are urologists and half the physicians are oncologists. They are very comfortable administering infusion based products. This process is repeated 3 times over a 1 month period, then the patients are done.
We have as I mentioned earlier, completed construction on our state of the art, first in class, manufacturing facility in Hanover New Jersey. It is 158,000 square foot facility, and we will be able to expand that facility as necessary.to really meet the commercial manufacturing needs that we anticipate for Provenge. Also we have completed the conformance lots of the recombinant protein of the antigen delivery cassette with our contract manufacturer Diosynth. That will all be included in the CMC section of our BLA.
From a marketing perspective I don't think that this is much different than other oncology programs. There's really 2 physician segments that we are going after. It's both Urologists and medical Oncologists. They are easily targeted through a sales force of about 98 reps and if you include the support personnel along with the sales reps it's about 125 total people in general which is easily managed by an organization like Dendreon. So we plan to commercialize this product ourselves in the US through this easily managed sales force and are seeking a commercialization partner outside the US. There is a hugh market for this patient segment with metastatic hormone refractory prostate cancer. We think the data that we have in hand and the favorable benefit to risk profile supports Provenge as front line therapy in patients with metastatic androgen independent prostate cancer. We will have some data later on in the fourth quarter that suggest that patients can go on chemotherapy and what that looks like with Provenge. It's an easily targeted customer base and we expect that pricing will very much be similar to other biologics that are currently available for patients with late stage cancer.
We are building a pipeline beyond Provenge, like early stage prostate cancer with Provenge itself but also into other antigen targets. We really want to leveage the antigen delivery cassette technology so we have a program that targets her2neu, called Neuvenge, and we will be studying that along with ovarian, colorectal, we are particularly interested in bladder cancer indication, ca9 for colon, lung and breast cancer, cea primarily for renal cell cancer and the trp-p8 program.
We currently have a very unencumbered, a very clean balance sheet. We ended the second quarter with 106 million in cash and no debt. So this has been a very productive year for Dendreon. We've submitted the clinical and non clinical sections of the BLA to the FDA in August, we've published our results of our principle phase 3 study 9901 in the Journal of Clinical Oncology and that was extremely well received in the physician community, we've completed construction of our manufacturing facility in New Jersey, and as I said we've also completed our conformanc lots with our contract manufacturer Diosynth. We published the results of the NCI study looking at Provenge in combination with Avastin in men with earlier stage Prostate cancer. Looking forward I think it will continue to be an eventful fourth quarter for the organiztion. We'll be completing submission of the Provenge BLA to the FDA prior to the end of this year. We are on track to do that. That's going very well. We'll report top line results from the P-11 phase 3 clinical trial Provenge in early stage androgen dependent prostate cancer and we'll have numerous scientific presentations in the fourth quarter that really highlight the robustness of the survival benefits that we've seen with Provenge. So as I said earlier I think that Dendreon provides a unique investment opportunity today. We have the potential to be the first active immunotherapy to market for patients with late stage prostate cancer. We're showing a strong survival benefit with a favorable safety profile. The physicians are clearly interested in a better tolerated treatment option for their patients. We own 100% of the worldwide rights to this program and we can move it both into earlier and later stages of disease. And once we get Provenge across the goal line, we will be able to invest much more substantially in our other assets and expand the pipeline as a whole. I thank you for our time today. I believe our break out is in the booth room downstairs.
Yarbonero transcript of the UBS presentation!
thank him for typing it out
------------------------------------------
Potential to be the first cancer immunotherapy to the market
Very strong survival benefit in phase 3 studies
Significant amount of interest by physicians in bringing better tolerated and less toxic forms of treatment to patients with late stage prostate cancer
We own 100% of the worldwide rights to Provenge
Studying Provenge in late stage Prostate Cancer and early stage
We believe our androgen delivery cassette technology has been validated with the survival data that we've seen in our lead study with Provenge and we can apply that to other antigen vivo types and toward other cancer indications
Active immunotherapy is much different than chemotherapy products - they are designed to be highly specific potentially affecting only cancer cells, very well tolerated when compared to traditional chemotherapies and they can be used both prior to and in combination with other agents.
Sees Provenge being used as front line therapy in patients with metastatic androgen independent prostate cancer but it can also be used with other products either in early stages of disease or chemotherapy can be added along with the regiment later on for patients with late stage PC.
Patient completes a full course of therapy with Provenge over a 1 month period. After they are done with that treatment protocol they can go on and live their normal lives so they don't have to go in every three weeks and get an infusion of a chemotherapy based regiment. That is an important feature for patients. The potential for the immune response to be durable is very important for these patients so we see that really bear itself out in the survival data from our primary phase 3 study 9901.
So why are we so excited about Provenge.
The data from 9901, a large double blind randomized placebo controlled study. It showed a 31% delay in time to disease progression which was a primary endpoint of that study, but more importantly it showed a 41% overall reduction in the risk of death, a median survival benefit of 4 1/2 months, and that survival benefit was statistically persuasive, with a p value of .01, and clinically meaningful. It's much more significant than what we are seeing with the current standard of care in Taxotere.
Most importantly Provenge was very well tolerated so that therapeutic index of this product was very different than what you see with traditional chemotherapeutic agents.
This is a new class of therapies and we believe that one of the key reasons we've had the success that we've had is because the proprietary technology that resides in our antigen delivery cassette. The antigen delivery cassette is something that is unique to Dendreon and there's two key principles behind it. First that we select a well validated and well characterized target, in the case of Provenge that target is represented here by the orange structure is prostatic acid phosphatase and we fuse that to a dendritic cell binding protein gmcfs and that fusion protein allows us to get much more efficient antigen uptake by the antigen presenting cells then if we just used the naked antigen by itself. 100% of our patients generated immune response against the cassette itself. That's one feature.
The second is that we manufacture this as a recombinant protein so we don't source our antigen from a patient's own tumor tissue and we don't source our antigens from genetic cell lines. We make this through standard manufacturing techniques and as a result it's highly scalable, we've scaled it up to 2000 liters, which is our commercial launch scale. But much more importantly from a regulatory perspective, it's extremely well characterized. So we know exactly what this protein looks like on ?pharesis.
shows a video of T cell activation
The audio stopped working so I will have to refer to my notes to see if I have anything to add besides this.
We're all familiar with the advent of monoclonal antibodies and what they meant to the treatment of different types of cancer. Monoclonal antibodies are a passive form of immunotherapy. You have to repeatedly administer those products. This new class of products known as active immunocellular antibodies is very different. Once you administer these products, the body creates a memory t cell response and they have the ability to stick around and be much more durable. Very similar to the immunizations we've received against pathogens such as measles, mumps and rubella. So we're leading the way in this first in class type of product to bring this type of product to patients with late stage prostate cancer.
So what's the need for a product like provenge?
If you looked at the spectrum of patients with prostate cancer today what's amazing to me is that while there are a million patients that have a diagnosis of prostate cancer, about a half of those men are currently being actively treated for the disease. It's usually they've been initially diagnosed, or they've been treated and they've recurred. The primary forms of treatment include surgery, and radiation therapy and sometimes cryotherapy. About 40% of those men will fail primary therapy, and they go on what's known as androgen deprivation therapy lhlr ?therapy. That's not a pleasant experience for most men. All men will eventually become resistant to androgen deprivation therapy, they become what is know as androgen independent or hormone refractory. And for those men there are few appealing treatment options available to them today. The label that we are currently persuing for Provenge, we're positioning it for frontline therapy for men with asymptomatic metastatic androgen independent prostate cancer. Taxotere is currently approved for asymptomatic men and in the asymptomatic study only about 5% of patients are currently electing to go on Taxotere. Once they are symptomatic it is closer to 20% of the patients are currently electing to go on Taxotere. So there is a hugh gap here and a need for treatment options that are better tolerated for patients with asymptomatic androgen independent prostate cancer, and that's what we're persuing with our BLA filing with the FDA this year.
If you look at the market size for this patient setting there is about 132,000 men with hormone refractory prostate cancer, of which about 96,000 are metastatic. It's a fairly large patient segment for us to be persuing on our primary label. Now this is the data for the Taxotere label. Again Taxotere is the only form of approved therapy available for these patients. The median survival benefit is 24 months, this is from the Tax 324 study which was published in the New England Journal of Medicine. That survival benefit is associated with significant ?morbidities and toxcities, the biggest one is being the male changes and the peripheral neuropathy, but certainly also the neutrapenic changes are debilitating for these patients. So it shouldn't really be a surprise, and this is a study that was conducted by the largest prostate cancer advocacy group, when they pulled patients to see how they were satisfied with the current treatment regiments, only about half of those patients said that they were currently considering chemotherapy as an option. When you actually look at the usage patterns it's consistent that you're seeing about a 14% overall penetration for Taxotere in patients with hormone refractory prostate cancer. So there is clearly a need for new treatment options.
Siga Technologies (SIGA - commentary - Cramer's Take) soared more than 80% after its merger partner PharmAthene received a contract valued at up to $213 million from the Defense Department Army Space and Missile Command. The contract covers the advanced development of the company's chemical nerve agent prophylaxis, Protexia. Shares of Siga climbed 85 cents to $1.91.
-----------
normal correction?
Adding in small increments.. all the big boys are waiting for tired retail to sell..
see it now?
Only 680k reported shorts left
Shorts interest decreased 2% or so..
i had expected a 500k rise or so due to the capping around the BLA announcement, apparently they managed to recuperate those shares allready...
add the 1 mln worth of call options.. and maybe some 700-800k of thsoe could be considered to be bought by shorts
all this could signal the first signs of some parties starting to cover
Option volume on 21st sept: 8390 call vs 252 put
as some sure noticed as well
quite the imbalance there
;o)
i also added more stock last friday, seems like oversold on technicals as well, although the hedgies might twitch it more leading upt to thursdays presentation (or try anyway)
hehehe i got it quite soon afterwards
damn funny msg though
;o))
made me smile, so thanks
;o)
Todays buyers from free level 2 capture
Todays buyers from free level 2 capture
Level 2 buy interest last friday
pretty clear that there IS buying going on while its painted down during the day
for those in denial:
Practical question: how do you post a jpg like that here?
than do not bother next time and skip your first msg alltogether as well, unless its really not intended as i read it, in that case i apologize, but seems unlikeley to me at this time
good luck
Again someone who sold and is hoping for a lower entry..
if you take TA than yes 1,19/1,14 support or ultimately 1,00 could happen, ie 1,19 did happen allready
your millions of shares around 1$ remark is bullshit though..
-Jun-06 1.83 2.00 1.62 1.81 11,438,100
forgot that one?
those who wanted a short trade took their profit that day and the weeks after it
And yes you might get a lower price than today if buy pressure stays low..
No catalyst for a price decrease though, only catalyst could be lack of interest.
But at the same time many private investors here and elsewhere are looking for some bargain shopping as well...
so you might aim a little too low..
Anyway.. point of my post is: next time try not to bs so much in your post when your intent is dripping so obviously through between the lines
Just related to somatropine, or could it affect all growth inducing therapies there
(about the side by side comparison study remarks)
seems is just meant for similar somatropin products and how they compare to each other
or thats how i read it
so dont think that affects things...
HOWEVER the huge time difference between the 87 day for trca for COMP designation.. and the 30 days for INSM COMP designation is still very interesting
------------------------------------------------
the time being, analytical characterisation and a limited non-clinical programme
alone cannot establish therapeutic equivalence of a similar biological medicinal product
with the reference product. In addition, IGF-1 is no established surrogate marker for
efficacy. Therefore, a clinical equivalence trial in a sensitive model is necessary. GH
deficient children are the preferred models because they are GH sensitive and represent
the classic indication for GH therapy for which most experience has been gathered and
for which equivalence margins may be easiest to define. However, a study in GH
deficient adults is principally possible.
The voiced fear that the requirement for a comparative clinical trial is a major
development obstacle is not confirmed by real life experience. In this respect it should be
pointed out that the applicant of a ‘biosimilar’ rHuGH will need to perform only one
rigorous comparative clinical trial in one indication with the possibility of extrapolation
to the other indications of the reference product.
Orphan drug status for TRCA and INSM
Insm orphan drug application approved during MAY 17th 2006 news issue after a 30 day review time
TERCICA orphan drug application approved during APRIL 6th news issue after a 87 day review
----------------------
TRCA:
http://www.emea.europa.eu/pdfs/human/comp/12557206en.pdf
Mecasermin, from Tercica Europe Limited, for treatment of primary insulin-like growth factor-
1 deficiency due to molecular or genetic defects (review time: day 87)
-----------------------------
INSM
http://www.emea.europa.eu/pdfs/human/comp/18025106en.pdf
Mecasermin rinfabate, from Insmed Europe Ltd., for treatment of primary insulin-like growth
factor-1 deficiency due to molecular or genetic defects (review time: day 30)
Now all this gets even more interesting.. apparently the US news did reach the US as well
because additional questions were presented, and TRCA was asked an opinion there..
so were there additional questions for TRCA where there are none yet for INSM?
(considering INSM was rushed through the COMP panel in 30 days, where TRCA was held up for 87 days)
http://www.emea.europa.eu/pdfs/human/biosimilar/8916606en.pdf
How does that fit into things than?
Doc. Ref: EMEA/89166/2006
the DATE of this pdf creation is:
(found in document properties ->description in adobr acrobat pro)
Created : 13-6-2006 at 10:54:45
Last modified: 13-6-2006 at 12:09:45
Hmmmmmm
So this new discussion is AFTER insmed was approved as orphan designation as well..and after insmed should have been moved to the CHMP agenda as well..
Any opinion there people?
EMEA and MAA
Assessment of marketing authorisation
applications The primary activity of the
“pre-authorisation” unit, through its two
scientific committees, is the assessment of
MAAs for new medicinal products and new
active substances. In carrying out the assessment,
the scientific committee concerned
(either the CPMP or the COMP) produces
an opinion which is then transmitted to the
European Commission for conversion into
a legally binding decision (ie, approval).
In 2001, the EMEA received 110 applications,
of which 58 were for new medicinal
products and 40 for new active substances.
The remaining 12 applications were for
products to be approved under orphan drug
legislation. Under EU legislation, an MAA
submitted via the centralised procedure to
the EMEA should take a maximum of 210
days to be assessed. All the applications were
assessed in 2001 within an average of 170
days, a timescale that does not include the
time taken for the agency to ask questions
and receive responses from applicant companies.
A further average of 76 days has been
required for the conversion of the opinion
into a decision by the European Commission,
and is the one aspect of the centralised
procedure that has received greatest criticism.
Attempts are being made to minimise
the delays in the decision-making process.
-----------------------------------------
Orphan medicinal products Orphan medicinal
products are used for the diagnosis, prevention,
or treatment of life-threatening or
serious conditions that occur only rarely and
affect not more than five in 10,000 people in
the EU. Under normal circumstances, the
high costs associated with the development
of new medicinal products would preclude
the likelihood of pharmaceutical companies
generating a profit from developing medicinal
products for such conditions. The EU
has therefore followed the example set by
the US in passing orphan drug legislation,
through which incentives are offered to
companies that carry out research and
development to produce medicinal products
for such rare conditions.
The incentives that have been agreed
under Regulation (EC) 141/2000 are:
Market exclusivity will be given for 10
years after the granting of a marketing
authorisation (ie, during that period,
directly competitive similar products
cannot usually be placed on the market)
There will be provision of scientific
advice from the EMEA to facilitate the
development of the medicinal product,
and guidance on preparing an MAA that
will satisfy regulatory requirements.
This will maximise a company’s chances
of getting a medicinal product approved
There will be direct access to the centralised
procedure, allowing the
approved product to be marketed in all
EU member states
Reduced fees are offered for both scientific
advice and the submission of the
MAA, using subsidised funds from the
European Commission that have been
agreed annually by the European Parliament
There may be financial assistance to
companies and organisations developing
orphan medicinal products through
grants from community and member
state programmes and initiatives supporting
research and development,
including the community framework
programmes
Designation of a product as an orphan
drug and its assessment is carried out within
the EMEA by the COMP. The COMP has
one representative nominated by each
member state, three from patient organisations
and three from the EMEA.
The COMP has 90 days in which to
approve (or otherwise) a request for orphan
drug designation; a positive opinion on the
designation is then forwarded to the European
Commission, which has a further 30
days in which to confirm the opinion and
issue a decision. Once this is completed, the
medicinal product is placed on the Register
of Orphan Medicinal Products.
In the early period of the operation of
the COMP, most of the medicinal products
that were granted orphan drug status were
for the treatment of cancers, immunological
diseases and metabolic diseases often related
to enzyme deficiencies. Equally importantly,
about two-thirds of the products were for
the treatment of children, who have traditionally
been a group for whom pharmaceutical
companies have been reluctant to
devote time and resources because of the
relatively small potential market. Examples
of medicinal products that have been designated
as orphan medicinal products since
2000 are given in Table 1.