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rtn,
Thanks for keeping this great resource updated. Much appreciated. Slacker
Tercica expands relationship with Lonza.
If Insmed's manufacturing process is so good and we can obviously make the product since they sued us for infringement why wouldn't Tercica use ITP to manufacture Increlex?
Confused?
Nice find rod
Now that looks like an agreement between two parties who when put together make a stronger entity. Now our agreement ... not so much.
I only hope INSM has secured some funding through this deal at specified gates which they are very close to achieving. If that definition is the one they use, we could get funding at any time.
Still trying to follow the dollar. Can't quite figure it out yet. theonlyslacker
chem - great to see you still here.
I still don't get how this settlement could be perceived as anything but INSM getting bent over the proverbial desk.
1) We gave up our only approved indication after spending a truckload of money to get it through the FDA and another truckload getting close to approval in Europe.
2) We are returned to a development company with no indications beyond Phase II and no money to develop them.
3) If by chance we survive long enough to get one of the indications to Phase III DNA/TRCA gets the option to "invest" half our expenses, after much of the risk has been removed by the way, and take half the profits.
4) Did not see any up front monetary compensation for giving up the indications and we are pretty much out of money. Who is going to partner with us for our half of the profits of any indication?
Wow. Another education in how the big boys play the game. I am on this ride until the horse it gallops or dies. Sure do hope it gets up on all fours soon. theonlyslacker
We should not forget it is possible that both of these hearing delays were forced by the judge to allow both parties to assess risks of proceeding without a settlement. We may not be close to a deal at all.
Can someone with experience in these negotiations handicap the possibility we are still miles apart?
Respectfully,
theonlyslacker
How about 1 share of DNA for every 10 shares of INSM. Deal?? Slacker
rfoable,
Most likely the jury had no idea how much iPlex has been sold since that is not relevent to the discussion of whether or not they infringed the patents. That is why they established ranges.
The judge will establish the ongoing/future royalties assuming she does not decide that an injunction is the most appropriate remedy.
Hope this helps. Slacker
The jury probably put the second level of damages in because they most likely had no indication as to the amount of iPlex sold. That would be irrelevant to the discussion of patent infringement. Slacker
If we have a mistrial, wouldn't it be in TRCA's best interest since they could just restart the process and tie INSM's PR and monetary resources up for another year plus? They have money and we do not. Another trial would keep a cloud over this stock for a long time and not sure we can raise the money necessary to withstand.
Other factors to consider:
1) Is DNA obligated to engage in a another trial or have they completed the contractual requirements by standing with TRCA through this one?
2) Has it been concluded that the new versions of iPlex are not covered by TRCA's patent and therefore another trial would be a moot point or only impact the revenue generated up to the point where the new version is being used?
Love to hear other throughts. Slacker
I believed toonce, I believed.
Everyone get ready for the fun part of this ride, IMHO
Slacker
I have to think that the invite from NASDAQ for Geoff Allen to sit on a panel to discuss AIDS has got to be good news. Any reason other than the pending trial the market would not have jumped all over that news?
We have HIV Lipo and MMD news coming out within the next 6 - 9 months. European approval (fingers crossed) in 2007 which could(dare I say should)include partner. Shelf stable version of iPlex coming out in 2007 which could negate patent issues...
Only downsides are trial unknowns and Insmed management's propensity to go it alone which may require further dilution.
All IMHO of course. Happy Thanksgiving. Slacker
Here, here Cashquest.
I hope this is the year for the party at Wrigley.
Good to hear some of the long longs who have been so educational and willing to share back on the old Yahoo board.
Happy Holidays. theonlyslacker
Thanks for posting drbio. I don't know about the rest of you all, but in my opinion this indication is the one that will put INSM on the map. Larger market, study funded by someone else (adds validity to indication), no other solution so process should be easier to get approval (assuming necessary, off-label should catch on pretty quickly). IMHO. Slacker
drbio,
You have to love how much weight this analyst gives INSM/iPlex in this report. He says most of the success will happen in the less severe IGF deficiency market because INSM will not be in that market. Sounds to me like an admission that INSM will beat TRCA in the markets they compete in. NICE!
I was amazed they did not mention how long they have been looking to fill the trial slots for this drug. They have been trying to sign up patients for a long time and are still only 60% and 57% filled. In a market stout enough the base a majority of the future of this company valuation on and no current solutions, you would think people would be diving all over themselves to get in. Doesn't that give him some indication how bad this drug is for patients (children)?
No mention of Europe either. Admission we will beat them there also?
November will be fun - trial and full quarter financials. Mmmmmmmm. Slacker
ThomasS,
Intelligence in the market is based on a risk reward correlation as well as an opportunity cost based on that correlation. In this case the unknowns and therefore the "risks" are pretty high but the reward is also potentially high. My point is just because the market has not embraced INSM does not necessarily mean they know something we do not.
Place your bets as intelligently as possible and roll the dice.
Slacker
Love me some abharploonta. Posted on YMB. Thanks for taking time to inform us all. Slacker
by: abharploonta
Long-Term Sentiment: Strong Buy 07/05/06 07:57 pm
Msg: 114117 of 114136
I suppose the pumpers and the bashers are going to try and spin any news to suit their own motives, but the confusion abounding on this MB today is astounding.
First, partial summary judgement means only a partial resolution of the case. Nobody wins. Nobody loses. At least not on June 30, 2006. The case is not yet decided. Only parts of it, and only those parts which one side or the other asked the Judge to consider, and only if the Judge found no evidentiary conflict which would require jurors to resolve that particular issue of fact.
Also, for the Plaintiff to win a patent case, Plaintiff must first prove infringement of a patent granted by the U.S. Patent Office. Next, the Plaintiff must also prove that the patent they claim was infringed is, in fact, a valid patent. The issuance of a patent creates a presumption of validity. The Defendant then has the burden of overcoming that presumption.
So, TRCA did get some good news from the Court. But it did not get any sort of decision which will entitle it to damages of any sort from INSM. It is only part of the way there, hence the term "Partial Summary Judment". I agree it is unsettling to see TRCA land even one punch, but the fight is far from over.
Some folks seem to clearly understand these points, and have moved on to discussing INSM's chances of prevailing at trial on invalidity issues. Others seem to be clogging up the MB with useless posts based upon a false assumption or conclusion that infringement is the be all and end all in patent litigation.
Certainly, TRCA's PR preyed upon a layperson's misconception and lack of understanding of the legal terminology. I can't say the TRCA PR contained any lies, though. The Court ruled that that INSM had infringed on three claims within one patent. TRCA still has to survive validity challenges at trial in order to receive damages.
Bottom line: the case is still going to trial in November, to be followed by appeals, which have at least a 50-50 chance of succeeding.
I haven't analyzed the invalidity defense retained by INSM. I probably, like most of you, lack the scientific background, highly specialized legal training, and weeks of time to do so (assuming the key evidence is available on PACER, when I know tons of it has been redacted and/or sealed from public view). But yakking about this stuff in general is good entertainment, so have at it.
It sort of makes sense to me that if a claim is broadly drawn, it is easier to establish that the Defendant's product infringes on the claim in some fashion. But this would appear to be a double-edged sword for the Plaintiff, since a broadly drawn claim would logically be easier to invalidate. The larger the claim, the bigger the target. The larger the perimeter, the tougher to defend.
Bottom, bottom line: Nothing really has changed on the legal front since last week. For all we know, INSM might be delighted with a broad claim construction and well prepared to rip the validity of the claim apart at trial. As a long, I sure hope so.
Those of you with legal expertise, please clarify some things ... I was under the impression the courts did rule that INSM had infringed on portions of the patents but did not go so far as to rule on all issues and would have to do so at trial. Because of this situation the courts could not rule on damages or stop INSM from making and selling iPlex. True assessment???
If this is a good assessment than am I correct in anticipating there to be a long legal guantlet to run including a trial and anticipated appeals process. All the while INSM is positioning itself for other indications and other markets not impacted by the patents?
Finally, what is the potential that TRCA/DNA could get an injunction at any time during this long process that would require INSM to stop producing and selling iPlex? and is it possible the courts could impose a forced settlement in the form of damages or royalties?
Thanks. Slacker
galt,
Don't lose faith. This is typical for INSM. Until we actually start to show some revenues and can either prove the revenue value of these indications or actually prove some off label usage or announce a partner with revenue implications (this appears to be what moved WGAT), this will continue to run up before news and fall off on announcement. Can't tell you how many times I have been head faked by this stock. One of these times it will run up and stay up. I have stopped trading this stock because I think that time is coming soon (6-18 months). However if you do not mind losing out on that large run it is pretty easy to accumulate shares since this type of action is pretty easy to anticipate.
Great science will reward long term holders. Slacker
Thanks, as usual, for the education Bob. Learned a lot from you over the years.
TRCA can take down the Kingsbridge funds at will for an average of the past 8 days PPS or $3.00 whichever is greater. Correct? Therefore wouldn't it seem reasonable that unless you really got a large bounce from this PR it would have limited impact since the stock price has fallen pretty badly over the past couple of weeks?
Second, wouldn't any investor/banker in their right mind look at the steep decline in share price (granted it could be the result of anticipated dilution) and the meager quarterly results even considering first to market position and flinch at buying this at or near this current price? Therefore with the intention of an offering, this line of reasoning would continue to drive share prices lower. Right?
Finally, realistically in order to afford this treatment, a family would either have to have insurance or be fairly well off to afford either of these options. So competing on price seems to be a weak market tactic.
We will see the impact of the PR early today on the SP. Quite possible I am overthinking this thing but it seems reasonable whatever TRCA is trying to do they need more than the $75M available from Kingsbridge. Looking forward to the education. Slacker
I am still very confused. TRCA's management team must have a strategy and this PR must be part of that strategy. It is not like someone shoved a microphone into the CEOs face and got an off the cuff remark. This was a PR that required thought and effort ... so what is the purpose from TRCA's perspective? Are they really thinking of competing on price in a niche market? How can you establish an acceptable differentation in price to offset the safety of the drug in children? They have to know that branding Increlex as the discount option could have a negative impact on sales, damage profit margins and drive PPS to unrecoverable lows.
If you were on the TRCA management, what possible overall strategy would this PR help accomplish? Slacker
blissonmoon,
If you read further the poster who mentioned PFE and DNA recanted and said he was "kidding" (not funny, I know). There is a poison pill from way back that makes a hostile takeover highly unlikely. Based on the apparent view of the current management they have always had a propensity to go it alone in hopes of reaping all the rewards (either a very deep belief in the value of the drug or a stubborness. I like the first story best). Partnership is a possibility on some of the indications IMHO.
The $22 target a few years ago was before a 1 for 4 reverse split and prior to the failure of INS-1 in diabetes trials. INS 1 was Insmed's original drug candidate. Somatokine(now named IPlex) was acquired when Insmed purchased Celtrix a few years ago. This stock has been in the low $.30 range in October 2002 just after the failure of INS-1.
One might question whether I have been here too long, huh? Always believed in the science, have received one hell of an education, and made a little money along the way.
GLTA! Slacker
Thanks Coin. Got that ... are there any issues with switching kids who are taking the frozen version over to the room temp version when it becomes available? Thanks. Slacker
Does anyone know if there are issues with switching from frozen IPlex to the room temperature version when that becomes available? Slacker
All,
Does it make more sense to partner in markets based on specialization? I am not sure how the medical industry is set up but it would seem that some specializations (like Pediatrics) would be harder to break into with a new sales force/product than others. When considering the small "approved" market for iPlex it may make sense to partner now, focus around development/approval of new(more financially rewarding)indications and eventually develop sales forces around markets that are easier to enter and/or provide a larger return.
As stated the real return for INSM is not necessarily in this market (pediatrics). We could spend lots of much needed cash entering a market that would immediately be capped (no more opportunity to sell other indications). Cancer and Diabetes is where control of distribution would be most appropriate for long term return.
Any validity to this concept?
Slacker
Coin - thanks for your efforts around this site.