Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Twisting Insmed
The reality of Insmed is surely distorted here,from when( how long) a trial lasts etc.early 2009 is the opt in decision if Insmed makes it there.This using the CEOs own statement.
Insmed is obviously not close to an agreement for a partner in the Biologics field,using the CEOs own statements yesterday.
Naturallt throwing around Billions and Insmeds plant is sheer folly.
then there is this
"INSM has already produced several of these drugs at their Boulder plant(don't know which ones), "
This is a flat out falsehood.Please call the company to see which proteins the Company is "working on "
When their are guidlines,now presumably not until next year more specifics would come on which the company _ could- produce - with the help of a partner.
NO,good companies are never cheap.
I guess losing money(34 cents a share) is worser than saying the Company has spend huge amounts of money for manufacturing and research and development(which will bear fruits this year( Obesity results will move the stock)...
What will that 1.1Billion in the bank buy ? :))
jmho
Re: LAR ,AMLN
Marsico,Hambrecht,Goldman recent comments would disagree
(buy on weakness Meg Malloy said @40).. but analysts like your Opinion is respected."lofty valuations" is always nonsense.Its what the market will bear.
LAR is almost finished its 30 week trial.Its important to note that at the halfway point Amylin increased its plant investment (to mfg LAR) from 200M to 650 M in Ohio.
Although the trial is only blinded to Amylin itself,results can be known. The phase 2 LAR results of course blew everyone out of the water.Glucose control,weight loss effect were 50% better than the "gold standard" of 1% reduction.Also down sharply was the nausea effect that has turned off some Physicians and patients...why ? LAR is a polmer that slowly dissloves.the dosage; is constant and ongoing, hence the better glucose control etc seen were due to dosage "smoothing out"as oppossed to the twice daily injection now on the market. What is hinted from those I've talked to(and No I'll just post this,not refer to it)is that the current trial is TWICE as long as the Phase2 - 15 trial..so what are the results of an even smoother dosage?
You will see in a couple of months,and when the "Gold standard is eclipsed even more,investors will come to realize what those who attended the ADA meeting did.LAR will then become a first line therapy.
Orals are for GP's who know little about diabetes.The disease needs to be treated much earlier/ stronger than the pill so often prescribed as the patient drifts into pill land. 2/3rds simply fail orals and in the interm the disease progresses.I am describing a paraidgm shift in diabetes treatment.
At the ADA meeting,opinion was LAR Launch would be at the end of 2008.
Liraglitude? you mean the once a day injection with inferior results ?..sorry I just had to laugh that one off,even if they both arrive on market 2009,LAR will swamp Liraglitude.
at 33 cents its almost lights out for that technology which has failed trial after trial.
Amylin has inked deals with Alkermes and Nastech(nasal spray formulation)
mindless drivel...
As you can see the poster asks in a previous post to stop the subject of another Company you mentioned in a thread,only to answer your investment with mindless drivel.
why are posts being delted here?
Most of us that took a beating with Insmeds inabilty to parner.to address the legal aspects for shareholders,to insure shreholder equity are hanging on.Can the Company survive another year? IF the stock market takes a big fall due to other factors?(terrorism?Dow collaspes,or one of the trails fails?
(that of course( say HARS fails the dosage trial2b)will kill Insmed as we know it and it would be pennies on the dollar.
I dont see any other reason for the Company to appreciate unless the market helps.
Source of "stated current negotiations"
I believe Dr Allen said he hoped for by "late this year"
and
Source of
"Five biologics currently in developement for generic market."
Insmed source please
Short term scenerios are an unknown.
The Vote will allow the FDA to change rules on approving Biologics.It MAY be an incentive for a partner for Insmed,in any case Revenues from biologice is a few years out.
DNA will partner if they think one of Insmeds Orphan drugs will make them money and has a good chance to pass the large late stage Phase 3 trial.but also not till late next year, if they decide to "opt - in "
There are currently no late stage trials ongoing.The Company hopes for a partner and would like to start the Phase 2b trial next year for HARS and MMD..ALS is the other possible indication.It is an unknown on what speed the Italy trial is taking or when data will be available to decide if Insmed and others wat to proceed.
Insmed needs money to make the pipeline start to show its possible potential.Hope this helps
What this is then is guidlines upon which the FDA will take years to act on.For those of us that have seen the speed of the FDA- Good Luck
The essence of the Bill therefore is to move the FDA in a direction to act.Insmed has years to get a partner to finance any products in the future.
Accomplia was DOA if you read the AMA article and their recommends to the FDA
Avandia is 1 guy analayzing 1 way
So avandia gets a stronger warning on the bottle- Avandia has long been known to add edema and weight.
Amylin is the big weight loss winner with both of these areas and when results from amylins drugs with Leptin are announced, a watershed......Obesity - the holy grail of Pharma
Novo Nordisk.
LAR needle, Home health and other disinformation
http://www1.investorvillage.com/smbd.asp?mb=2885&mn=24842&pt=msg&mid=2201604
dew- what do you think is a good value in biotech..since you seem to be negative all the way around....
Accomplia is heading for the inevitable approbale letter= a new longer trial will be asked for by the FDA.SNY and the FDA are negotiating, but its hopeless. After last years scathing JAMA recommendation that the psychotic episode were too much ( not to mention a large dropout rate),the AMA said the most reasonable approach was to do a longer trial ( 2 year Phase3)-
SNY is saying to the FDA - but its already for sale in the EU ! I doubt Accomplia sees the light of day for 3 years, and when it does will be labeled for death.
BTW - if you look at the results for glucose control weight loss and every other thing SNY says Accomplia can do( smoking has already been nixed)- there are better choices
pipelines are shrinking everywhere
At first I thought you were sincere about LAR, now I see its a spam tactic,possibly coinciding with the Barrons Piece(of garbage). Since the final trial of LAR is open label,we know the number of patients that have a "problem" with "the needle.
The number is ridiculously small, but your spam to the IV AMLN MB clearly has an agenda- keep it to yourself.
BTW- ? do you know that trial results have shown LAR has almost doubled what was considered the "gold standard" for glucose control for diabetics,and the weight loss has not yet plateaued after 3 years of data, and that there is mounting evidence to support Byetta enhances beta cells ?.
Please do DD on "needle phobia- it's a "media issue" (where you got this story) - in the real world of diabetic therapy- it's a non issue, so please - get real
You are not informed on the advantages of Byetta or LAR over their competitors.
Byettas filament needle in a pen is virtually painles.
Dew dilligence- Byetta and "competitors" have a very large field to serve.
Pills , usually thought to be the domain of GP treating dibetics..GPs write 2/3rds of the Byetta scripts.
Amylin has flooded the market with freebies because of a earlier mistake of not being able to handle the demand. The demand is there, and when they all stary paying...
Amylin will get its first billion( I think by late next year)
as quickly as AMGN...
Merck, Novo...everybody wants to be Byetta,but none are close.
The weight loss characteristic ,3 (THREE) phase insulin resonse
and beta cell enhancement make it the obvious leader.
LAR will be introduced as a needle( given by a doctor once a week to insure compliance,along with a TZD. This will be the "standard of care" for diabetics.Certainly thought leaders and endos know this.
Valuation is very low considering AMLNs expanding pipeline.With the Byetta,Symlin Leptin coctail results to be announced the second half,- it will show that this cocktail for weight loss may be the holy grail( Phase2)
http://www1.investorvillage.com/smbd.asp?mb=2885&mn=17982&pt=msg&mid=1411738
note: Barrons - home to the "cancer"scare of Byetta last year( totally unfounded)
There are investors and there are medical professionals- believe the above post - he is
In 25 words or less , Is TRCA going for "all or nothing " ?
Can a Jury verdict possibly force Insmed to stop selling their drug ?
I haven't followed the legal proceedings,and my source for this Co ,bailed out even.
The last consensus was a royality was the most probable outcome,but has TRCA a chance to clog Insmed (or force a deal ?)
Thanks- this has been painful
Wowe ! poorgradstudent !!- TELK ?
If the FDA approved Tericias drug with no questions asked( they deemed it safe enough), why do you think EU will ?
( EU usually follows the FDA )
IGF-1 will simply beat TRCA in the marketplace.
The exclusive distribution agreement entered into in September 2002 by the Group with Genentech covers NutropinAq®, a liquid formulation of human growth hormone produced using recombinant DNA technology. Under this agreement, the Group has the exclusive right to market worldwide (with the exception of North America, Mexico and Japan) NutropinAq® and the NutropinAq® Pen Cartridge (i.e. the configuration used for the daily administration of the liquid formulation of NutropinAq®) and any improvement made to these products.
Ipsen signed with Genentech a R&D agreement in November 2004 covering the development of sustained-release formulations of recombinant growth hormones using the technology platforms of Genentech, Ipsen and third parties
Ipsen acquired Sterix also
Filing an NDA this year with the FDA.
Interesting
"Another thing about the Byetta approval - insmterry might note that the primary clinical endpoint for the FDA approval was - guess what! - HbA1c reduction at 30 weeks. After all that hoopla about how FDA supposedly changed all its thinking - the "new paradigm" etc. where tracking of HbA1c was dismissed as simplistic..."
I'm sure terry can answer for himself,but I find it truly amazing that your answers are always wrapped around Amylin.Did terry mention this,or as Byetta's current Phase 3 LAR trial(open label)shows(and his point was),convincing the FDA to take a different approach to drug approvals.
Yes, I find it hard to believe that someone"who attended the Symlin meeting",had to explain away(went to the label- a giveaway) no T2 hypoglycemia- an issue very much discussed at the FDA meeting.
The paradigm is changing..in diabetes,and at the FDA- this may bode well for Insmed in the future.
It is no longer about a simple number.
Dr P