------------ Worst Call Post of the year ? -----------
dorianrivers21 • Feb 21, 2014 " The $50 target pps I have is for June/July"
------------ Best Post of the year ? ----------- (NTM)
Possible scenario by terry_insm • Apr 15, 2014 4:50 PM
"The FDA mandates a Phase3 trial which should take 24-30 months before the FDA decides"
*** FRom a 500 million dollar opportunity to No US sales (repost)
This indication is easier to evaluate because the US market which was 400 Million of that 500M has vanished. ( bugsey? Is this bad?? )
NTM could be a big winner but suppose the Phase3 results are weak and Arikayce is approved for refractory only patients ?
I blush because I nailed the "telegraphing" that Insmed knew if the results were inferior the FDA would say No way in the USA
terry_insm • Jul 10, 2013 ****** Strategy emerging? - FDA US no longer presented.
"So were do we go with this data? " ---to Europe 2015 - Will Lewis
Just one problem with this outcome The US is where the big money is.
The company's glaring omission of the U.S FDA or possible launch may well be the company's plan going forward. Insmed declined to do a trial in the US.
Hypoglycemia is a Well-Established, Dose-Limiting AE Associated with Exogenous, Free rhIGF-I Administration.
To read more, check i-hub
Part 2 Enlarged tonsils. IPLEX may enlarge your child�s tonsils. Some signs of enlarged tonsils are snoring, problems breathing or swallowing, earaches, problems hearing, and breathing problems during sleep (sleep apnea, which can also cause excessive daytime sleepiness). Call your child�s healthcare professional if your child gets any of these symptoms. Your healthcare professional should do regular exams to check your child�s tonsils.
Increased pressure in the brain (intracranial hypertension). Signs of increased pressure in the brain include headache, nausea, vomiting, and vision problems. Call your child�s healthcare professional if your child has these symptoms.
A hip bone problem called slipped capital femoral epiphysis. This happens when the upper end of the leg bone (femur) slips apart. Get medical attention for your child right away if your child develops a limp, or has hip or knee pain.
Worsened curve of the spine (scoliosis). If your child has scoliosis, your child will need to be checked regularly for an increase in the curve of the spine.
Allergic reactions. Your child may have a mild or serious allergic reaction to IPLEX. Call your child�s healthcare professional right away if your child gets a rash or hives. Get medical help right away if your child has trouble breathing or goes into shock.
It is especially important to tell your child�s healthcare professional if your child takes insulin or other medicine s for diabetes. A dose change may be needed for these medicines.
How Should My Child Use IPLEX?
Use IPLEX exactly as prescribed for your child.
Your child�s doctor or nurse should teach you how to inject IPLEX. Do not give your child IPLEX unless you understand all of the instructions.
See the �Instructions for Use� that come with IPLEX.
IPLEX Approved 2005
Patient Information Sheet Approved 12/2005
Date Created: February 2, 2006
Part 1 = As a parent of two small kids, I wouldn't dream of giving them this stuff. Better short than dead!
What Is IPLEX?
IPLEX is an injectable prescription medicine that contains man-made insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3). IPLEX is used to treat children with severe primary IGF-1 deficiency. Children with severe primary IGF-1 deficiency are very short for their age because their bodies do not make enough IGF-1.
IPLEX should not be used in place of growth hormone. IPLEX is not for other causes of growth failure. IPLEX is not for children less than 3 years old or adults with primary IGF-1 deficiency.
Who Should Not Be Treated With IPLEX?
Your child should not take IPLEX if your child:
has finished growing (bone growth plates are closed)
is allergic to mecasermin rinfabate or any of the inactive ingredients in IPLEX.
Never inject IPLEX into a vein.
WHAT ARE THE RISKS?
The following are the major potential risks and side effects of IPLEX therapy. However, this list is not complete. Call your child's healthcare professional if your child has side effects that bother them, or do not go away.
Low blood sugar (hypoglycemia). IPLEX may lower your child�s blood sugar levels the way insulin does. Do not give your child IPLEX if your child has signs of low blood sugar which include dizziness, headache, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea, or fast or irregular heartbeat.
Severe low blood sugar may cause unconsciousness, convulsions, or death. Your child should not do risky activities until the healthcare professional has found the right dose for your child. Before beginning treatment with IPLEX, your child�s healthcare professional should explain to you the symptoms of low blood sugar and how to treat it.
Iplex 2009 a young Doctor contribution to this board All Rights for ROP SOLD for 11 Million
by internatnight • Jun 28, 2009 8:48 AM Flag
Except for the obvious here,Iplex is dead.
Iplex was poorly received in the short stature market,most likely has shown little benefits in ALS and has proof positive that it is not an effective therapy for MD.Forget the made up stories that the trial design was poor or that ALS will bring a bonanza of money,Iplex is dying,if not now completely dead.An ALS trial asked for by the FDA because they knew this all along will never happen ,and Iplex will now lose its myth status for the poor desperate patients that may have money to try Iplex.I see some are trying the diabetes angle again,or maybe HARS will turn up ,all ineffective in the days of drug cost control.
INSM as an Investment is the prayer someone will come along and pay money for ROP and Cancer.Cancer is worth little as is ROP, so will someone pay money for money?
The SP is this high I guess so some -with money can get out.
Dream somewhere else
any way you slice it ! Insmed has been a TURKEY this year!
Be thankful we are ONLY down 17%
2015 I think down 30%
Give Thanks! this Thanksgiving that INSM is not down more than 17% , that we at least got some partial good news on NTM even though Arikayce failed the PRIMARY Outcome
INSM doesnt need a sales force in the USA for Cystic Fibrosis because there will be no sales
We only got diluted twice! That the FDA will rule in 3 years and didnt just say Arikayce failed the trial
The Short interest increases by 4 % last 2
jad9000 Sept 30, 2014 - "Their problem is that they can't shake any shares loose anymore and the big boys are in cover mode. " LOL !
We got some partial good news on NTM even though Arikayce failed the PRIMARY Outcome
That INSM doesnt need a sales force in the USA for Cys Fibrosis because there will be no sales
That we only got diluted twice!
That the FDA will rule in 3 years and didnt just say Arikayce failed the trial
INSM is not down more than 17% !
Can Insmed file with the EMA a "dual" filing for 2 different indications? with the same drug?
Insmed has told its investors it can.
The FDA NTM Phase 3 trial will start recruiting next year with results in 2017. Remember the good ole days when Insmed told investors the company had 2 commercial ready indications that in 2014 would be selling....then,,, 2 indications on 2 continents in 2015. Now we have nothing in the US till 2017-2018 . , and yes I do question the viability of this "dual filing" ( 2 indications and 1 filing.) If EMA accepts the filing and will rule ( and they say so) on such, I will enter a position, but I like others are not convinced. I dont have to tell rational investors the results should the EMA decide to wait for the FDA trial.
Dorian : I keep seeing these crazy predictions. INSM is down 22% this year .You should get out of the share price prediction business. "" dorianrivers21 • Nov 19, 2013 "Which is why we see $20 short term. " ======dorianrivers21 • Nov 27, 2013 "My revised pps for next year is $42-50. "
Steve Cohens purchase of 2 million shares last summer would be the way to do it Using Point72 Asset management and absorbing a Institutional seller.
You should get out of the share price prediction business. dorianrivers21 • Nov 19, 2013 "Which is why we see $20 short term. " ======dorianrivers21 • Nov 27, 2013 "My revised pps for next year is $42-50. "
justarook04: the information you posted as being helpful to NTM results are to be discounted. The FDA Phase lll is the FDA and only the FDA. Results are due in 2017.