I never said Iplex was not a useful drug. It has the potential to be one of the most useful drugs in human medicine. What I said a long time ago, now echoed by Zake, is that INSM could never develop the drug based upon how the company was run, their misunderstanding of the science associated with the drug and the lack of medical direction. Why they did not do a Phase IIa/Phase IIb for ALS, why they chose MMD based on DM1 mutation versus MMD/Duchennes/dystrophin are the two reasons why Iplex is registered as a "discontinued drug" with the FDA. It is also why Iplex is now outlicensed to Premacure (their website now statest that they have exclusive World Wide rights to market IGF-1/IGF-1BP-3 for ROP). Sweden has one of the best health care delivery systems in the world and I do not doubt that Premacure will follow through and get Iplex approved undera an EMEA application. Sweden is also one of the richest countries (per capita) in Europe, so they have the resources to manufacture.
It is too bad that INSM did not continue along with its plans for Iplex because in fact, IGF-1 is going to become very important in another medical area very soon. It has to do with multiple modality therapy which will be done in three baby steps a few days apart. It will be classified as a multiple modality therapy, like physicains will be employing for many diseases in the future. What is interesting is that 2/3s of the drugs are already approved and are administered by the safest routes. Go figure. Molecular changes that lead to cytopathology are basis of diseases . . . and offer the best basis to correct diseases. Just change things back to normal and let the body heal itself.
But Iplex is not viable in the hands of INSM, but is in the hands of Premacure. That is what I have contended since INSM switched to Arikace.
I think iPLEX has the potential to never be produced again.
I think that has a much better chance then your "most useful drug ever"craziness.
Is this what this board will bring for the next year while we wait for REALITY about ARIKACE????posting about a drug that failed and is no longer produced?
oh, brother! Iplex is "discontinued" for neither reason you provide. You have no clue to the iPlex development program and management's strategic rationale. Such the expert! And your expertise on Premacure is dumbfounding...you probably think Premiplex is not be being produced. Oh, wait....nothing is real until the clinical trial info is updated.
Those who follow the FDA know the when and why this piece of "legislation"
A couple of years ago,Commissioner Hamburg was under strong Congressional scrutiny for being "too cautious"
The FDA was throwing everything back.....Obesity.... diabetic.... cancer drugs....
It was making for bad press so the FDA did a public relations campaign with stories such as the early marketing "legislation"
Like Dr Mc McClellan's pitch to fastrack every diabetic and cancer drug during the Bush adm,this piece of PR has had the same effect....... nothing...except to have the gulible believe their drug is the one!!.
FDA scrunity to allow drugs to gain approval is a long through process ( at Governmet speed)
The FDA did approve 3 obesity drugs,their "timeline was increased by a couple of years"
A CF launch in late 2014 is very optimistic IN EUROPE ONLY- a pittance in the land of price regulated markets.........by that time Insmed investors will know if NTM proceeds to Phase3, or if Insmed is Insmed and this piece of drivel from Evelyn will be just another example of her knowing nothing about everything.
Since Clown 1 and Clown 3 have both decided to comment within this thread and Clown 3 wants a "material event" . . . I offer the opening page statement at PremacureDOTcom:
"Addressing Unmet Medical Needs for the Neonate
Premacure AB, located in Uppsala, Sweden owns exclusive worldwide rights to develop and commercialize Insulin-Like Growth Factor 1 (IGF-I) together with or without its natural binding protein, IGFBP-3, as a product for the “prevention of complications of preterm birth”." So Clown 3 is:
1. Too lazy to do any DD on Premacure to vaidate his/her/its own statement and/or disprove the statment by Premacure (not me).
2. Too stupid to figure out what the term "exclusive world wide rights to develop and commercialize" really means.
3. Too stupid to fiture out that if INSM has outlicensed Iplex rights, files, etc. for a percent royalty ONLY and that Premacure is proceeding on its own to get to a Phase III trial going and licensed a medical product. Read the info on ClinicalTrialsDOTgov and see that Premacure is the "regualtory authority" for the clinical trial and beyond.
4. That based upon 3 above, that Premacure will be the first company to have the right to manufacture Iplex/Premiplex since March of 2009.
5. That if any potential investor still believes that Iplex/Premiplex is an important medical product, they should follow the future accomplishments of Premacure and see if any investment opprotunity opens-up in the next one or two years. I sure am BTW because Iplex figures prominently in several healing pathways that I am aware of.
But follow Clowns 1, 2 and 3 and do the INSM buy low - sell high - rebuy on the dip thing that has been promoted by the manipulators of this stock. Ignore any facts than have to do with killing bacteria. After all, it is an antibiotic in name only until proven!!!
Rumdumm - As much as I would like to spend some time responding to yet another incredibly pompous and yet totally ignorant post on tour part, I will defer to a Terry_Insm post in response to you:
Nuff said. You have captured the attention of an investor that has doubled his money every year for over a decade, but still tries to protect all of us foolish Insmed investors. He not only agrees with you, but occasionally spends time adding to your own thumbs up ratings. You have reached the top of the mountain!
But follow Clowns 1, 2 and 3 and do the INSM buy low - sell high - rebuy on the dip thing that has been promoted by the manipulators of this stock. Ignore any facts than have to do with killing bacteria."
Oh pleeease.I have profitted almost doubling my investment every year for more than a decade. You preach the science of poor investment
If you were responding to my post, then you ARE an idiot. I started my post with a quote from terry's post (I was responding to him), who gives your posts the thumbs up ;); so the "material" subject was raised by terry. Read and understand.
Why don't you answer the questions directed to you by me and Historian in this thread? You continue to bloviate, name call (impressive for a "doctor", yeah really), and post with multiple ID's. Transparency and honesty are simply not within your character, that is too bad for you. Read my post and specifically respond to the questions, do not make stuff up to post and think you are impressing someone.
If any investors want to get back into Iplex/Premiplex they are going to have to wait for Premacure to go public in Europe. That appears to be next on the horizon for Premacure. I think they might even be able to get Sweden's backing bacause of the socialized medicine approach in that country. The Swedish government funded Dr. Michael Ley's expanded study of Iplex several years ago in which he looked at the pulmonary dystrophy condition in premies. It is part of the same premature birth syndrome.
Not sure what your point is, but you are consistently pointless!
Insmed has licensed Iplex to Premacure, not sold the IP to them. The potential for revenue streams exists, without costs associated with development.
We agree. I have often posted I hope Insmed monetizes Iplex and sells it to someone
who can invest and advance the drug.....Premacure ....still has not been a comittment towards development producing or trialing to start the path to approval.- That requires cash .............and for Iplex, Lots of it..... It is very expensive to produce.
Does Premacure have the ok from IPsen?Genentech? No,that also that would be a material event.
Investors on this board know Insmed is arikace, so Iplex "news soon! and such
are worthless to investors, and have been for a long time .......... Iplex to science has yet to be seen.beyond early work.
Iplex is "evolving"
By terry_insm.Nov 23, 2012 Seems rehdvm2004 and zake1 have ,after 3 and a half years have finally realized the minimal value of Iplex.
IPlex has never been any sort of share price driver since Dr Alllan and the company dropped the drug in JULY 2009. ( Read the PR)
PCUT which is fodder for novices is a compassionate org with no funding.
ROP is in the clinic
Not 1 investment penny has stepped forward to restart Iplex.
Insmed is all about Arikace,especially NTM...but first a word from our sponsor about the 26 M betting parlor.
Zakes post is a dose of reality to the realization that someone will own Insmed if it hits on NTM.
No one knows the valuation metric now, but I do realize what slick Willy's plan is.
imho I doubt he's not doing much on the groundwork that Whitten laid out, warts and all.
Will Lewis is a hedge fund manager,not a physician or scientist....
"Does Premacure have the ok from IPsen?Genentech? No,that also that would be a material event."
From teh recent Q3 CC, Lewis said:
"We are underway in that regard as you know, with respect to Premacure. We've signed an amended agreement there. We have one waiver in place with Roche. The second, with Ipsen, is pending signatures. So we feel good about where that is. I think any further licensing activity that
may be underway or in discussion, as soon as we have progress made that's definitive and material, you can be assured that we'll disclose that."
Does that answer your pretentious questions?
"...the earth is certainly out of its' orbit...".
H, if anyone wants to know how to get the earth back into its' orbit, just reach out to rehdvm2004...he's got the answer(s).
What he said a long time ago is now "echoed" by Zake. Glad he pointed that out, now all are enlightened.
"It is too bad that INSM did not continue along with its plans for Iplex because in fact...". The die was cast with the patent infringement/settlement agreement, for a given amount of time. Insmed did not have the resources to pursue development of Iplex, even with the lifeline from Merck, that would not be a viable option. Hence the Transave merger and the decision to utilize the resources to advance Arikace and to out license Iplex. Now he is saying that is the correct decision? Wow, he is also a business genius!
If he has all these answers, he should be consulting for companies, providing them with his "valuable" guidance. However, he is here, providing all his valuable information and guidance for free.
Amazin', simply amazin'.
Talking of Zake - I was rather hoping that he or any of the other Longs who have been here since the Celtrix days would respond to my take on the patent infringement issue (at the end of the thread you addressed to me).
Taliking of Rehdvm - I hope everybody who uses this forum is alive to the manner in which he avoids commenting upon any argument which implies that Arikace could be launched next year.